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  • Swine Flu AND Medical News Concentrator January 1, 2013 To April 25, 2013. 242 comments
    Jan 3, 2013 7:16 AM

    This instablog is designed as an interactive News Concentrator devoted to news and discussions about Swine Flu and other medical news.

    The top portion of the instablog contains useful background information/ charts.

    Up-to-date news content is posed in the comments area. So if you are interested in current news, read the comments.

    _____________________

    Update History:
    Added definition of Reassortment
    Added definition of R0 (R Naught)
    Added Overview of H1N1 / Categories of Vaccine Investment Plays Added Memory Alpha
    Added Link to Google's Swine Flu Infection Map
    Added Red Cross Tips for Dealing With The Flu
    Added definition of EUA and PREP act
    Broke Swine Flu Concentrator into two parts for October
    Broke Swine Flu Concentrator into three parts for October
    Added Swine Flu Concentrator November Part 1
    Bolded References to Older Swine Flu Concentrators in Memory Alpha
    Expanded the list of stocks discussed in the tags
    Alphabetized stocks in the tags
    Updated the play by stock list
    Added a table that contains the web site addresses for the companies discussed
    Moved links over one month old to the new Memory Alpha Reference Library
    Added definitions of Clinical Trials and Protocol.
    Corrected Roche stock symbol in the web site table
    _____________________
    Last Swine Flu News Concentrator Links:

    Swine Flu AND Medical News Concentrator October 13, 2012 To December 31, 2012.

    tinyurl.com/agndtk4

    Swine Flu News Concentrator June 13, 2012 to October 13, 2012

    tinyurl.com/9l3u3d6

    Swine Flu News Concentrator July 30, 2011 to June 13, 2012tinyurl.com/6nfvspe

    Swine Flu News Concentrator May 12, 2011 to July 29, 2011tinyurl.com/3m7hcfp

    Swine Flu News Concentrator March 22, 2011 to May 12, 2011
    tinyurl.com/3hgogm4

    Swine Flu News Concentrator February 20, 2011 to March 22, 2011
    tinyurl.com/4unv2hy

    Swine Flu News Concentrator January 28, 2011 to February 20, 2011
    tinyurl.com/4u9nlrz

    Swine Flu News Concentrator January 11, 2011 to January 28, 2011
    tinyurl.com/4maxxdv

    Swine Flu News Concentrator December 18 (2010) to January 11, 2011
    tinyurl.com/4gs9xzl

    Swine Flu News Concentrator November 11 (2010) to December 18, 2010
    tinyurl.com/22pykd8

    Swine Flu News Concentrator September 23 to November 11 (2010)
    tinyurl.com/29eflnpJ

    Swine Flu News Concentrator June 14 to September 23 (2010)
    http://tinyurl.com/294bzc6

    Swine Flu News Concentrator April 8 to June 14
    tinyurl.com/25lqvfx

    Swine Flu News Concentrator (March 13 - April 8)
    tinyurl.com/y8w7mgy

    Swine Flu News Concentrator (February 12 - March 13)
    tinyurl.com/ykba7dl

    Swine Flu News Concentrator January 25 to February 12
    http://preview.tinyurl.com/yjccho4

    ___________________
    Some Definitions:

    What is Reassortment

    When two different virus strains infect the same host, they often exchange genes, a process known as reassortment.

    A significant number of experts are concerned that as H5N1 (Avian Flu) spreads more widely and infects more people, it will come across more hosts who are also carrying human flu viruses. This increases the likelihood of a new strain emerging that has the severity of the bird flu virus and the infection rate of the swine flu virus, leading to a new global pandemic with much deadlier consequences than the one we are experiencing at the moment.

    What is R naught (R 0)

    How many people the average infected person infects is called the basic reproductive number, or R0 (pronounced "R naught").

    Measles, which is probably mankind's most contagious infection, has an R0 of about 18. Polio's number is about 6; severe acute respiratory syndrome (SARS) about 5. For seasonal flu strains, the R0 is about 1.2, and for pandemic strains it is rarely higher than 2. For the novel H1N1 strain, it's about 1.6. What this low R0 means is that flu outbreaks are always teetering on the verge of having their myriad chains of transmission broken by people who get infected but don't pass the virus to anyone else.

    Swine Flu - Novel H1N1 flu, popularly known as swine flu, is a respiratory infection caused by an influenza virus first recognized in spring 2009. The new virus, which is officially called swine influenza A (H1N1), contains genetic material from human, swine and avian flu viruses. (By Mayo Clinic staff)

    Pandemic - The word "pandemic" comes from the Greek "pan-", "all" + "demos", "people or population" = "pandemos" = "all the people." A pandemic affects all (nearly all) of the people.

    A World Health Organization phase 6 pandemic indicates that influenza due to the novel H1N1 swine flu is occurring in multiple countries around the world and that human infection is widespread. The classification does not reflect the severity of individual infections.

    Cytokine Storm -
    When our body detects foreign micro-organisms indicating an infection, our body might respond by over-protecting the site of infection. The body may race so many antibodies to the infection site that they collect in what is known as a cytokine storm.

    A cytokine storm, or "Hypercytokinemia" is a potentially fatal immune reaction consisting of a positive feedback loop between cytokines and immune cells.
    www.wisegeek.com/what-is-the-cytokine-st...

    A positive feedback loop means that as something increases, that increase stimulates further growth.

    What makes younger people more susceptible to H1N1 is that their "vigorous immune systems pour out antibodies to attack the new virus. That can inflame lung cells until they leak fluid, which can overwhelm the lungs.

    This vulnerability in the young is reminiscent of the Spanish flu of 1918. That strain of flu also struck mostly healthy young adults.

    Pulmonary Embolism - Occurs when a blood clot forms in an arm or leg breaks free and enters the lungs where it is too large to pass through the small vessels of the lungs and forms a blockage. This stops blood from flowing into an area of the lung, and the part of the lung dies because it does not receive oxygen.
    medicalnewstoday.com/articles/153796.php

    What is an Emergency Use Authorization (EUA)?
    An EUA may be issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.

    What is the PREP Act?
    The PREP Act authorizes the Secretary of the Department of Health and Human Services ("Secretary") to issue a declaration ("PREP Act declaration") that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.

    The PREP Act also authorizes an emergency fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of a countermeasure covered by the Secretary's declaration. While no funds have been appropriated for this purpose, if funds are appropriated, compensation may then be available for medical benefits, lost wages and death benefits to individuals for specified injuries.
    cdc.gov/h1n1flu/eua/qa.htm

    What are Clinical Trials:
    Clinical trials, also known as clinical studies, are research studies in which scientists and doctors test new drugs and treatments to see if they will improve health. Many of today's treatments for cancer are based on the results of past clinical trials. Because of progress made through clinical trials, many people treated for cancer are now living longer.

    Clinical trials are divided into four phases.
    Phase 1 trials: These trials are the first time a new drug or treatment is given to humans. They are normally carried out in a small number of volunteers (typically 6-20 people) who may include healthy volunteers or patients with the disease for which the product is intended as a treatment in order to find out how safe the treatment is. They also look at how a new drug should be given (by mouth, injected into muscle or the bloodstream, etc.), how often and at what dose. Phase 1 trials can also involve patients for whom standard therapies have failed and for whom no other therapies are available.

    Phase 2 trials: These trials involve larger numbers of people (typically 12 - 50). Phase 2 trials continue to look at safety of the therapy but also test how well the new drug or treatment works in patients with different disease types.

    Phase 3 trials: These are large studies (100+ people) that look at how well a new drug or treatment works in comparison to current therapies to see which treatment is better. Those taking part are usually divided into two treatment groups: standard treatment versus new treatment.

    Phase 4 trials: These trials are usually carried out after the drug or treatment has been approved by the FDA and is readily available for use in the general patient population. The purpose of Phase 4 trials is to continue to study the effects of the drug or treatment on different populations and to look for side effects associated with long-term use.
    Back to Top

    What is a Protocol:
    Clinical trials use written guidelines called protocols. The protocol explains what the trial hopes to accomplish, how the trial will be carried out, and why each part of the trial is necessary. For example, the protocol includes:

    * The reason for doing the trial
    * How many people will be in the trial
    * Who is eligible to take part in the trial
    * What study drugs participants will need to take
    * What medical tests participants will have and how often
    * What information will be gathered

    Every doctor or research center that takes part in the trial uses the same protocol. This makes sure that patients are treated identically no matter where they are receiving treatment, and that information from all the centers taking part can be combined and compared.

    Why Slow Production for Traditionally Produced (chicken eggs) Swine Flu Vaccine:
    One dose of swine flu vaccine for every two eggs, compared with two doses of
    seasonal flu vaccine per egg

    Sorry if the link does not work... it appears the Boston Globe newspaper appears to be playing games with link addresses... Just copy the link, and Google it.

    http://www.boston.com/business/healthcare/articles/2009/10/22/quest_for_swine_flu_vaccine_giving_some_firms_a_boost/

    _____________________
    Brief Overview of Categories of H1N1/ Vaccine Investment Plays:

    I - Vaccines / Prevention
    1) Production Method / Capacity plays (NASDAQ:NVAX) (NASDAQ:VICL) (NYSE:NVS) (NASDAQ:INO) (NYSE:CSL)
    2) Nationalistic / Population Size Play (SVA - China) (NVAX - India)
    3) Injection / Vaccine support services (syringes etc.) (NYSE:BAX) (NYSE:BDX)
    4) Outsourced production plays
    5) Bio -Defense (MDCGF - France)
    6) Anti-Mutation / Pan-Influenza Play (NYSEMKT:CVM) (NYSEMKT:NNVC) (INO)
    7) Universal Flu Vaccine Play (INO)

    II - Treatment After Infection Occurs:
    1) Dealing with severe lung infections (Fludase® (DAS181)) (NYSE:CBM) (OTCQB:AEMD)
    2) ICU treatments (NASDAQ:BCRX) (NYSE:GSK) (NYSE:ROG)
    III - Population Avoidance:
    1) masks/ disinfectants… Surgical masks are good enough (NYSEMKT:APT) (NYSE:MMM) (NYSE:CLX) (NYSE:ECL) (OTCQB:PURE)

    IV - Testing do you have it? (NASDAQ:GPRO)
    1) Test kits - (NYSE:DGX)

    V - Merger / Acquisitions / Licensing (VICL) (NVAX)
    _____________________
    Sorry this is still a graphic instead of a table. I played with the table tool, but its a
    PITA to work with.

    Swine Flu Companies Discussed and Their Web Sites

    _____________________
    Swine Flu Hits Stuffed Animal World:

    2011 H1N1 US Flu Outbreak Map:
    Here is a link that gives information by US states. The Link is from DoubleGuns
    tinyurl.com/6khyjq
    ___________________

    Red Cross Tips For Dealing With The Flu:

    IF YOU ARE ILL -
    * Stay in a room separate from common areas of the home and avoid contact with others as much as possible.

    * Stay at home for at least 24 hours after their fever is gone without using medicine to reduce the fever.

    * Get lots of rest and drink plenty of fluids.

    * Consider wearing a face mask, if available and tolerable, when sharing common spaces with household members. (ed - surgical masks ok).

    * Check with your healthcare provider about whether to take antiviral medication, or if fever persists, whether antibiotics are needed.

    WHEN CARING FOR SOMEONE WHO HAS THE FLU -
    *Disinfect door knobs, switches, handles, toys and other surfaces that everyone touches.

    * Use detergent and very hot water to do dishes and wash clothes. It's okay to wash everyone's dishes and clothes together. Wash your hands after handling dirty laundry.

    * Designate only one adult as the caregiver. People at increased risk of severe illness from the flu should not be caregivers.

    * Although not mentioned by the Red Cross, the caregiver should probably ware a surgical mask as well when entering the sick room.

    * Deal with crisis situations calmly and confidently to give the best support to the person being cared for.
    _____________________

    MayoClinic.com Provides Credible, Up-to-Date Information And Decision-Support Tools For Flu Season

    Click here to link to the Mayo tool:
    www.mayoclinic.com/health/flu-symptoms/F...

    _____________________
    Suggested Protocol For Schools To Decide When Flu Should Trigger A Shutdown
    www.medicalnewstoday.com/articles/169984.php

    After comparing more than two dozen possible scenarios for closing a school, the analysis suggested three optimal scenarios:

    1. A single-day influenza-related absentee rate of 5 percent

    2. Absenteeism of 4 percent or more on two consecutive days

    3. Absenteeism of 3 percent or more on three consecutive days

    Disclosure: (sometimes trading, sometimes holding)

    Disease outbreak map on Globalincident.com

    tinyurl.com/c8f3do

    Link from Guns and OG.

Back To FocalPoint Analytics' Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (242)
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  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Vical Incorporated (VICL) announced that, effective, January 2, 2013, listing of the company's common stock will be transferred to the NASDAQ Global Select Market, the highest of the three market tiers at NASDAQ. Listing on the NASDAQ Global Select Market is reserved for companies that meet the highest quantitative and qualitative listing standards, reflecting their demonstrated commitments to leadership and good governance.
    ----

     

    January 3, 2013 - (VICL) announced that the company's CEO will provide an overview of the company's technologies, development programs, and strategic partnerships at the 2013 J.P. Morgan Healthcare Conference on Thursday January 10, at 12:30 p.m. PT.
    --
    PS: VICL has a nice chart of its pipeline on the front page of their website.
    3 Jan 2013, 08:20 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I plan on updating the information in the header of this instablog to reflect a broader informational scope that has investment implications.

     

    Let me know what you think would be a good idea to include.
    3 Jan 2013, 08:30 AM Reply Like
  • magounsq
    , contributor
    Comments (980) | Send Message
     
    FPA

     

    Biotech (R)Evolution...?
    Coming up short, but good idea to update the header.
    3 Jan 2013, 10:57 AM Reply Like
  • magounsq
    , contributor
    Comments (980) | Send Message
     
    FPA

     

    Emerging Biotech (R)Evolution Scoreboard?

     

    Sub focus....phase I, II, III...especially those in the phase cycle that might move pps?
    4 Jan 2013, 12:28 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I like that scoreboard concept Maqounsq...
    4 Jan 2013, 12:30 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Jon, do you want more than flu?

     

    If so, add Zogenix...after a flop on the pain drug without Acetaminophen which the FDA is now going to have a 2 day debate on it....ZGNX just had positive phase 1 trial on a new Schizophrenia drug.

     

    It's a stock to watch. As is GERN & BCRX, they have to rebuild a pipeline but are cheap and could go up with news.
    3 Jan 2013, 08:34 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Yes, beyond just flu...
    3 Jan 2013, 12:15 PM Reply Like
  • robert.b.ferguson
    , contributor
    Comments (10802) | Send Message
     
    RNA Imuno therapy?
    3 Jan 2013, 04:12 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » That's another good one... What I am thinking of is to include an overview summary of the topical areas in the header along with a quick review of the key companies involved. Then the comments section would be used to post news about the topical subjects and the companies.
    4 Jan 2013, 01:55 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    LT,

     

    The zgnx trial is not a new drug, it is a depot generic of a drug that has been on market over two decades, Risperdal, the first of the "second generation" or "atypical" antipsychotics. Risperidone is now available generically as one of the least expensive in the class.

     

    From yesterday's press release, zogenix "today announced positive single-dose pharmacokinetic (PK) results from the Phase 1 clinical trial of Relday", an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia."

     

    Subcutaneous is a novel way of administering risperidone, as the usual monthly depot form is an intramuscular injection, brand name Risperdal Consta.
    4 Jan 2013, 02:35 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    To expand on above comment about Relday subcutaneous depot risperidone:

     

    Long-acting injectable antipsychotics are recommended in patients that have very poor adherence to their oral medication schedules, usually because they remain suspicious of medications and unwilling or reluctant to take them. The once or twice monthly injections take more time and clinic visits for medication administration (and hence cost to the health systems, which are mostly public health care in the case of chronic schizophrenics), compared to prescribing pills, but can improve outcome and reduce hospitalizations in poorly compliant patients (which can reduce long-term costs for this subset).

     

    I did a quick search for articles that discussed the prevalence of using depot antipsychotics (also called "neuroleptics" in the medical lit) to see if I could come up with a good estimate of how many patients may be prescribed long-acting injections (depot neuroleptics) to treat chronic psychotic illness. European studies suggest about a quarter of schizophrenic outpatients receive such treatment in France and the UK. I could not find similar recent surveys for North America, but one study suggested the rate is probably much lower and many articles decry the underuse of such treatment.

     

    It is a small but steady market, and if Relday can demonstrate any meaningful improvement over Risperdal Consta (side effects, outcome, etc.) or substantially lower cost, then it can compete in this space. But it is not a new blockbuster in the field, just a me-too knock-off of a standard drug with a novel mechanism of administration. I am not sure of the advantages of subcutaneous over IM administration, but perhaps it is less painful and better tolerated by patients who don't like getting a shot in the derriere.
    4 Jan 2013, 03:16 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Emergent BioSolutions (EBS) has received the exclusive right to manufacture and sell VaxInnate's flu vaccine.

     

    The Biomedical Advanced Research and Development Authority (BARDA) established Emergent as a Center for Innovation in Advanced Development and Manufacturing in June. That 8-year, $220 million contract helps advance development of chemical, biological, radiological and nuclear medical countermeasures and domestic pandemic influenza vaccine. Emergent's agreement with VaxInnate for an undisclosed amount helps the company fulfill that contract.

     

    VaxInnate relies on TLR technology to produce vaccines as soluble biopharmaceutical grade proteins in bacteria. Such vaccines can be developed and manufactured on a large scale and fast, two necessities when a pandemic strikes.

     

    In 2011, the company signed on to earn up to $1.25 billion over 5 years for providing 44.8 million doses of its BioThrax anthrax vaccine to the U.S. government. Emergent has a hold on the anthrax vaccine market, with BioThrax bringing in $88 million in the first half of 2012. http://tinyurl.com/a59...
    ---
    I am not familiar with the TLR technology. I will be researching that and adding it to the concentrator in the near future.
    3 Jan 2013, 12:14 PM Reply Like
  • robert.b.ferguson
    , contributor
    Comments (10802) | Send Message
     
    Galena Biopharma (GALE) has reported good results from it's Phase II trial of Neuvax. It has dropped from it's high last year of $3.54 and plans a public offering which includes warrants. http://seekingalpha.co... When they place the offering I will double down on the stock. If all goes well I will be able to execute the warrants at a later date to good effect. As always DD is a must. Thanks for recovering and maintaining this concentrator FPA. I consider it to be one of the most valuable on the web.
    3 Jan 2013, 04:23 PM Reply Like
  • robert.b.ferguson
    , contributor
    Comments (10802) | Send Message
     
    RXI Pharmaceuticals (RXII) will present by webcast at Biotech Showcase 2013. http://yhoo.it/ULd8b1 Disclaimer: This is the parent company of (GALE) and I'm long both stocks.
    3 Jan 2013, 06:02 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    Early flu season accelerates; no peak yet, CDC says

     

    http://nbcnews.to/138CuRZ

     

    Love this blog, FPA!
    4 Jan 2013, 03:02 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    Tracking flu near you:

     

    https://flunearyou.org
    4 Jan 2013, 03:07 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    12:46 PM Zogenix (ZGNX +6.7%) moves up after announcing its preliminary Q4 sales figures today. The company expects gross product sales of approximately $13.5M on 145,200 units shipped, with unit volume up approximately 9% sequentially from Q312 and 26% from Q411. For FY12, preliminary unaudited net product revenues were around $36M, up 18% over FY11, but slightly below previously issued guidance of $37M. Separately the drug developer adds that it's filed for a $75M mixed shelf registration. [Healthcare, On the Move, Earnings] Comment!
    7 Jan 2013, 02:53 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Yes....but not Rattie.
    8 Jan 2013, 01:46 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    3 speculative Flu stocks:
    http://seekingalpha.co...
    11 Jan 2013, 03:52 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » January 11, 2013 - Influenza has officially reached epidemic proportions in the United States, with 7.3 percent of deaths last week caused by pneumonia and the flu, the U.S. Centers for Disease Control and Prevention said on Friday.
    11 Jan 2013, 05:55 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    Sangamo BioSciences: A Potentially Revolutionary 2013:

     

    http://bit.ly/V5SvEI

     

    In medicine, there are certain watershed moments that become an enduring part of medical history, such as the discovery of penicillin, or the eradication of smallpox. Sangamo BioSciences (SGMO) has a chance of joining the ranks of such key medical milestones, as the company is working on one of the greatest unmet needs in medicine - a functional cure for HIV and AIDS. Sangamo is set to report new clinical data regarding its development-stage HIV/AIDS treatment this year, and if all goes well, the stock will soar as the market for an effective treatment remains wide open.

     

    ####

     

    SGMO is up around 300% in the last 14 months. Further than what this article writes, is that SGMO is working at a DNA level to cure all viruses that affect plants, insects, animals and humans. I own a few shares of SGMO, and sure do wish I owned a lot more.
    16 Jan 2013, 05:50 PM Reply Like
  • Stefan Moroney
    , contributor
    Comments (2620) | Send Message
     
    Hey FPA -

     

    HTL mentioned that a couple people over here might appreciate this regenerative medicine state of the industry presentation.

     

    Hope someone finds it useful.

     

    http://bit.ly/V8ihMg
    16 Jan 2013, 09:18 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Thank you Stefan!
    16 Jan 2013, 09:31 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Alarming news about a possible link between narcolepsy and the GSK pandemrix vaccine:

     

    http://reut.rs/V43rkB

     

    A very complex statistical problem, detecting a real relationship with low numbers of affected cases out of 30M vaccinated individuals. But it deserves further research.
    22 Jan 2013, 08:56 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » This is indeed terrible news. It appears the treatment has somehow managed to alter brain chemistry, but only among the younger participants. The number of younger participants affected suggests it's not affecting all younger participants, just some of them.

     

    In addition, the onset of the adverse effects appears to have been sufficiently delayed to allow the adjuvanted vaccine to get through a large sample clinical trial. This raises the possibility of a maturation by treatment interaction. You can't simulate a maturation by drug treatment interaction with an age cohort design. It has to be a longitudinal design studying the effect of the vaccine in the same individuals over-time. The adjuvanted GSK vaccine came out in 2009, so it appears the trial period would have to be measured over at least two years. However, in the case of a pandemic Flu vaccine, the need for the vaccine is almost immediate. So there is a conundrum. There is no time to perform a long-term longitudinal study. For the Sweeds, the vaccination has been credited with saving 30 to 60 people [I assume that's a total estimate], but since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.... [Also don't know if those 200 reported cases were confined to the target age group... ] At any rate, you get an idea of the risk ratio issue facing the public health officials.

     

    So far, the issue appears to be associated with GSK's adjuvanted vaccine Pandemrix. It's unknown if the adjuvanted aspect of the drug is the problem. But because the US does not allow adjuvanted vaccines, the drug was not available in the US.

     

    (GSK) is up this morning, but I suspect it will drop as the ramifications of the news sinks in.
    22 Jan 2013, 11:27 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    FPA,

     

    the other part of the conundrum is that the signal is so low that we cannot be sure it is real, and the clinical trial that got the vaccine approved could never have detected it if it is real.

     

    800 cases out of 30million = 2.67*10^-5 incidence of the "Adverse Effect"

     

    Multiply that incidence by the 3600 in the trial that got it approved and you get a rate of 0.09 cases of the adverse effect out of 3600 participants. That is essentially a signal of zero. The original trial could not have detected this AE, if it is real.

     

    The 800 cases of possible AE always has to be weighed against the outcome of *not vaccinating* 30million people, which could be thousands to millions of deaths.
    22 Jan 2013, 12:18 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Further,

     

    The prevalence of narcolepsy in the European population may be even higher than the AE incidence reported in this article. Studies that have examined the epidemiology of narcolepsy in Europe find an incidence in the 0.026 to 0.047% range (around 25 to 50 cases per 100,000):

     

    http://bit.ly/XUFbUn

     

    http://bit.ly/140WSGd

     

    http://1.usa.gov/XUFbUu
    22 Jan 2013, 12:33 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I don’t think the problem is strictly focused on the ability to statistically detect an effect. In other words, a statistical power problem. From what I am reading, the onset of induced narcolepsy was not immediate; it manifested itself substantially after the treatment. That raises a big issue.

     

    Pandememic Flu threats have to be immediately addressed. There is no time to conduct a long-term clinical trial. The longer the delay for the onset and detection of the negative effect after the treatment, the less likely its gong to be picked up in a typical clinical trial. In order to pick up a time delayed effect the clinical trial would have to be extended over a period of at least one year, perhaps two.

     

    My takeaway is that in order for manufacturers and health systems to take full advantage of a rapid vaccine manufacturing system they need to make the first human clinical trial very much larger and extended in time over a period of at least a year, and perhaps more. In fact, the test should be continued even after the vaccine is approved for distribution. This would increase the testing costs, but it would also allow the manufacturer and health system to take better advantage of the rapid vaccine manufacturing system.

     

    Just for fun, I did some power analysis on the numbers to see what kind of N they would have needed to pick up an IMMEDIATE effect of induced Narcolepsy.

     

    Here are the key points:

     

    The total N of the clinical trial was 3,600. That study is reported to have been conducted among Children, Adolescents, Adults and the Elderly. This suggests four age Cohorts or 900 per cohort.

     

    I am assuming they did not screen out people with narcolepsy.

     

    You gave us the typical incidence rate of narcolepsy in Europe as between .00026 and .00047. Lets average that out to .00036 as the average background incidence proportion.

     

    The article tells us that the rate of Narcolepsy they are seeing among young people that got the injection was 7 to 13 times higher than the background rate. The average of 7 and 13 is 10. That gives us an average effect proportion of .0036.

     

    Assuming an average power of 80% and an alpha rate of .01, they would need an N of 3,310 in the YOUTH cohort.

     

    Since they could not know in advance what age cohort the effect would be located in, that would mean they would need 3,310 per age cohort, or 13,240 total. They would need an N that was 3.7 times larger.

     

    If they used an alpha rate more associated with life and death decisions, they would use alpha .001. That would take me to a sample size per cohort of 5,962 or 23,848 total. This gives us a needed N that is 6.6 times larger than used.

     

    Of course, as previously stated, they would also have to use an extended time study in order to pick up the onset of delayed effects. The longer the study the greater the dropout rate, so all the numbers would have to be enlarged by the expected dropout rate.

     

    What does this say about the investment advantage of rapid vaccine manufacturing systems?

     

    Is the advantage mostly lost because of a bottleneck associated with clinical testing? Or should legal limitations be extended with qualifications, for providing people with quick access to potentially lifesaving vaccines?

     

    22 Jan 2013, 03:41 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    I appreciate your power analysis.

     

    But a confound that remains is that narcolepsy typically has its onset in adolescence and young adulthood, and goes undiagnosed for years:

     

    http://bit.ly/10F1WAf

     

    So any study that attempted to look at an adolescent/young adult cohort would need a large control group of the same age, or some epidemiologic study that examines this specific cohort separately and can provide meaningful incidence data for the age group.

     

    Without knowing whether the age group has a higher prevalence than the population as a whole, your assumption of background incidence of 0.00036 in this age group could be way off.
    22 Jan 2013, 04:00 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Hi Doc
    That's correct, I did not lookup an exact background incidence number by the youth age cohort. That's because I did not need it. What is important in estimating the needed sample size is the effect size.

     

    The effect size was reported to be 7 to 13 times higher than the background rates for youth cohorts. This implies that the technical studies that the report was based on do indeed have access to the background rate from non-injected youth cohorts. Otherwise, they could not report the effect sizes. Those technical studies were published under peer review, so they must have had acceptable estimates of the background rate within the cohort groups. I did glance at some of the technical reports and noted that the 'risk time' was well within one year.

     

    I only did the quick and dirty power analysis to provide an estimate of what it would take in terms of sample size to detect a 10% effect within age cohorts. Based on my simple power analysis it's clear the clinical trial performed was not designed to pick up 10% or lower side effects. In hind sight, perhaps that should be reconsidered.
    22 Jan 2013, 06:36 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Re: Bird Flu research moratorium-update
    http://yhoo.it/10TF5Sl
    24 Jan 2013, 05:06 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): "BARDA Continues Novavax' Influenza Vaccine Programs Following In-Process Review"

     

    http://bit.ly/10NbFEy

     

    HardToLove
    24 Jan 2013, 08:13 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    an 24 (Reuters) - Novavax Inc :
    * Biomedical advanced research and development authority (barda) continues
    novavax' influenza vaccine programs following in-process review
    * Barda notified co that milestone decision has been made to continue contract
    for both seasonal,pandemic influenza programs
    * Source text
    * Further company coverage
    ((Bangalore Newsroom; +1 646 223 8780))
    For Reuters Top News page click the following link:
    24 Jan 2013, 08:18 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » January 24, 2013
    New norovirus strain linked to NZ death

     

    A new strain of the norovirus stomach bug that has hit New Zealand has been linked to a death in Northland. The Sydney 2012 norovirus strain was identified in Sydney last year, and is a combination of two strains that originated in Holland and Japan in about 2007. It is a new, highly infectious strain that can cause epidemics. It has health officials around the world concerned and 17 cases of the new strain have already been identified in New Zealand, including one death in Northland. http://tinyurl.com/aqu...
    24 Jan 2013, 06:21 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Alright something I took with me to Honduras and handed out might help all here. I call it "Doubleguns Brew".

     

    It is made with Colloidal silver 5000 ppm and Grapefruit seed extract (not grape seed extract). Mix it at 50/50 and keep in an amber or dark blue bottle. My label is below. It is awesome stuff and may help prevent folks from getting this crap that is going around. I would advise 30-50 drops twice a day for 3 days to start then go to maintenance mode (5 drops 4X day) while this crap is around. I was asked to get the recipe out while I was down in Honduras and never have yet so here it is. This seems the best place to put it.

     

    Doubleguns Brew--50/50 GSE/Colloidal Silver 5000ppm
    Antibiotic/fungal/viral-- 5 drops 4X daily
    Purify water 20-40 drops per gallon- wait 30 mins
    Prevent travelers diarrhea 5 drops 3X daily
    First aid--Apply directly to cuts, bites, blisters etc…
    Do not put in eyes only.

     

    This stuff will even work on athletes foot.

     

    Very bitter so mix with something to drink it down with. Water is not good because it just means more bitter liquid to swallow. GSE is very, very bitter but thats the medicine in it.
    24 Jan 2013, 07:54 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    can u buy ingredients anywhere ?
    24 Jan 2013, 08:01 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    This is where I buy my stuff

     

    GSE
    http://bit.ly/11V30jP

     

    SILVER
    http://bit.ly/10FgACL
    24 Jan 2013, 07:59 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Blackrock filed this today: They own over 5% of NVAX. I don't remember this, was it already posted ?

     

    Amount beneficially owned:

     

    8326166

     

    Percent of class

     

    5.63%
    30 Jan 2013, 05:45 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    LT: I haven't been following BR's holdings, so I'm no help there.

     

    HardToLove
    30 Jan 2013, 05:52 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Inovio being touted for it's synthetic flu vaccine....only in Phase I,
    Any thoughts ?
    http://seekingalpha.co...
    31 Jan 2013, 06:01 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    Sounds very promising on the technical side. There my only concern would be the rapid and varied mutations that a virus can exhibit. Is it possible that a mutation will render the sequence they have identified useless? I don't know. Does it take long to re-sequence?

     

    The article mentioned many competitors doing tri and quadra-valent vaccines. They didn't mention that (NVAX) has demonstrated effectiveness in the tri-valent and is looking at making the quadra-valent effective too. The first test of it yielded good results on three but came weak on the fourth, so they have to re-work that component.

     

    I think down the road a tie-in between NVAX's fast manufacturing process and Inovio's sequencing process might be good since both "build" product off a process of DNA sequencing.

     

    Having hung in for a long time with NVAX, I would expect Inovio might face a similar extended time-frame to market. So patience would be my requirement for entry into Inovio.

     

    HardToLove
    31 Jan 2013, 06:36 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Not mentioning NVAX much didn't bother me, cause he was hyping Inovio more than anything else.
    I agree that patience and watching is all for me at present.
    31 Jan 2013, 07:42 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    LT: I only mentioned the NVAX because he didn't remind that it was one more player developing the quadra-valent vaccine along with the others. Since this is a risk factor I felt it important that another was also in that space. He did mention they were doing a tri-valent, IIRC.

     

    HardToLove
    31 Jan 2013, 08:17 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Vical Announces Publication of Herpes Simplex Vaccine Guinea Pig Study Data http://tinyurl.com/ak9...
    4 Feb 2013, 06:34 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    definitely one to watch
    4 Feb 2013, 06:56 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Something big? I've seen before where news sometime is preceded by big trades. Today, after putzing around $1.76-$1.77 most of the day, two trades went off @ 14L32: $1.755x675K and $1.755x136.7K.

     

    I wonder if we'll get some more Phase x trial results for RSV or flu vaccine in the next couple days.

     

    HardToLove
    4 Feb 2013, 02:38 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): By 14:41 we had hit $1.85 and have now settled around $1.795.

     

    Hypothesis: the big buyer called his "friendly" broker/market-maker and said he wanted ~800K around $1.76.

     

    MM et al holds price down accumulating the blocks. Then in one of the "dark pool" times that NASDAQ provides throughout the day at their published times, the accumulated shares are passed to the recipient.

     

    HardToLove
    4 Feb 2013, 02:56 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I told you where I will appoint u for your next job ! I bet your correct.

     

    Nice find....I been watching it down in the $1.70's wondering when to buy more...? Looks like anytime now is good.
    4 Feb 2013, 03:29 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    LT: But this one was easy - recall that we had PR the 24th that said BARDA continued the contract. So it's only a matter of time from a BARDA positive decision on data presented until that data will become PR.

     

    I shamed my tin foil hat in this case. :-((

     

    HardToLove
    4 Feb 2013, 03:33 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I remember that, the stock soared to %2.20-2.40 then sold off down to $1.70.....it is so interesting how MM's can take a stock down with a big enough order.
    4 Feb 2013, 05:25 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    FYI: (NVAX) is running. I bought 3K @ $1.80 2/1 based on trend lines and the expected normal rise into options expiration week. ATM trading @ $1.87.

     

    Target ~$2.02-$2.07, based just on reversion to the mean, where I will likely short some $2 covered calls on a portion, garnering a nice premium.

     

    There's a *potential* resistance at $1.92 or so. The next ones that seems likely are a psychological $2.00 resistance and a prior resistance at $2.07 - never acted as support yet on a one-year chart.

     

    It may not be too late to make a trade, if interested, since we've seen no news (yet) and the *normal* high will occur Wed of next week.

     

    CAVEAT: Last month's high came 4 days earlier than normal and I don't know if it will repeat or not. Regardless, if entered here and then covered calls are sold one can do well even if no news appears in the next 8 days.

     

    MHO, caution and risk considerations suggested,
    HardToLove
    5 Feb 2013, 02:19 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    Nice move, HTL. I regret not adding NVAX last November, before flu season hit, knowing the BARDA phase two $ was soon coming...again.
    5 Feb 2013, 03:23 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Here's the news - although not what I expected. I guess they want to hold the details for the conference?

     

    These events do generally bring a pps increase, especially if they reveal new results from trials. Adding in the mention at the conference that BARDA extended the contract, and there might be a decent pps response ... if it hasn't already been priced in by the (suspected?) news leak. That big purchase of 800K may have been a set up to "sell the news" and take big profits in a very short time.

     

    I might need to try and re-evaluate my near-term target price. What to do, what to do ...

     

    "NOVAVAX to Present at the 15th Annual Bio CEO & Investor Conference"

     

    "... February 11th at 3:00pm. A live audio-only webcast link for the presentation can be accessed via the company website at http://www.novavax.com under Investor Info/Events".

     

    http://bit.ly/XqlfWU

     

    HardToLove
    7 Feb 2013, 08:17 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Behavior is changing from prior years. Don't know if it's long-term or an aberration.

     

    Anyway, right now it's trying to form a head & shoulders pattern. The neckline is currently at ~$1.74 and drops about $0.003/day. If pps penetrates this and confirms, expect a drop. Target would be first $1.68, using a reversal point, and then ~$1.50 using Bulkowski's "measure rule".

     

    I'm thinking the pattern won't complete because of the upcoming presentation. Regardless, I'll have some tight stops in place.

     

    HardToLove
    8 Feb 2013, 10:24 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    3:02 PM A genetically modified smallpox vaccine has been shown to shrink tumors in liver cancer patients and extends survival more than a year, a recent study found. The therapy, from closely held Jennerex, is called JX-594, or Pexa-Vec, and is currently being tested in people with advanced hepatocellular carcinoma. Treatment options for this advanced type of cancer are limited, and San Francisco-based Jennerex is competing with drug behemoths such as Amgen (AMGN -1.5%) and Merck (MRK +0.4%) in the space, as well as others such as Oncolytics Biotech (ONCY -5%) and Dendreon (DNDN -3.3%). Comment!
    11 Feb 2013, 03:54 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Schwab downgraded NVAX from C to D rating.
    11 Feb 2013, 05:01 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    1:46 PM Shares of Bristol-Myers (BMY -0.7%) slide after a federal judge rules a U.S. patent for its hepatitis B treatment Baraclude is invalid, saying there's clear and convincing evidence that a key claim in the patent is invalid due to obviousness. The ruling opens the door to Teva Pharmaceutical (TEVA +0.4%) selling a competing generic copy. BMY says it's disappointed in the ruling and plans to appeal. Comment! [Healthcare, On the Move]
    12 Feb 2013, 01:49 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Seth Klarman's firm Baupost Group recently filed an amended 13G with the SEC regarding its position in Idenix Pharmaceuticals (IDIX). Per the filing, Baupost Group now owns 18.48% of the company with 24,740,200 shares.

     

    This marks around a 106% increase in the number of shares they own since the end of the third quarter. The filing was made due to portfolio activity on January 31st.

     

    Per Google Finance, Idenix Pharmaceuticals "is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases with operations in the United States and Europe. The Company's research and development focus is on the treatment of hepatitis C virus (HCV)."
    13 Feb 2013, 06:05 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Took profits today as the behavior seems to have changed slightly and it was looking like $1.92 might be iffy. Exited at $1.87.

     

    Will re-enter somewhere at the next low.

     

    HardToLove
    13 Feb 2013, 10:41 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    Well, I should've stuck to my guns - a few minutes after my exit, volume came in and we hit my target of $0.92 at 11:55, a bit over an hour later. If I had used trailing stops, would've got an exit somewhere above $1.90 I think. But I have "issues" with exposing my hand while what I believe is the manipulation in the markets exists.

     

    Regardless, I wanted to fill you in, in case you're tracking (NVAX).

     

    Last month the high hit four days earlier than the normal Wed. of options expiration week. This month the move up started later and held several days around my $1,80 entry point instead of grinding up.

     

    There are *two* *potential* head and shoulder patterns that may complete and both necklines are at $1.78 and rising. A break below foretells bad ju-ju.

     

    Volume was very low in the A.M, so I got skittish when all things were considered.

     

    HardToLove
    14 Feb 2013, 07:58 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I expect you did the right thing, sometimes I have done that and it's like they are just waiting for me to exit and then they run the price up.

     

    I have no doubt they know our positions and only a power announcement can alter it. Manipulation does exist.
    14 Feb 2013, 08:25 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    OOPS: "target of $0.92" -->> "target of $1.92".

     

    HardToLove
    14 Feb 2013, 08:46 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    There was an announcement this week that a SAR's like virus spread human to human...I think 11 infected, 5 died. Sorry I don't have time to find the link.
    14 Feb 2013, 08:26 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    LT, here is the link for that.

     

    http://cbsn.ws/Zd2IEu
    14 Feb 2013, 10:56 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    thanks dg
    14 Feb 2013, 11:39 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Went long 10 (NVAX) $2 Mar. puts @ $0.25, delta already 77%, figuring the typical down trend as we exit options expiration *may* still be in play. This relys on the pps penetrating below those rising neckline support with a target of ~1.70 or so. That's *iffy* as I don't know which of the H & S is really the one in play.

     

    Could be a tad more or less, but should be a reasonable gain, sans any news, for na estimated ~2 week play.

     

    xxx <<-- fingers crossed and small risk small taken, small reward expected. Could be combined with a small buy of the underlying if price is low enough and I'd like to add some of those to long-term holdings.

     

    HardToLove
    14 Feb 2013, 09:58 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » There were some strange goings on at the close on VICL yesterday. The last two bids were way higher than the preceding bids. The stock closed at 3.39 when most of the preceding bids were around 3.32. It could just be a fat finger, but two fat fingers on two back to back smaller buys with slightly different prices?

     

    Is someone trying to keep the average close above a certain level? I would normally think dilution here, but they have cash on hand...
    14 Feb 2013, 12:18 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    http://bit.ly/15rz8M3

     

    more on the SARS like virus and it's tx.
    19 Feb 2013, 05:02 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    http://bit.ly/11SfMAF

     

    New drug, but simple cure for Malaria which infects 200 million & kills 600,000/year. I would think it could be done in much less time than they preidict.
    19 Feb 2013, 05:05 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Sounds very promising. It would change a lot of lives for the better.
    19 Feb 2013, 01:35 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Amazing what the 20th century accomplished in public health and vaccinations:

     

    http://onforb.es/Vue8jG
    19 Feb 2013, 06:04 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I noticed Zogenix ZGNX drifting lower, here is why....the FDA is delaying it's letter due Mar.1 by a few weeks. I would still think they get approval...risky though.
    http://bit.ly/YyHQkj
    26 Feb 2013, 08:16 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): "Novavax to Report 2012 Fourth-Quarter and Year-End Financial Results on March 1, 2013"

     

    http://bit.ly/Whvva6

     

    HardToLove
    27 Feb 2013, 06:56 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Zogenix, Inc. (NASDAQ: ZGNX) sees sharp upside despite a FDA PDUFA delay on Zohydro.
    After the close, Zogenix said it been informed by the FDA that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for ZohydroTM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013.
    Wells Fargo analyst Michael Tong comments: "FDA to miss Zohydro ERs 3/1/2013 PDUFA date, but the delay is likely short (weeks). We continue to believe the odds for eventual approval are high. We speculate FDA is dealing with issues of access and potential misuse. At the current valuation, we view the reward/risk profile of ZGNX shares as skewed toward the reward side. We see 20% downside potential on a negative FDA decision but potentially 100%+ upside on a positive decision." The firm maintained an Outperform and $3.50-$4.00 price target.
    Analysts view the news as positive.
    Shares of ZGNX are up 46 percent.
    News Provided by Acquire Media Corporation
    27 Feb 2013, 01:30 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Thanks for that news LT !
    27 Feb 2013, 02:16 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    heres one to watch....theres alot more than 35 m people with it.

     

    6:17 PM Anacor Pharmaceuticals (ANAC) announces positive preliminary results from the second of two Phase 3 trials of tavaborole, a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35M people in the U.S. Results from the first Phase 3 trial were announced on January 29, and in both studies, achieved statistically significant and clinically meaningful results on all primary and secondary endpoints. Shares +3.2% AH. [Healthcare, On the Move] Comment!
    28 Feb 2013, 06:45 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): "Novavax Reports Fourth Quarter and Year-End 2012 Financial Results"

     

    http://bit.ly/148OuBu

     

    Loss ($0.06)/share vs. estimates of ($0.04)/share. I've not checked to see if either item includes/excludes items yet. For the year, ($0.22)/share vs. est. ($0.20)/share.

     

    HardToLove
    1 Mar 2013, 08:07 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Details from briefing.com (I can't access via link - sorry). My first post used estimates from consensus on ETrade.

     

    Misses revs by ($0.01)/share vs. Capital IQ consensus of ($0.05), misses on top line at YoY (20.7%) to $4.6MM vs $7.02MM consensus.

     

    Everything else as in the link above.

     

    Let's see if my long puts position pays off now.

     

    HardToLove
    1 Mar 2013, 08:38 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    I heard the presentation this morning--their programs are all going well with additional trials scheduled for different age groups.
    They were told by BARDA that payments shouldn't be impacted by sequestration.
    They don't disclose enough regarding what to expect regarding their burn rate, imo. That is their policy but I don't think it is fair to their investors. One thing they said which impressed me is the breadth of interest in their products by other companies. I came away very optimistic.
    1 Mar 2013, 02:33 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    O.G.: Ditto here - I heard nothing that reduces my long-term optimism. And one thing that I hadn't heard much of recently, the rabies vaccine for India, sounded closer to realization than I had been imagining.

     

    HardToLove
    1 Mar 2013, 02:47 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    is it a buy now?
    1 Mar 2013, 07:03 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    I don't think so. It's a hold, imo. There is no profit in sight, more spending promised, and no clues regarding partnerships and raising funds.So, quite possibly, there is only dilution and/or greater debt coming for the foreseeable future.
    2 Mar 2013, 12:29 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    LT: I agree w/O.G. I just keep playing the options for now to make a little $, reducing opportunity cost. Just keep the long times needed for the various trials to finally reach approval in mind. I keep my starter positions is all for now.

     

    HardToLove
    2 Mar 2013, 06:26 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    O.G.: "... no clues regarding partnerships and raising funds"

     

    "we've entered into important partnerships, which strengthened the company's balance sheet, distributing our cash all the way to 2015".

     

    http://seekingalpha.co...

     

    Last paragraph on page 1.

     

    If I interpret this correctly, is this a clue that we shouldn't expect any capital raises until late 2014? If so, even that might not be needed as one or more of the products might generate additional revenue-generating partnerships as the various trials progress.

     

    Right now, I'm wondering just how close the rabies vaccine for India might be. With it supposedly such a huge problem there, and CBP (?) working on it for a long while now ...

     

    HardToLove
    2 Mar 2013, 10:12 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    "... and CBP (?) working on it for a long while..."

     

    CBP->CPLB

     

    HardToLove
    2 Mar 2013, 10:31 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I liked the risk discovery question from Greg Wade of Wedbush Securities as to whether NVAX is using Squalene as an adjuvant in some of their trials. Squalene has been implicated in the onset of narcolepsy in Europe among young people getting the H1N1 vaccine shot.

     

    I felt the response from Dr. Fries - Vice President of Clinical and Medical Affairs -did not defuse the issue because Fries responded by specifically cautioning about leaping to any conclusions about Squalene. I felt that response suggested that they have been using Squalene as an adjuvant in their clinical trials. If that is the case, I would consider that as negative news. No matter how the investigation turns out, Squalene is under investigation, and clearing it is going to take a good deal of time. If NVAX was not using Squalene they should have just said so. If they are using Squalene as an adjuvant in their trials, I would think those trials would need to be replicated using another adjuvant - more delays and more costs.

     

    They say they are in the strongest financial position ever with the available resources to move their programs forward into 2015. That's great, but loses have also increased. Their burn rate increased from monthly $3 M to $4.3 M from 2011 to 2012. That's a 43.3% increase. And they say their costs are going to increase in 2013. If they increase at the same rate as 2011 to 2012, the burn rate goes to $6.2 M per month, or about $74 M per year. If their burn rate increases by half of the 43.3% increase, the burn rate goes to $5.2 M per month or about $63 M per year. Cash (or equivalents) on hand at the end of 2012 was about $50 M. I agree with OG's feelings about their lack of guidance on their projected burn rate. I think lack of guidance on burn rate is suggestive.

     

    One of the reasons costs are going up is because they have a lot of irons in the fire. Another reason is because BARDA payments are back loaded. The clinical data looks promising, and there is the possibility of further partnerships. But I wish I had a better read on their timeline.
    1 Mar 2013, 10:12 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    FPA: Reading the CC transcript, I noted "... of our RSV vaccine candidate, with and without aluminum phosphate as an adjuvant".

     

    I don't know if this has any implications for the flu-side trials, but got to wondering if this might suggest, regardless of the hemming and hawing, that they are using some adjuvant other than Squalene. The thought arises only because I know folks tend to stick with what they used elsewhere and with which they are already familiar.

     

    On page 2 about 3/4 of the way down the first paragraph.

     

    http://seekingalpha.co...

     

    I also had the thought that his hedging *might* be because they want to be in position to use Squalene in the future if it turns out to be not the culprit. Bad-mouthing it now would effectively close that door.

     

    Thought three is that a scientist wants to defer conclusions until all the data is in, especially where complicated interactions, difficult to isolate, are involved.

     

    HardToLove
    2 Mar 2013, 10:02 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I argue that the key point is whether ANY of their current products/ trials have exposure to Squalene.... Given the current negative attention directed at Squalene, I think it would be quite risky to use it for any new products/ trials and existing products until it's given a clean bill of health. So by not providing a denial on current Squalene exposure for all their products, risk exposure will remain unknown for shareholders. That potential risk exposure issue could have been buried if Dr. Fries had been able to provide a denial.

     

    The Squalene issue raises experimental design issues for ALL manufacturers running trials of products designated to use Squalene, not just NVAX. For example, I doubt a manufacturer would be able to proceed on an advanced multi-stage trial if they were forced to change one of the ingredients in use during previous stages.
    3 Mar 2013, 12:41 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Having read the comments together with the FDA website on squalene
    It makes no business sense to perform trials on people using an adjuvant that isn't approved in the USA. Wouldn't that be an insane liability? Stay away from NVAX, Rattie, they may be looking for a few good rats to test their products with squalene adjuvant! Cyber wink.
    3 Mar 2013, 02:17 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    The timeline is at least 4-5 years, imo. They are still a long way off from bringing these products to market.
    Re: Squalene. Are they crossing the line between protecting proprietary information and disclosing material facts to shareholders?
    That has happened in the past, in my opinion. (Before Stanley Erck).It was one of the reasons I was so excited to hear about their management changes at the time.
    HTL, I would be surprised if your puts don't pan out!
    2 Mar 2013, 12:28 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    O.G.: Things may not be quite so beak. From page two of the transcript, regarding the RSV studies, which will be a big deal if and when ...

     

    ".. We anticipate reporting the results from the trial through Day 56 observations in April".

     

    If results are positive, this could be a price "popper". And

     

    "Although PATH's initial funding was just for this trial, our expectation is that PATH will continue to support the ongoing development of our RSV vaccine candidate for maternal immunization. As part of our agreement, PATH can elect to continue to collaborate on additional phases to develop the vaccine for maternal immunization, potentially funding 50% of Novavax's external clinical development cost through to licensure".

     

    This suggests that capital raise might be even further deferred, *unless* they included this assumption into the "through 2015" estimate.

     

    HardToLove
    2 Mar 2013, 10:19 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): Bottom of page two (emphasis mine)

     

    http://seekingalpha.co...

     

    "First, we met our primary objectives, which were to demonstrate that all vaccine adjuvant combinations and unadjuvanted vaccines have a suitable safety profile that generated robust immune responses. Importantly, the unadjuvanted vaccines have 45 micrograms per dose induced immune responses that EXCEEDED THE FDA CRITERIA FOR APPROVAL AFTER 2 DOSES, an UNPRECEDENTED RESULT COMPARED TO THE OTHER UNADJUVANTED H5N1 VACCINES. In addition, the administration of the unadjuvanted VLP vaccine formulations resulted in high antivirus responses in significant antigen dose parity, down even to the lowest dose of 3.75 micrograms, at which over 90% of the subjects developed immune responses considered likely to be protected. We also saw activity which suggests that our vaccine may be PROTECTED EVEN WHEN THE VACCINE'S STRAIN DID NOT PERFECTLY MATCH the pandemic virus strain, which is an IMPORTANT CONSIDERATION IN THE EMERGING RESPONSE TO AN ANTIDOTE".

     

    HardToLove
    2 Mar 2013, 10:26 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    THANK YOU for highlighting those statements, HTL.
    2 Mar 2013, 11:28 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Here is a 2009 article about Squalene and it's impact on Gulf War Vets. I do not know if the source of this article is reliable. The author is definitely anti-vaccine. However, Squalene is an oil based adjuvant, which I think ( but I'm not certain)
    does not contain
    aluminum phosphate. At any rate, here is this background information, for what it is worth: THe article calls Squalene The Swine FLu Vaccine's dirty little secret exposed. Please note that the swine flu vaccines approved in the USA did not contain squalene in 2009.
    http://bit.ly/XNBn60.
    2 Mar 2013, 11:50 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    O.G.: Thank you - a very informative read. I think the quotes from authoritative sources and studies at least lend some credence to the concerns expressed.

     

    I'd sure like to find out if squalene is in use here.

     

    Those drug companies are heavyweights and I wouldn't be surprised to find out they've entered our market with that adjuvant.

     

    Thank you!
    HrdToLove
    2 Mar 2013, 12:07 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    OG, An article I think I posted before about adjuvants and some on squalene. Bad stuff and it covers the military also.

     

    http://bit.ly/YfEsLm
    7 Mar 2013, 06:07 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Per FDA ( a much better read than the last article, imo)

     

    http://1.usa.gov/ZagEe0

     

    If you wanted to use squalene as an adjwant (to boost immune responses) you would have to multiply the
    amount of squalene found by the FDA about 1 million times, as well as change it from a simple liquid (its natural
    state) to an emulsion. An emulsion is a stable suspension of tiny droplets, like an oil-and-vinegar mixture that
    doesn’t separate. This double difference is like the difference between a teaspoon of oil and 2,000 pounds of
    mayonnaise. (If you emulsify oil with eggs, you get mayonnaise.]
    Squalene in the form of an emulsion (emulsified squalene, such as an adjuvant called MF59) has been added
    as an adjuvant to some investigational vaccines in the U.S. (Burdin et al., 2004)
    There is no squaiene adjuvant in any US-licensed vaccine.
    Whatever the arguments for or against squalene as a vaccine adjuvant, the fact is that none of the anthrax
    vaccine administered to U.S. troops contained squaiene as an adjuvant. Based on manufacturing records, FDA
    can verify that no squalene was added to any vaccine fonnulatiin used during the Gulf War. This includes the
    anthrax vaccine. To date, the FDA has licensed, and US manufacturers have used, only aluminum salts (for
    example, aluminum hydroxide, aluminum phosphate, aluminum potassium sulfate) as adjuvants.
    8) What do we know about the European influenza vaccine that uses MF59 (an adjuvant containing
    squalene).
    In 1997, European health agencies approved emulsified squalene (with influenza virus in the center of each
    droplet) for use as an adjuvant in an influenza vaccine (Fluad, Chiron Corporation, Marburg, Germany, and
    Siena, Italy, http://bit.ly/Z58EJT ; Sesardic & Dobbelaer,
    2004). Some clinicians consider influenza vaccine with MF59 adjuvant to be better able to induce immunity in
    elderly people (Banzhoff et al, 2003).
    To make this influenza vaccine work, researchers needed a squalene concentration of 1.95% (about 2 parts per
    hundred or 20 million parts per billion) to boost the immune response. This squalene had to be in the form of an
    emulsion (a mixture of tiny droplets) to be recognized by the Immune system. Squaiene in its oily state is
    naturally present inside the human body.
    Tens of millions of doses of this European influenza vaccine have been
    administered safely since 1997.
    2 Mar 2013, 12:27 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    Thanks O.G.!

     

    HardToLove
    EDIT: the second link gave me a 404 not found.
    2 Mar 2013, 12:42 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I expect this is also part of NVAX declining pps along with a crappy adjuvant.

     

    http://reut.rs/XNZZPj
    http://bit.ly/YnwOl8
    - Treatment with highest dosing regimen of VX-787 reduced viral shedding by 94
    percent versus placebo; Duration of flu symptoms were reduced by nearly half -
    - VX-787 is an investigational new class of medicine designed to directly
    inhibit replication of the influenza virus -
    CAMBRIDGE, Mass.--(Business Wire)--
    Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that
    treatment with VX-787 in a Phase 2 influenza challenge study resulted in
    statistically significant improvements in viral and clinical measurements of
    infection. VX-787 is an investigational new class of medicine for the treatment
    of influenza and is designed to directly inhibit replication of the virus. The
    study met its primary endpoint, and showed a statistically significant decrease
    in the amount of virus in nasal secretions (viral shedding) over the seven-day
    study period. In addition, at the highest dosing regimen evaluated in the study,
    there was a statistically significant reduction in the severity and duration of
    influenza-like symptoms. People in this dose group experienced influenza-like
    symptoms for a median of 1.9 days, compared to 3.7 days in the placebo group. In
    addition, 93 percent of people in this dose group showed no clinical symptoms of
    influenza after three days of treatment, compared to 41 percent of people in the
    placebo group. In this study, VX-787 was generally well-tolerated, with no
    adverse events leading to discontinuation. Based on these data, Vertex will
    explore collaborative opportunities to support further development of VX-787.
    "There is an urgent need for new medicines targeting influenza that work more
    quickly, address resistant and pandemic strains, and are effective when taken
    more than two days after symptoms appear," said Chris Wright, M.D., Ph.D.,
    Vertex's Senior Vice President, Global Medicines Development and Medical
    Affairs. "Further development of VX-787 may offer an opportunity to address
    these needs. The data from this proof-of-concept study validate VX-787`s new
    mechanism of action, and underscore its potential to significantly reduce the
    severity and duration of influenza."
    About the Phase 2a Study
    This double-blind, randomized, placebo-controlled Phase 2a study of VX-787
    enrolled and dosed 104 healthy people (72 in the VX-787 arms; 32 in the placebo
    arm) ages 18 to 45 who volunteered to be experimentally exposed to an attenuated
    form of live H3N2 influenza A virus. H3N2 is a common type of influenza virus,
    and was the most common type observed in the 2012/2013 influenza season in the
    United States. The study evaluated four dosing regimens of VX-787 given
    once-daily (QD) for five days beginning 24 hours after infection with flu virus.
    This was followed by an additional two days of observation. The study was
    conducted in a controlled quarantine facility with participants under close
    observation.
    The primary objective of this study was to determine the effect of VX-787 on
    levels of the influenza virus by measuring the total area under the curve of
    viral titers (quantity of the virus shed in nasal secretions) over time. Viral
    shedding is a validated marker for assessing antiviral agents in
    proof-of-concept clinical studies in influenza. Higher total area under the
    curve (AUC) indicates greater shedding of the influenza virus from the upper
    respiratory tract, whereas lower total AUC indicates inhibition of, or
    decreased, viral shedding.
    Secondary objectives of the study included safety and tolerability, as well as
    duration and severity of clinical symptoms. In the study, only people who
    developed influenza infection after exposure, as measured by detectable virus in
    nasal secretions or a pre-defined antibody response, were included in the
    efficacy analysis, whereas all study participants were included in the safety
    analysis. Of the 72 patients enrolled across the VX-787 treatment arms, 52
    developed influenza infection. Of 32 patients enrolled in the placebo arm, 22
    developed influenza infection.
    Efficacy Data
    Primary Endpoint: Across the VX-787 doses studied, a statistically significant
    dose response in reduction in viral shedding AUC was observed (p=0.036). In
    addition, over the seven days of observation, the 14 people in the highest dose
    group showed a total median AUC of 0.4 log10 virus compared to the 22 people who
    received placebo, who showed a total median AUC of 5.9 log10 virus, a difference
    that was statistically significant. These median AUC values reflect a 94 percent
    reduction in the amount of virus shed during the study for people treated with
    the highest dosing regimen of VX-787 compared to placebo.
    Secondary Endpoints: In addition to reductions in total viral AUC, treatment
    with VX-787 in the highest dose group also resulted in statistically significant
    improvements in multiple clinical measures of influenza. People in this group
    experienced influenza-like symptoms for a median duration of 1.9 days, compared
    to 3.7 days for those who received placebo. In addition, there was a
    statistically significant decrease in the severity of influenza-like symptoms,
    as measured by AUC and peak severity of symptoms reported by participants in the
    study. Participants graded seven influenza-like symptoms on a scale of 0 to 3;
    this was summed to obtain a symptom severity score (maximum symptom severity
    score of 21.)
    Influenza-Like Symptoms Placebo (n=22) 1,200 mg / 600 mg* (n=14)
    Peak (mean; severity score) 3.4 1.4**
    Duration (median; days) 3.7 1.9**
    AUC (median; severity score over 7 days) 4.1 1.8**
    * First dose was 1,200 mg for one day, subsequent doses were 600 mg QD for four days
    ** Statistically significant; p<0.05
    Safety Data
    In this study, VX-787 was generally well-tolerated, and all participants
    completed treatment. There were no serious adverse events or adverse events that
    led to discontinuation of treatment. Overall, the most frequently reported class
    of adverse events in the VX-787 and placebo arms were those typically associated
    with influenza-like illness. In the development program to date, VX-787 has been
    dosed in approximately 170 people. The highest single dose given was 1,600 mg,
    and the longest duration of dosing was 800 mg QD for 10 days. In these studies,
    there were no serious adverse events, and no adverse events that led to
    treatment discontinuation.
    About VX-787
    VX-787 is an investigational medicine being developed by Vertex that is designed
    to directly inhibit replication of influenza A, including recent H1 (pandemic)
    and H5 (avian) influenza strains, based on in-vitro data. VX-787's mechanism
    represents a new class of potential medicines for the treatment of influenza,
    distinct from neuraminidase inhibitors, the current standard of care for the
    treatment of influenza. VX-787 is intended to provide a rapid onset of action
    and an expanded treatment window. VX-787, which was discovered by Vertex
    scientists, underscores the Company`s expertise in antiviral drug development,
    beginning with early research in HIV and more recently in hepatitis C. Vertex
    has worldwide rights to develop and commercialize VX-787.
    About Influenza
    Each year in the U.S., more people die from influenza than die from HIV/AIDS.i
    Often called "the flu," seasonal influenza is caused by influenza viruses, which
    infect the respiratory tract.ii The flu can result in seasonal epidemicsiii and
    can produce severe disease and high mortality in certain populations, such as
    the elderly.iv Each year, on average 5 to 20 percent of the U.S. population gets
    the fluv resulting in more than 200,000 flu-related hospitalizations and 36,000
    deaths.vi The overall national economic burden of influenza-attributable illness
    for adults is $83.3 billion.vi Direct medical costs for influenza in adults
    totaled $8.7 billion including $4.5 billion for adult hospitalizations resulting
    from influenza-attributable illness.vi The treatment of the flu consists of
    antiviral medications that have been shown in clinical studies to shorten the
    disease and reduce the severity of symptoms if taken within two days of
    infection.vii There is a significant need for new medicines targeting flu that
    provide a wider treatment window, greater efficacy and faster onset of action.
    About Vertex
    Vertex creates new possibilities in medicine. Our team discovers, develops and
    commercializes innovative therapies so people with serious diseases can lead
    better lives.
    Vertex scientists and our collaborators are working on new medicines to cure or
    significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid
    arthritis and other life-threatening diseases.
    4 Mar 2013, 08:39 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    ZIOPHARM - phase 3 trial results due at end of month

     

    http://bit.ly/WDmNOf
    4 Mar 2013, 08:47 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    March 5 (Reuters) - Zogenix Inc :
    * Brinson Patrick starts with market outperform rating; price target of $5 -
    benzinga.com
    5 Mar 2013, 08:40 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » VICL popped by more than 15% on Wednesday, March 6.

     

    I can't find any news other than VICL presented at Cowen and Company 33rd Annual Health Care Conference on Wednesday morning. There were some big block trades made, so it appears some people liked what they heard...
    7 Mar 2013, 05:53 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    FPA: YowzaH! That's good - you still long, right?

     

    HardToLove
    7 Mar 2013, 06:02 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Yes... I bought last month because I liked the look of their pipeline timing. http://tinyurl.com/a8e...

     

    Normally, I would be very tempted to take profits if it hits $4.5, but the big player purchases yesterday on the open market at premium prices definitely got my attention. Someone seemed to be in a hurry... and reports on three of the products in their pipeline are in preparation. I think that is suggestive.
    7 Mar 2013, 06:35 AM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    Congrats, FPA!

     

    ####

     

    'Nightmare' bacteria spreading in U.S. hospitals, nursing homes: CDC

     

    http://on-msn.com/YPo0kX
    7 Mar 2013, 02:17 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Thanks Maya... it dropped over 5% today... so quite a few people took the opportunity to take profits.
    7 Mar 2013, 02:32 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Long read, but good info on many biotech's...NVAX mentioned at end.
    http://seekingalpha.co...
    8 Mar 2013, 08:15 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Thanks, LT.

     

    The article put CYTK on my radar. Their phase II drug, tirasemtiv, looks very promising.
    8 Mar 2013, 10:53 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX): "Novavax, CPLB and ICGEB Collaboration Honored for Malaria Vaccine Progress at Vaccine World Summit India 2013"

     

    http://bit.ly/XZSV0W

     

    I'd forgotten about the malaria effort.

     

    HardToLove
    8 Mar 2013, 09:44 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    you're slipping ! lol
    8 Mar 2013, 10:12 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » The latest info on the number of dead pigs found floating in Shanghai's water supply (Huangpu River) is 6,000 and seems to be rapidly climbing. The claim is the pigs died of cold weather.

     

    However, people flinging 6,000 dead pigs into a river that serves as someone elses water supply is suggestive that the pigs were infected and people did not want to burry them on their farms. The Pork supply and cost of that supply are a big deal in China...

     

    Meanwhile, you have 6,000 decomposing pigs floating in your water supply... would you want your family to drink that water? http://tinyurl.com/ak2...
    12 Mar 2013, 04:35 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    Let me review my "enemies list" so I can send them samples! ;-))

     

    Not really funny though.

     

    HardToLove
    12 Mar 2013, 05:08 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » From Shanghai Daily: Around 50 pig carcasses were today discovered in the Hubei river, a tributary of the Yangtze River. Some of the bodies were highly decomposed. The news has attracted much public attention as it follows the discovery of thousands of dead pigs in Shanghai's Huangpu River, a branch of the Yangtze. The media in China is carefully controlled, yet all these reports?? http://tinyurl.com/a7g...
    ---
    I was looking at this from the perspective of a public health issue; however, the Chinese pork industry is a primary source of food for a vast majority of China's population.

     

    Some Questions:
    Is it disease or was it cold weather that's killed the pigs?

     

    Is the fact that they were not buried an indication of the scale of the die-off?

     

    If the pigs died from cold weather, why were the pigs not butchered and sold as meat? Logistical issues, or were some sold as meat?

     

    Irrespective of what killed the pigs, what is the public health impact of having thousands of rotting pigs thrown in rivers that serve as downstream water sources for millions.

     

    If the pigs died of disease, could the disease spread to animals feeding on the dead pigs? Are the dead pigs a threat to the food chain?

     

    If they don't care about possible public health issues associated with throwing thousands of rotting pigs in a river that serves as a downstream water source for millions, what else is getting discharged into those water supply rivers?

     

    Does this signal a significant die-off in the Chinese pork industry, and if so, what is going to happen to the cost of pork?
    13 Mar 2013, 08:54 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    FPA, this is a very interesting situation. If this is a disease that spreads, then pork skyrockets. I am still appalled at whoever throwing the pigs in the river to start with.
    It raises my vivid imagination to the level that the disease is more serious than we imagine and that a quarantine would involve a much much larger population of hogs. That is the cover up IMO.
    13 Mar 2013, 09:20 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I am thinking cover up as well LT... I know China is reporting increases in food prices in January and February... I wonder if their pig herds have become infected with a wasting disease and had to be culled... chucking thousands of rotting pigs into a river? That speaks volumes about public health control systems.
    13 Mar 2013, 09:36 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I don't think the Chinese gov't would contaminate drinking water. They already have a major problem with the main rivers being contaminated to the point of maybe NOT EVER being to clean the water for human consumption.

     

    I think this is some large producer that doesn't want his entire herd quarantined or destroyed, pushing him into bankruptcy.
    13 Mar 2013, 09:49 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I wonder....

     

    Jan 9 2013 - Foot-and-Mouth Disease emerges in China
    http://tinyurl.com/b4j...

     

    Nov 2012 - China reports small outbreak of foot-and-mouth disease http://tinyurl.com/b4e...

     

    Mar 1 2013, reports an outbreak of FMD in swine. Location Guangdong. The event started on 18 Feb 2013.
    http://tinyurl.com/bjc...
    13 Mar 2013, 10:20 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    FPA: I bet you found the source!

     

    HardToLove
    13 Mar 2013, 10:48 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Tracing the location of those three reports of Foot and Mouth Disease, in Dalian City of Liaoning, Guangdong, and Guangyuan, they are at the opposite ends of the country from Shanghai, according to Google maps. Sort of like Idaho, Texas, and Maine compared to DC area, geographically. The reports variously indicate many hundreds of pigs being destroyed due to the disease.

     

    It appears to me that this represents an epidemic that has spread across the country, and could account for the dumping of dead pigs in Shanghai area.
    13 Mar 2013, 10:53 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Yes, I agree with your interpretation ... I think it's wide spread and it started late last year.

     

    I interpret dumping dead pigs into the river as an act of desperation. So what could be the source of the desperation and who was desperate? I don't see the government telling people to throw dead pigs in the river. I suspect the pig farmers were tossing their dead pigs in the river, in the dead of the night, like toxic dumpers. My guess is the pig farmers were afraid that if the health authorities found out what the pigs died from, it would cause their herds to be destroyed. I know they found some of the pigs had porcine circovirus, but you can safely eat pigs that have that virus, so I doubt health authorities would cull a herd for that. But they would cull a herd for foot and mouth. And if God forbid it was Anthrax, they would probably cull herds in an entire province.
    13 Mar 2013, 11:28 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Pork prices have plunged here in the states. Maybe this will provide some support for prices here now along with the price of beef. Might be having an effect already.

     

    http://bit.ly/YbcZeQ
    13 Mar 2013, 02:15 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    oBAMacare will likely rise insurance costs 20 to 100% next year (I could be paying as much as $10,000 next year for health insurance. Insane!):

     

    http://on-msn.com/13WlRMB

     

    Was reading on another thread that Five Guys Burgers and Fries is going to have to change their name to Four Guys Burgers and Fries, as one of the Guys is going to get laid off.

     

    ####

     

    FPA: Wild pig news going on there in China. Scary.
    13 Mar 2013, 03:38 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I am already paying $7200/yr, before Obamacare was mentioned. so that isn't the reason. We are just hitting the age that we notice how bad it's been all along.

     

    Just wait tip 60-65 y/o its $1500/mo
    13 Mar 2013, 05:31 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I don't know what they are going to do about health care costs... They are getting insane. The doctors are having a hard time too... It seems they want to force everyone into an HMO, or something like the UKs socialized medicine system.
    13 Mar 2013, 06:14 PM Reply Like
  • DRich
    , contributor
    Comments (4543) | Send Message
     
    We should wish we would get something as good as the UK system or better the Swiss system.
    13 Mar 2013, 06:40 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    FPA: A couple of years ago, I tried to increase my coverage, meaning I was willing to pay more for better coverage. I mainly wanted to get my plan from covering $600/day for hospital room coverage, up to $6000/day, which is about how much the local hospitals charge for staying a night; with an IV, crappy food, a heart monitor, and a nurse or two checking in every couple of hours.

     

    There was no way the insurance company would even broach the subject, as Obamacare ramifications had yet to be sorted out.

     

    What burns my butt is that Voldemorte is both raising the minimum wage, plus forcing small businesses to make sure their employees have insurance. What's crazier, it that Obamacare is targeting the age bracket of those who need health insurance the least, the 21 to 29 years olds, who could be using those monies to maybe buy a starter home.

     

    The only mandatory insurance I would favor for that age group would be catastrophic insurance.

     

    This is a double whammy that really hurts the top employers in the US do what they do best for our economy; create jobs.

     

    Sorry FPA for ranting, and clogging up your thread.
    13 Mar 2013, 06:50 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I totally agree Maya... Young working people, that have the least need for insurance, are being forced to buy it. I started my first business in my mid twenties... It was run on a shoestring. I would not have been able to do that with the new rules on insurance. How many small businesses, that form the core of American innovativeness, end up not being created because people can't afford to start them?
    13 Mar 2013, 07:56 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    FPA: I couldn't imagine the pressures restaurant owners like I used to be are under. So glad I'm out of that racket.

     

    About three weeks ago, my chef pal and I consulted a couple of nice young guys who want to open up a new concept. I fear for them. Especially because their prospectus was only three pages long; no performa, and a minimal understanding of what product they wanted to bring forth, how to negotiate a lease, how to attract angel investors, to lease or not lease equipment, etc. All they came up with was, "Healthy fast food."

     

    I recall asking them what they targeted for food cost, and labor cost. Pretty much no idea. Yikes!

     

    Right now I am not looking to invest in any restaurant concept, even my buddy's fantastically successful Bravo/Brio (BBRG).
    13 Mar 2013, 08:55 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I am a retired critical care RN, and let me tell you the cost of healthcare was high way before Obamacare....your giving something good a bad wrap.
    Insurance works by spreading the cost out over many....you can't just insure the sick and elderly ... it won't work and that's the corner the insurance companies got backed into. No one was buying insurance but the old, and sick.

     

    In my unit, the cost was $10,000 / day. For the room, monitor, and my service. All supplies and tests were extra.

     

    And....we got lot's of young people too, hyperglycemia for diabetics with their first onset, Children under 18 with MS, muscular dystrophy, and many many more, not to mention trauma from a car wreck or injury. Who do you think pays the bill when they come in "self pay" and walk out with a $300,000 bill ?

     

    The hospital writes it off, and charges you a bunch more to cover it.

     

    IF, you get sick without insurance....you are bankrupt. 90% of all people are headed that way without it. Including everyone here reading this. You may have that "coat of armor" that it won't happen to me, but it will IF you live long enough. and .... you do not have enough money to self pay for it. period.

     

    Maya, I will give you a hint, get a comprehensive Major Medical plan , Not a daily limit. Trust me, they are glad to pay the daily rate....because they may not cover anything else.
    13 Mar 2013, 09:41 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    LT: Thanks for the hint, but I already have a comprehensive major medical plan.

     

    I agree, health care was already way too high before Obamacare. Cost me and my insurance company over $36,000 to have my appendix removed, and most of that was just for a room for four nights ~ $20,000! For a freaking room!

     

    What's it going to cost now, $70,000?

     

    My point is that if someone lives to be 21 years old, is healthy, the accuary tables state that a huge percentage of those healthy will not need any significant medical care until well after 29 years old. My opinion is that forcing these youngsters to have expensive insurance is counterintuitive to what our constitution is all about. Especially if it reduces or prevents youngsters from starting up a new business, buying a house, or paying down a college loan.

     

    There are exceptions, though, and that's why I am pro catastrophic insurance coverage.

     

    Risks and choices are what make America great. But Obamacare is targeting the poor and the middle class, as well as small businesses; exactly opposite of what he has been stating/platforming all along, that he wants to help the poor and the middle class, and small businesses.

     

    Quite the opposite is what he is doing.
    13 Mar 2013, 10:04 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Refuse to allow hospitals to charge ridiculous amounts for services and the problem with the uninsured goes away. Hospitals are presently spreading the wealth through health care. If hospitals no longer take you for free you will soon buy health care insurance.

     

    When healthcare is free a large number of people will NEVER buy insurance. Insurance companys would sell a lot more policys if hospitals did not charge so much because the policys would be cheaper since the coverage cost would be cheaper. We are simply shooting ourselves in the foot here by manipulating the market by charging higher costs to the insured to offer free service to the uninsured. Once we make the insurance affordable everyone who works can buy it or thier employer can buy it. The rest remain on Medicaid.

     

    Free health care is the problem. Reminds me of the saying " Why buy the cow if the milk is free."
    14 Mar 2013, 03:32 PM Reply Like
  • Mercy Jimenez
    , contributor
    Comments (2021) | Send Message
     
    Very well said DG. But you are being way too rational for the political and lobbying crowd. In other words your proposal would require too many tradeoffs $$ for the current beneficiaries of today's health care system.
    mj
    15 Mar 2013, 11:01 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Mercy, that is unfortunately the fly in the ointment.
    15 Mar 2013, 04:45 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    The doctors are having a hard time too

     

    doctors are struggling....when hospitals sorta took over health care, they destroyed the AMA sorta like destroying a union. They pay Doctors very little. They bribed the gov't into paying them all the money on medicare/medicaid....for example a surgeon makes $80 for cholesysectomy (removing a gall bladder) laproscopically. The hospital gets $5000/hour for the Surgery room.
    15 Mar 2013, 05:12 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    LT: And over the decades they are managing to make a monopoly too, at least where I live. Latest move is regionally-owned by a single corp so I can't seek an alternative without traveling over 100 miles.

     

    When I moved here we had two independent hospitals in this small town, at the time. Soon as they consolidated, prices sky-rocketed.

     

    HardToLove
    15 Mar 2013, 05:18 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    yep, thats how it works.

     

    here we have a non-profit hospital, managed by a for-profit corp. They get to lease the building for $1.00 / year from the county.

     

    They own everything that supports the hospital, including labor, and trust me the profit side keeps the non-profit .... non-profitable.

     

    There is a second hospital ran by HCA, but they are no competition. Dont offer a full range of service either. They do a lot, don't get me wrong but are mainly a feeder to Nashville.
    15 Mar 2013, 07:58 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    (NVAX) Stanley Erck, Prez and CEO, bought 100K shares of NVAX yesterday @ $2.03. Holds 300K shares now.

     

    HardToLove
    13 Mar 2013, 05:47 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Dead Pigs in Shanghai: Failing Food Safety Regulations

     

    Municipal authorities... admit that the dead pigs have tested positive for the PCV virus (Porcine circovirus) as well as other pathogens, including foot and mouth disease (FMD), swine fever, hog cholera, and blue-ear pig disease. Initial investigations have also identified Jiaxing, a city in the neighboring Zhejiang province, as the origin of the dead pigs. http://tinyurl.com/bvs...

     

    In the following link which is in Chinese, the following is reported: "... in the Jiaxing area there are rumors of large-scale "swine fever" occurring in January resulting in more than 10,000 pigs died..." http://tinyurl.com/cbm...
    ---
    I used Google translate to read the page.

     

    I noticed in that first article that the Ministry of Public Security recently started a nationwide campaign cracking down on the marketing of sick pigs, and during the celebration of the Chinese New Year in February, the police reportedly stepped up efforts to rid the market of tainted pork meat. So instead of selling meat from sick pigs, the farmers dumped the large number of unmarketable dead pigs in the rivers.
    14 Mar 2013, 09:52 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    thats about what I expected.....if true, it's really bad
    14 Mar 2013, 10:24 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    It appears that Porcine circovirus is associated with "Postweaning multisystemic wasting syndrome,"something like piggie AIDS:

     

    "Both PMWS and porcine dermatitis and nephropathy syndrome (PDNS) are associated to PCV2.[4] Many pigs affected by the circovirus also seem to develop secondary bacterial infections, like Glässer disease (Haemophilus parasuis), pulmonary pasteurellosis, colibacilosis, salmonellosis and others.[5] Dissected morbid pigs showed lesions in multiple organs, especially in lymphoid tissues, giving rise to the term "multisystemic"."
    http://bit.ly/YsESBw

     

    It causes immune system abnormalities that lead to susceptibility to other diseases, ultimately affecting many major organ systems.

     

    "PCV-1 (first identified in 1974) readily infects, but is not known to cause disease in swine; the type 2 has caused problems in recent years with the increasing occurrence of postweaning multisystemic wasting syndrome (PMWS), which over time results in significant depletion of lymphocytes; postmortem examination of diseased animals reveals enlarged lymph nodes and abnormal lung tissue.
    It is still unclear whether PCV-2 (first isolated in 1997) actually causes PMWS, as infection with the virus alone causes no clinical signs; it appears to work synergistically with parvovirus, perhaps with parvovirus activating a latent form of circovirus or weakening the immune system enough for PCV to take hold. PCV-1 and PCV-2 show a high degree of sequence identity and a similar genomic organisation; nevertheless, the basis of the distinct pathogenicity has not yet been unravelled."
    http://bit.ly/12STqzu
    14 Mar 2013, 10:34 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » From todays FierceVaccines:
    Narcolepsy linked to next-gen adjuvants
    http://tinyurl.com/cqc...

     

    Note the mention that manufacturers are now fending off questions about their adjuvants ...

     

    Here is the link to the Reuters article that discusses questions about the use of new adjuvant's and the FDA ...
    http://tinyurl.com/bqz...
    14 Mar 2013, 10:56 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    FPA: The first link takes me to earthlink web mail screen.

     

    HardToLove
    14 Mar 2013, 11:01 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Sorry HT... I did not know it would link to the message in my email folder... here is the link to the article in FierceVaccine
    http://tinyurl.com/c5y...
    14 Mar 2013, 11:04 AM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    Thanks FPA!

     

    HardToLove
    14 Mar 2013, 12:04 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    FPA: Betting this news you'll find somewhere north of intriguing, timing-wise:

     

    Sinovac Biotech (SVA) Reports Preliminary Top-Line Results from Phase III Clinical Trial for EV71 Vaccine Candidate Against Hand, Foot and Mouth Disease

     

    http://bit.ly/13VvfzT

     

    FYI: Sinovac is based in Bejing, and the stock popped from the close yesterday at $3.19, opened at $3.63, and then chased all the way up to $5.08, before settling right now to $3.89, still a pop of 21.94% from the close yesterday.
    14 Mar 2013, 02:35 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Maya....good find
    14 Mar 2013, 02:38 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    March 15 (Reuters) - Zogenix Inc :
    * Reports fourth quarter and full year 2012 financial results
    * Q4 loss per share $0.01
    * Q4 earnings per share view $-0.17 -- Thomson Reuters I/B/E/S
    * Q4 adjusted non-GAAP loss per share $0.16 including items
    * Q4 revenue $9.5 million versus I/B/E/S view $9.9 million

     

    The beat earnings by a penny...stock up on the day.
    15 Mar 2013, 09:58 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Novavax, Inc. (Nasdaq: NVAX) reported that David C. Flyer, Ph.D., Director of Preclinical Development at Novavax, presented recent preclinical findings from the company's respiratory syncytial virus (RSV) vaccine development program at the XV International Symposium on Respiratory Viral Infections in Rotterdam, the Netherlands. He reported that in preclinical studies, Novavax' RSV vaccine candidate induced anti-RSV antibodies capable of neutralizing RSV in vitro and significantly reduced infectious RSV in a cotton rat challenge model. Further, in both clinical and preclinical studies, he reported that palivizumab-competing antibodies were generated at titers significantly above that found to be protective in both humans and cottons rats.
    Dr. Flyer stated during his presentation: "Both the human and cotton rat data suggest that our RSV vaccine candidate induced robust antibody responses with activity similar to palivizumab, which is a licensed anti-RSV monoclonal antibody indicated for the prevention of RSV disease in at-risk children and infants. These data provide further scientific evidence that our vaccine candidate may have the potential to safely protect infants in the first few months of life, where morbidity and mortality from RSV is greatest, as well as other affected populations including pediatric and elderly patients."
    In October 2012, the company initiated two separate dose-ranging clinical trials, one in women of child bearing age and the other in elderly adults. The first trial is a randomized, blinded, placebo-controlled Phase II clinical trial evaluating the safety and immunogenicity of two dose levels of the RSV vaccine candidate with and without an aluminum phosphate adjuvant, with 330 women of childbearing age enrolled. Top-line data from this trial are expected to be announced in April 2013. The second trial is a randomized, blinded, placebo-controlled Phase I clinical trial evaluating the safety and immunogenicity of two doses of the RSV vaccine candidate, also with and without aluminum phosphate as an adjuvant, with 220 elderly adults enrolled. Top-line data from this trial are expected to be reported later in the second quarter of 2013.
    News Provided by Acquire Media Corporation
    18 Mar 2013, 08:15 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    This may put to rest the adjuvant problem.
    18 Mar 2013, 08:16 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Dynavax hires global operations mgr.
    http://seekingalpha.co...
    22 Mar 2013, 07:03 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    India and North Africa deaths from swine flu climbing. By Feb 27 there were already 254 deaths in India. Must be a lot higher by now.

     

    http://bit.ly/tb0kz2
    28 Mar 2013, 11:21 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » India to rule on Novartis patent for cancer drug Glivec

     

    India's Supreme Court is due to rule on a patent case involving Swiss drug company Novartis (NVS), which campaigners say could threaten access in poorer countries to cheap generic drugs.

     

    Novartis wants protection for an updated version of cancer drug Glivec. It is seeking to overturn a decision by Indian officials to refuse a patent on the grounds that the new version was only slightly different from the old. Medical charities say a Novartis win would set a "dangerous precedent" http://tinyurl.com/bqf...
    ---
    My guess is their Supreme Court will not uphold the patent, in which case the stock should drop. The stock is currently at a decade high and has been trending up since November 2012.

     

    Anyone think they will uphold the patent?
    1 Apr 2013, 12:10 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Well that was quick... I was hoping there would be time to make a play...

     

    Novartis: India rejects patent plea for cancer drug Glivec
    India's Supreme Court has rejected a plea by Novartis to patent an updated version of its cancer drug, Glivec. http://tinyurl.com/bqf...
    1 Apr 2013, 03:15 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    FAP, China just sorta steals tech and uses it. India seems to play hardball and not allow the price gouging the USA has allowed with these minor patent changes.
    Several companies are finding India very difficult to deal in.

     

    Companies & countries are doing these fast moves so the mkt. can't react or play the news....not sure what to make of that.
    1 Apr 2013, 04:42 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    NVAX & ZGNX ... NVAX has quietly moved higher to the 2.25 range, with no news I can find.

     

    ZGNX, should be hearing soon on the FDA hearing that was delayed.

     

    If anyone finds news, please post. I still hold a tiny position in both from the trade last year.
    1 Apr 2013, 04:46 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    April 1 (Reuters) - BioCryst Pharmaceuticals Inc :
    * Provides update regarding peramivir
    * Says received a preliminary comment letter from the U.S. food & drug
    administration
    * FDA suggested company request a pre-NDA meeting to reach agreement on a
    complete NDA submission
    * Letter outlines pathway by which co could file nda for regulatory nod of
    intravenous peramivir
    * Got notification from department of health and human services for a stop-work
    order directing co to cease work on peramivir
    * Notification confirmed that biomedical advanced research and development
    authority will support and fund certain activities
    * Source text for Eikon
    * Further company coverage ((Bangalore Newsroom; +1 646 223 8780))
    For Reuters Top News page click the following link:
    1 Apr 2013, 06:58 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I was surprised when they had to cease work on Peramivir, it was being used where Tamiflu didn't work.

     

    BCRX may be worth watching now.
    1 Apr 2013, 06:59 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    8:29 AM BioCryst Pharmaceuticals (BCRX) receives letter from FDA which it says "outlines a pathway by which a NDA [could be filed] seeking regulatory approval of intravenous permavir." Last November, shares were nearly cut in half after permavir disappointed in clinical trials. Shares +15% premarket. Comment! [Healthcare]
    1 Apr 2013, 08:31 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    New Swine / Avian Flu claims two lives in China, another article on Bloomberg.com asks if it's the "floating pigs" that caused it.

     

    This could be one reason the feds are relooking at BCRX peramavir drug....just a guess tho.
    http://bloom.bg/XUCfWQ
    2 Apr 2013, 04:34 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Hi LT - Thanks for posting that. Here is some more info from another source...

     

    It's H7N9 avian influenza, which has not been found in humans previously. The better known H5N1 avian flu virus has infected more than 600 people since 2003, of which 371 have died.

     

    Since the transmission of the H7N9 virus from animals to humans is "extremely inefficient," there are often tens of thousands of infected birds for every human case, according to Malik Peiris, a professor at Hong Kong University's School of Public Health. As a consequence, it 's likely that there is a widespread outbreak happening" among the animals from which it came. http://tinyurl.com/cv5...
    ---

     

    Lots of sick pigs and sick birds sounds like an environment for the development of mutations. This brings up the "mixing vessel" theory. Because swine are susceptible to infection with both avian and human influenza viruses, novel reassortant influenza viruses can be generated in this mammalian species by reassortment of influenza viral segments leading to the “mixing vessel” theory.

     

    The mortality rate of H5N1 avian influenza in humans is high; WHO indicate 60% of cases classified as H5N1 resulted in death. We have limited stockpiles of H5N1 vaccine, but I don't know if that would work against something like H7N9 or some other variant.

     

    Issues Associated With Rapid Vaccine Production:
    This highlights the importance of the rapid production of vaccines in conjunction with the development of quick testing protocols. Stockpiles for known viral threats are important, but if a new threat emerges and stockpiled vaccines are not effective, there is not going to be time to conduct the usual multi-stage clinical trials.
    2 Apr 2013, 07:15 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    There are 2-3 stories in this post....first, I have posted before that Tamiflu effectiveness at all is questionable. IMO, it may have been effective on older weaker strains of flu. We gave lot's of it at the hospital well outside the window of the time it had to be started to be effective....but there was nothing else so it kept us out of a lawsuit based on doing nothing. Roche is/was to big to beat on the trials in new strains of flu.

     

    BCRX Peramivir development was funded by the gov't and the CDC stockpiled it. We gave it in some hard to treat flu cases and it seemed to work. So I was surprised when they pulled the trials saying it had "zero" effect. IMO, it's probably similiar to Tamiflu, in that it does work on some strains but not all. On a very micro level there are different variants and maybe even variants within variants. So it could very well work on some that Tamiflu doesn't but with mutations and more variants it is not 100% but still works.

     

    So, just taking a wild guess....Someone in the CDC could have shared some research info with the FDA telling them the areas that Peramavir did work in trials. Leading the FDA to send the letter to BCRX telling them how to set up a new trail that will lead to a limited label and approval

     

    I find it too coincidental that after the China outbreak all the above took place. I would say they have nothing to fight it with and are pulling all stops to at least have a chance or some hope. Peramivir is all we have until NVAX & a couple of others get their vaccines to cover more strains.

     

    It pays to watch, the last time a big scare came, BCRX went to >$15/shr. Not saying it will this time, but $3 is easily reachable. I have traded BCRX for years. It is a company with more than 9 lives. I did not buy this time on the crash, because they lost like 4 out of 6 new trial drugs...I thought this might do them in for years. This could be the turning point for them if true .
    2 Apr 2013, 07:50 AM Reply Like
  • Mercy Jimenez
    , contributor
    Comments (2021) | Send Message
     
    Thought some of you small biotech junkies might enjoy a 5 star analysis by Joe Springer of MNKD. It is a Pro article so it will not be up forever -- but it is probably the most in-depth analysis of any stock I have seen on SA. Very much worth a read: http://seekingalpha.co...
    2 Apr 2013, 02:13 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    It does look like a very detailed article. Too long to read at the moment, but I clipped it to Evernote to read in the evening.

     

    I already know the MNKD story and have been long since last July. It will be a game changer in DM management and should get approved in the third go round with FDA.

     

    Thanks, Mercy
    2 Apr 2013, 02:49 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » And more on H7N9
    China reported on Tuesday that four more people in one province were seriously sickened by a bird flu virus new to humans. China reports that the four latest cases follow three earlier ones reported on Sunday, including two men who died in Shanghai, resulting in the city activating an emergency plan that calls for heightened monitoring of suspicious flu cases.

     

    Cases of severe pneumonia with unclear causes are to be reported daily by hospitals to health bureaus, up from the weekly norm. The plan also called for stronger monitoring of people who work at poultry farms or are exposed to birds. The H7N9 strain has previously been considered not easily transmitted to humans, unlike the more virulent H5N1 strain, that has since killed 360 people worldwide. http://tinyurl.com/bt8...
    2 Apr 2013, 02:37 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Excellent NVAX announcement an hour ago:
    http://bit.ly/12dEXKg
    2 Apr 2013, 05:36 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    O.G.: And further confirmation of alum as the adjuvant should help too. Cheap and no risks.

     

    Now the question is do they need to raise funds to continue the study or will PATH or similar provide the funding. Will the recent buyers of the issuance use this to unload and take their profits, or are they long-term oriented?

     

    Questions, questions.

     

    MHO,
    HardToLove
    2 Apr 2013, 05:41 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    NVAX: Up 6% after hours.
    2 Apr 2013, 05:42 PM Reply Like
  • Mayascribe
    , contributor
    Comments (9806) | Send Message
     
    NVAX's BOD James F. Young's 100K purchase on March 10, is telling (for $2.03/share).
    2 Apr 2013, 05:46 PM Reply Like
  • H. T. Love
    , contributor
    Comments (17749) | Send Message
     
    O.G.: For some reason that link doesn't work now.

     

    Here's a fresh one if it still doesn't work later.

     

    http://bit.ly/Z6WL5Z

     

    "Novavax Reports Positive Top-Line Results From Phase II Clinical Trial of RSV Vaccine Candidate in Women of Childbearing Age"

     

    Conference call & webcast 4/3 at 10:00

     

    HardToLove
    2 Apr 2013, 06:01 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    They are starting Phase 3. Yippee!
    3 Apr 2013, 08:43 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    big quarter coming up for biotech's
    http://bit.ly/10piTfo
    3 Apr 2013, 05:05 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Bloomberg short write on :
    I believe this threat is real....watch closely.
    China preparing for Avian Flu:
    http://buswk.co/107dQ3k
    3 Apr 2013, 05:37 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    NVAX .. long/short case...pretty good read
    http://seekingalpha.co...
    3 Apr 2013, 08:41 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Started a position in CYTK today. Very promising pipeline and potential partnerships. Good catalysts in the next couple of years.

     

    http://seekingalpha.co...

     

    http://seekingalpha.co...
    3 Apr 2013, 11:00 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Tirasemtiv is in the medical news today.

     

    http://bit.ly/XdS79y

     

    The actual poster for this study is at http://bit.ly/17byH9s

     

    I have a family member with myathenia gravis, so I have been watching this for several months. I am hoping he can get into the phase III study with Dr. Sanders at Duke.
    3 Apr 2013, 01:20 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    OG ... didnt u mention this awhile ago?

     

    11:05 AM Australia-based biotech Novogen (NVGN +36.7%) soars after the company reports positive data from a study of its CS-6 drug for ovarian cancer. The company claims CS-6 proved "highly cytotoxic against all cancer stem cell lines tested with the cytotoxicity evident as early as 4 hours." Comment! [Healthcare, On the Move]
    3 Apr 2013, 11:13 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    Nope that one isn't mine. The one I am following --*no position--is Aussie also- it's
    starpharma. They had a good announcement:
    http://bit.ly/XOcsUK
    3 Apr 2013, 04:14 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    I remember discussing NVGN and this drug way back last year. If this works, it is a block buster, watch for new developments and it's a buyout candidate for sure.

     

    If I remember correctly this is tx. for the cancer related to genital warts caused by HPV and something like 40% of the population is afffected by this.
    3 Apr 2013, 06:29 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Is new bird outbreak linked to 20,000 dead pigs? Three die in China as scientists isolate new strain of killer virus

     

    http://bit.ly/10wAJvZ

     

    <<In an intriguing piece, Pulitzer Prize-winning science writer Laurie Garrett has now suggested that the virus that killed the pigs could be linked to the new strain of bird flu.

     

    Writing for the highly respected foreignpolicy.com website, she said: 'One very plausible explanation for this chain of Chinese events is that the H7N9 virus has undergone a mutation -- perhaps among spring migrating birds around Lake Qinghai.

     

    'The mutation rendered the virus lethal for domestic ducks and swans.

     

    'Because many Chinese farmers raise both pigs and ducks, the animals can share water supplies and be in fighting proximity over food -- the spread of flu from ducks to pigs, transforming avian flu into swine flu, has occurred many times.

     

    'Once influenza adapts to pig cells, it is often possible for the virus to take human-transmissible form.

     

    'That's precisely what happened in 2009 with the H1N1 swine flu, which spread around the world in a massive, but thankfully not terribly virulent, pandemic.'

     

    Today Chinese authorities dismissed such speculation and insisted that the H7N9 outbreak was not linked to the animal deaths.>>
    3 Apr 2013, 05:04 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Today Chinese authorities dismissed such speculation and insisted that the H7N9 outbreak was not linked to the animal deaths.

     

    So they attempt to remove this option from the table before they even have an answer which will leave them with only the wrong answers left on the table to search through. Seems govts from all over the world are using the same play book for all problems be they financial,tax, or medical. No wonder we are getting nowhere....but we are getting there quickly it seems.
    4 Apr 2013, 04:44 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    Very good article on ZGNX, it could be well worth your time to read:
    http://seekingalpha.co...
    4 Apr 2013, 02:22 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » (Reuters) China culls birds as bird flu deaths mount
    Chinese authorities slaughtered over 20,000 birds on Friday at a poultry market in the financial hub Shanghai as the death toll from a new strain of bird flu mounted to six, spreading concern overseas and sparking a sell-off on Hong Kong's share market. http://tinyurl.com/cmh...

     

    Link to a CNN article:
    Shanghai closing all live poultry markets as China avian flu toll rises to 6 http://tinyurl.com/cb5...
    5 Apr 2013, 06:02 AM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    H7N9 worries affecting air travel and tourism:

     

    http://bit.ly/XhCsq3
    5 Apr 2013, 09:00 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    If you notice, NVAX dropped into the high $2.20's yesterday, back to $2.40 today PM after that article. BCRX up slightly too. IMO, it's all related.
    5 Apr 2013, 10:03 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    11:09 AM BioCryst Pharmaceuticals (BCRX +17.4%) pops on news that six deaths in China have been linked to a new strain of avian flu. BCRX is developing peramivir, which has been shown in preclinical studies to help treat highly virulent strains of influenza - including the bird flu strain known as the H5N1 virus. Other drug stocks moving higher on the news: Pure Bioscience (PURE +15.6%), Hemispherx BioPharma (HEB +13.3%), Sinovac Biotech (SVA +7.8%), and Novavax (NVAX +1.1%). Comment! [Healthcare, On the Move]
    5 Apr 2013, 11:17 AM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    http://seekingalpha.co...

     

    NVAX, BCRX, and two other bio's that have possibilities and their targets by analysts.
    8 Apr 2013, 05:00 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    New swine flu may stem from multiple sources making it real bad for humans.

     

    http://bloom.bg/Ybu3l6
    9 Apr 2013, 06:49 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    10:37 AM China reports five new cases of the H7N9 avian flu including a death in Shanghai. What to watch: Keep an eye on Yum Brands (YUM +0.5%). Though the restaurant operator has already reported on the negative impact of the bird flu on March sales, many of the most alarming headlines have been April events. In addition, the buzz from Weibo is that some Chinese consumers are debating giving up chicken on safety concerns. Comment! [Consumer, On the Move, Global & FX]
    11 Apr 2013, 10:47 AM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    A look at the outbreaks on the global incident map is quite interesting.

     

    http://bit.ly/tb0kz2
    11 Apr 2013, 05:56 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Note the stuff in east Australia too.
    11 Apr 2013, 05:58 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Guns, it turns out that action you noted in east Australia is related to a Tamiflu resistant swine flu ... Here is an article on BBC that describes the situation..

     

    Drug-resistant pandemic swine flu 'community risk'

     

    Australian experts are concerned about the threat of a new type of drug-resistant seasonal variant of the pandemic flu that is circulating in the population at large. One seasonal variant of the swine flu strain has learned how to dodge the antiviral Tamiflu and, though rare, is emerging outside of hospitals. The team who have studied it say the virus is "fitter" than other drug-resistant strains and the world should be on alert for outbreaks.

     

    Apparently, Tamiflu is powerless against this new seasonal strain that has been found in people in the community rather than sick patients with serious underlying conditions and weak immune systems.

     

    The new strain that they have been examining is emerging among people who have never been treated with Tamiflu, suggesting it is very good at spreading from person to person. [I am not sure of the meaning of this... perhaps our good doc SMaturin could comment on the implications of this?]

     

    Although the Tamiflu-resistant strain is still relatively rare, affecting about 2% of people with swine flu in the Australian population, health authorities are concerned that it has the potential to turn global. http://tinyurl.com/d3c...
    ---
    11 Apr 2013, 07:14 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    The whole southeast asia area is in biological chaos.
    11 Apr 2013, 07:26 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    FPA,

     

    The issue with Tamiflu resistance is that influenza viruses have mutated to develop a neuraminidase protein that is not inhibited by oseltamivir (Tamiflu). Explained elegantly here in the section on neuraminidase inhibition resistance: http://bit.ly/16XMsFQ

     

    Recall that influenza strains are classified by their hemagglutinin and neuraminidase surface proteins, e.g H1N1, H7N9, etc. Both proteins are involved in the infective replication cycle of influenza viruses, and both are "antigenic", meaning our immune system recognizes them and forms antibodies against them to overcome infection, and to provide future immunity to prevent infection. Vaccines contain purified versions of these proteins (or killed deactivated virus particles containing the proteins), which stimulate our immune system to produce the antibodies (which attach to these surface proteins and prevent them from functioning, which is the same thing Tamiflu does to the neuraminidase protein) BEFORE we encounter the live virus, thus giving protection against infection.

     

    However, in the wild, the viruses undergo spontaneous mutations frequently, so that the surface proteins change sufficiently that our immune system can no longer recognize them, or the antibodies do not attach to them and deactivate them. The H1 protein mutates to an H5 or H7 or H-whatever, to which we do not have an imune response. This process is referred to as "antigenic drift" and is the reason a new vaccine with the latest round of H and N proteins detected in the wild needs to be developed every year.
    11 Apr 2013, 11:21 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Ahhh Thanks Doc!!!
    11 Apr 2013, 11:51 PM Reply Like
  • SMaturin
    , contributor
    Comments (2275) | Send Message
     
    Another issue regarding Tamiflu: it only works while you are taking it and serum levels are high enough to have an inhibitory effect on virus replication. The first anti-influenza medication was amantidine, developed back in the 80's, which only worked on Influenza A strains. All of the anti-influenza drugs work in a similar fashion, by binding to and inhibiting viral surface proteins that play a role in the virus replication cycle. Viruses need to bind to a host cell, inject their genome into the host cell, take over the host-cell's DNA production machinery to produce viral genes, and then send the packages of viral genes back to the host cell surface to be release as a new viral packet. Proteins involved in accomplishing all of these steps are the targets of antiviral drugs.

     

    Whereas vaccines create a more lasting immunity, because they trigger an immune response to produce antibodies against one or more of the surface proteins. The antibodies then remain in our circulation indefinitely to provide the first defense against further infections.

     

    You noted above: "The new strain that they have been examining is emerging among people who have never been treated with Tamiflu, suggesting it is very good at spreading from person to person."

     

    These two statements do not really fit together. The first half has to do with viral susceptibility to the drug, while the second half of the sentence has to due with viral virulence and transmissibility, or host susceptibility to infection. The girl in whom Tamiflu resistance was first noted, according to the Wikipedia article I referenced, was taking Tamiflu and got sick anyway. This is what led researchers to conclude that the virus had developed resistance to Tamiflu. It does not matter whether an individual has any previous exposure to Tamiflu, only whether they are currently taking it when exposed to the Tamiflu-susceptible virus. Resistant strains emerge in populations where antiviral drug use is common, so the virus has increased chance of mutating to form a resistant strain due to natural selection effects. .

     

    Whereas, the ease with which a virus is transmitted from one human to another to cause infection, or from animals to humans (zoonotic transmission), is determined by other factors having to do with the viral surface antigens evolving to be more effective at invading host cells and evading the immune response of the host. It is a constant battle in the wild. Previous Tamiflu exposure in the host has no effect on the evolved transmissibility of the virus.

     

    Antibiotic or antiviral resistance occurs when the drug is being used widespread enough that somewhere a virus (or bacterium) mutates to develop proteins that are resistant to the drug, so that new strain of bug can thrive and spread in the presence of the drug in the host population. It has little to do with previous host exposure to drug, but much to do with cumulative population use of the drug, which increases the chances for a successful random mutation to occur in a bug which confers drug-resistance, and then for that mutation to be selected for in the population where drug use is widespread.

     

    Bacteria and viruses can undergo recombination processes, where they share genes with each other if they are both present within a host, and thus the mutation conferring resistance can spread to other types of infections agents. This process is referred to in viruses as "antigenic shift." http://bit.ly/YuzaBF
    12 Apr 2013, 09:22 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » I see a lot of Dengue Fever too... there was a recent estimate that Dengue Fever was being unreported by a factor of 4, and it was already big time when it was under reported. I had a news concentrator on Dengue at one time... I suppose I should resurrect it one of these days and see how the Dengue vaccine development is proceeding...
    11 Apr 2013, 06:15 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    I remember that insta on dengue was when we were planning the trip to honduras. It was very appropriate info then and obviously now too!!

     

    Look at the bird flu deaths from Viet Nam to India, its getting ugly. Swine flu too!!.
    11 Apr 2013, 06:18 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    ok, so how do we play this ?
    11 Apr 2013, 07:08 PM Reply Like
  • doubleguns
    , contributor
    Comments (8163) | Send Message
     
    Step one, stay alive
    Step two, pay attention to where the problems are.
    Step three, stay away from the problems.
    Next return to step one.
    After this your on your own. NVAX and a host of others are working the issue. I have no idea yet who is gonna win. You've had some good choices LT keep working them.
    11 Apr 2013, 07:13 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    If you go back to the way beginnings of this blog, you will see diff ways to play a possible epidemic. We started (before the swine flu scare) looking at the companies that sell masks, needles, hand sanitizer, over the counter drugs, you name it.
    12 Apr 2013, 02:18 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » Up in the header of the concentrator there is a list of potential plays called: Brief Overview of Categories of H1N1/ Vaccine Investment Plays

     

    The list shows several different categories and stock plays...
    12 Apr 2013, 09:57 AM Reply Like
  • Mercy Jimenez
    , contributor
    Comments (2021) | Send Message
     
    FPA,

     

    You may want to consider adding CSL headquartered in Australia to your stock play list above. They have been a great play for me and are up 68% over the last 12 months. I have always liked their unique geographic proximity to the Asian markets.

     

    "“Diversification does give them [CSL] some alternative income streams,” Goodsall said, adding CSL’s vaccine against pandemic swine flu made a “materially high contribution to profit” in the year ended June 2010. " http://bloom.bg/XHxG7t
    mj
    12 Apr 2013, 12:15 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (5953) | Send Message
     
    Author’s reply » CSL added. Thanks Mercy.
    12 Apr 2013, 01:07 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    * Faster DNA method shaved 2 weeks off vaccine process
    * Chinese researchers say counter measures 'urgently needed'
    By Julie Steenhuysen
    CHICAGO, April 11 (Reuters) - Even as U.S. officials this week awaited the arrival of a sample of the new bird flu virus from China - typically the first step in making a flu vaccine - government-backed researchers had already begun testing a "seed" strain of the virus made from the genetic code posted on the Internet.
    This new, faster approach is the result of a collaboration among the U.S. government, vaccine maker Novartis and a unit of the J. Craig Venter Institute, which is using synthetic biology - in which scientists take the genetic code of the virus and use it as a recipe to build the virus from scratch.
    It was an idea born in the aftermath of the 2009 H1N1 pandemic, in which production delays and poor-quality seed strain slowed delivery of the vaccine until October, late enough that people were already sick with swine flu.
    The new method has shaved two weeks off the vaccine-making process. It will take five to six months to ramp up production, but even weeks could make a difference in the case of a potentially deadly flu pandemic, said Robin Robinson, director of the Biomedical Advanced Research and Development Authority or BARDA.
    "We'll take it," said Robinson, whose agency handles pandemic preparedness as part of the U.S. Department of Health and Human Services. "If the virus turns out to be a tough one, that could be very important."
    At least 33 people have been infected and 10 have died from the strain of bird flu known as avian influenza A (H7N9) first found in humans last month. So far, the strain does not appear capable of being passed from person to person.
    But Chinese researchers, in a report published online on Thursday in the New England Journal of Medicine, warned that the sudden emergence of this strain of flu "may pose a serious human health risk" and said "appropriate counter measures were urgently required."
    SOUL SEARCHING
    An especially deadly strain of bird flu in 2003 known as H5N1 had already raised the threat of a global pandemic, spurring more than $2 billion in government contracts to shore up U.S. flu vaccine manufacturing capabilities.
    After the 2009 H1N1 pandemic, U.S. health agencies gathered to do some soul searching. Representatives from BARDA, the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health looked for ways to expedite the process of making flu vaccines, Robinson said.
    These advances would need to apply to all vaccine makers, whether they used the traditional method of growing the virus in live chicken eggs, or the newer methods of growing it in cells or vaccines made from genetically engineered proteins.
    Robinson, who formerly headed the vaccines division at Novavax Inc , had seen firsthand the speed at which a vaccine could be made using synthetic biology during the 2003 outbreak of Severe Acute Respiratory Syndrome or SARS, when companies and governments rushed to make a vaccine.
    So, in 2010, BARDA tapped Novartis, one of its vaccine partners, along with a company owned by Dr. J. Craig Venter, the flamboyant scientist who took part in the race to map the human genome and caused a stir in 2010 when he used synthetic genes to create a custom microbe and bring it life.
    TEST DRIVE
    As a test drive for the new flu technology, in 2011 the government gave its partners the genetic sequence for a North American strain of H7N9, a similar virus to the one making people sick in China. "It was just a coincidence," Robinson recalls.
    In less than two weeks, Novartis and Venter's group were ready to make virus seed. The next year, they sequenced an H5N1 virus and produced a synthetic virus in six days.
    Then came a live test. The United States asked its partners to make a real vaccine for a variant of swine flu known as H3N2 that had been infecting children in the U.S. Midwest last year.
    Once again, they produced virus seed in less than a week.
    So, when Chinese health authorities released the genetic sequence for the H7N9 bird flu on March 30, U.S. health officials decided to try the new technique.
    Novartis and Venter's company, Synthetic Genomics Vaccines Inc, went to work and by April 4, they had synthetic DNA ready and had started to grow the virus in cells, long before samples of the actual virus arrived from China on April 11.
    Normally, getting a sample would be the starting point for making a seed virus, which would then be grown and tested to ensure it would grow well in chicken eggs or cells.
    That involves a certain amount of guesswork, however. The new process of building the virus based on its genetic code allows "almost guaranteed success," said Mike Shaw, director of the U.S. Centers for Disease Control and Prevention.
    "That is because you're creating a virus that is almost tailor-made," he said.
    Shaw said the CDC plans to take a vaccine candidate at least to the stage of human safety trials, a process that will take several months.
    (Reporting by Julie Steenhuysen; Editing by Douglas Royalty and Lisa Shumaker)
    ((julie.steenhuysen@th... Messaging: Julie.steenhuysen.reut...
    Keywords: USA BIRDFLU/VACCINE
    For Reuters Top News page click the following link:
    http://bit.ly/xSc0H9
    Copyright (C) Reuters 2013. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without t e prior written consent of Reuters.
    12 Apr 2013, 08:30 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5060) | Send Message
     
    It's up to 38 cases in China (and all had direct contact with chickens). While it can mutate, the authorities do not expect it to turn into a pandemic.Right now it isn't passed between people.
    The report I read from the New York Times said the Chinese have been sitting on the information since February and didn't report it until the end of March.
    The dead suffered severe pneumonia, septic shock and other complications that damage the brain, kidney and other organs.
    12 Apr 2013, 03:14 PM Reply Like
  • LT
    , contributor
    Comments (4869) | Send Message
     
    OG, add to that list of symptoms lung collapse, and even people on a ventila