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  • Swine Flu AND Medical News Concentrator October 13, 2012 To December 31, 2012 77 comments
    Dec 3, 2012 7:35 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 News Concentrator June 13, 2012 to October 13, 2012

    tinyurl.com/9l3u3d6

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

    Swine Flu News Concentrator May 12, 2011 to July 29, 2011 tinyurl.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)
    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) (NASDAQ: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 (77)
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  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    (NVAX): "Novavax Initiates Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly Adults"

     

    "We expect to report top-line results from this study in the second quarter of 2013."

     

    http://bit.ly/QOw1oU

     

    HardToLove
    16 Oct 2012, 09:12 AM Reply Like
  • doubleguns
    , contributor
    Comments (9600) | Send Message
     
    Elderly Adults!!!

     

    Any of y'all get a call on that. I didn't!!!
    16 Oct 2012, 06:22 PM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    DG: Maight have. I might not have been able to hear the phone ring! ;-))

     

    Or get out of my recliner fast enough to answer, or ...

     

    HardToLove
    17 Oct 2012, 08:23 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    NVAX passes phase 1 trials on flu vaccine....looks to be up big today.....Question:

     

    Does anyone see a capital raise coming on this strength?
    18 Oct 2012, 06:51 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    nvax
    http://seekingalpha.co...
    18 Oct 2012, 08:08 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    This could be the Holy Grail of Cancer treatments, China "thunder-god-vine" cures pancreatic cancer in 40 days in mice & to start human trial soon:

     

    http://bloom.bg/R1oy5R

     

    this is way way early, but got to be watched. HTL help me set up alerts on this.
    18 Oct 2012, 07:00 AM Reply Like
  • doubleguns
    , contributor
    Comments (9600) | Send Message
     
    This herb is good for arthritis too. Thanks for the info. Ordered some from china already. Ebay has it at $2.00 per 100 grams.
    18 Oct 2012, 03:03 PM Reply Like
  • Mayascribe
    , contributor
    Comments (11197) | Send Message
     
    Guns: When you visit Copan, I'm hoping friend David Sedat takes us up to his award winning "Useable Forest" that he created only about 15 years ago. The most profitable and intriguing product grown up there on top of what once was a scalped mountain top, is the noni plant, of which aside from being a possible cure to cancer, can potentially also fight a wide array of maladies. The following link takes you to cancer.org, where the noni plant is discussed in greater detail...it's one amazing plant!

     

    http://bit.ly/TD3emJ
    19 Oct 2012, 05:00 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    We need to find out from a Chinese what the dose regimen is. This could be useful info.
    19 Oct 2012, 05:30 PM Reply Like
  • doubleguns
    , contributor
    Comments (9600) | Send Message
     
    Page 3 has doses.

     

    http://bit.ly/Vwp56i

     

    According to this info you should not go any where near this stuff.

     

    http://bit.ly/RQFXhv
    22 Oct 2012, 05:47 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    thanks DG.
    22 Oct 2012, 06:52 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    BCRX halted on news pending .... this mornings news is in full swing.
    18 Oct 2012, 07:03 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    This deal to also hinge on $60 million capital raise.

     

    New company to focus on oral drugs for hepatitis C and hereditary angioedema
    Combined HCV portfolio includes three complementary viral targeting mechanisms
    RESEARCH TRIANGLE PARK, N.C. & SAN FRANCISCO--(BUSINESS WIRE)-- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) and privately held Presidio Pharmaceuticals, Inc. today announced that the companies have signed a definitive merger agreement for Presidio to be acquired by BioCryst in an all-stock transaction. The transaction has been approved by the Boards of both companies. The transaction values Presidio at approximately $101 million, based on yesterday's closing BioCryst share price of $4.11 per share. The transaction is expected to close in the first quarter of 2013, and is subject to customary conditions, including approval by BioCryst shareholders.
    18 Oct 2012, 07:34 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    GERON...(GERN) can some one go read the news on GERN & give feedback?

     

    Someone is forming a new company to take on the "stem cell" part of GERN that is now lying dormant at GERN and offering to give GERN shareholders a 45% stake in the new company.
    18 Oct 2012, 09:09 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    (NVAX): "Novavax Reports Positive Top-Line Results From Two Phase 1 Trials of Pandemic Influenza Vaccine"

     

    - Vaccine candidates met safety and immunogenicity endpoints in both trials
    - Trials' results support further development of vaccine in larger trials
    - Adjuvanted candidates, at all doses of antigen tested including 3.75 µg dose, achieved dose-sparing goals with seroconversion and seroprotection rates from 86% to 100%
    - Unadjuvanted vaccine candidate, at 45 µg dose, achieved >82% seroconversion and seroprotection in both trials
    - Phase 1 results fulfill FDA criteria for accelerated approval; future confirmatory trials planned
    - Cross-reactive antibody responses observed for a second strain of A/H5N1

     

    http://bit.ly/REnuVa

     

    HardToLove
    18 Oct 2012, 10:55 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » From the FluView Newsletter - by Centers for Disease Control and Prevention

     

    Synopsis:
    Week 41 (October 7-13, 2012), influenza activity remained low in the United States.

     

    http://tinyurl.com/bfptu
    19 Oct 2012, 07:07 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Zogenix, Inc. (Nasdaq: ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today that John Turanin, vice president and general manager, Zogenix technologies, is scheduled to make a presentation that highlights successful repositioning of injectable sumatriptan for migraine with a novel needle-free delivery technology at the 2nd Annual Drug Repositioning & Indications Discovery Conference, which is being held on October 23-24, 2012 in San Francisco, Calif. The case study demonstrates increased physician and patient adoption of a standard therapy when enhanced with the DosePro Needle-free Delivery System.
    Mr. Turanin's presentation, which will take place at 9:30 am PT on October 23, is a case study on Zogenix's first commercialized product utilizing DosePro technology, SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, for the acute treatment of migraine and cluster headache. Mr. Turanin will examine the introduction of SUMAVEL DosePro to the U.S. market, including an analysis of the factors affecting the adoption of injectable products. For SUMAVEL DosePro, this included patient acceptance of a needle-free subcutaneous self-injection product despite the availability of oral or nasal alternatives.
    News Provided by Acquire Media Corporation
    23 Oct 2012, 04:59 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Novavax, Inc. (NASDAQ: NVAX) has raised a total of $27 million through the sale of 12,285,321 shares of its common stock to RA Capital Management, Camber Capital Management and Ayer Capital Management at a price of $2.18 per share. The shares were offered under an effective shelf registration statement previously filed with the Securities and Exchange Commission.
    Novavax received proceeds, after deducting offering expenses, of approximately $26.9 million. The net proceeds of the financing will be used for general corporate purposes, including working capital, product development and capital expenditures.
    News Provided by Acquire Media Corporation
    23 Oct 2012, 05:06 PM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    LT: About 10% of float, 9% of outstanding.

     

    Let's see if pps reacts today.

     

    Should make it more likely to improve on the analysts' expected loss/share. With misses the last two quarters and current and next ($0.04) per share expected, maybe they'll "beat" next time - I guess it's too late for this time, 10/29. They should've done it in September.

     

    HardToLove
    24 Oct 2012, 07:21 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » I think that offering price was quite good. To me it signals that the value of the shares was accepted by a money lender as being very close to the current sp.
    24 Oct 2012, 11:02 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    FPA: That was my thought as well. I was wondering if the dilutive effects would cause the frenetic crowd to start unloading though.

     

    HardToLove
    24 Oct 2012, 11:17 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    There is almost zero volume in any bio-tech today. Makes me wonder if this is the calm before the storm, or if a pause before a big drop after the financings mentioned above ?
    24 Oct 2012, 10:51 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Needed to add that I agree with FAP on the pricing.... I am impressed that no further sell off happened in all of them. NOK too for that matter on an off topic bond sale.

     

    I am mainly interested in Zogenix, NVAX & GERN.

     

    ZGNX is presenting info today and I think just raised capital. I do not own it yet but will soon. I think it's a winner or buy out candidate with the new pain drug.

     

    Italy has Novartis flu drug on hold until after further tests...NVAX too has a winner if it can speed up the trials.

     

    GERN, no one posted on the shell company trying to get it's stem cell business.
    24 Oct 2012, 11:33 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    ZGNX filled the gap at $2.40+ today. Think I should call it a buy here now at $2.50?
    24 Oct 2012, 11:51 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5180) | Send Message
     
    Italy just canned Novartis flu vaccines pending testing to determine safety.
    24 Oct 2012, 12:48 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Oct 30 (Reuters) - Geron Corp :
    * Geron Corporation reports 2012 third quarter financial results and events
    * Q3 loss per share $0.13
    * Q3 revenue $636,000 versus $220,000
    * Q3 earnings per share view $-0.14, revenue view $0.4 million -- Thomson
    30 Oct 2012, 04:33 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    6:38 PM BioCryst (BCRX) is withdrawing its Investigational New Drug application for the antiviral nucleoside, BCX5191, following discussions with the FDA. The agency indicated patient safety concerns over the preclinical toxicity profile of the drug at exposure levels which they believe are likely to be necessary to reduce the viral load in patients infected with the hepatitis C virus. [Healthcare] Comment!
    31 Oct 2012, 05:50 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    (NVAX): "Novavax Reports Third-Quarter 2012 Financial Results"

     

    Per estimates, hits EPS, (-$0.05), misses on revenues, $5.8MM vs. expected $7.59MM regardless of 16% YoY increase.

     

    "Novavax' management will host its quarterly conference call today at 10:00 a.m. Eastern time today. The live conference call will be accessible on Novavax' website at http://www.novavax.com under "Investor Info/Events" or by telephone at 1 (877) 212-6076 (domestic) or 1 (707) 287-9331 (international)..."

     

    http://bit.ly/TyGAQj

     

    HardToLove
    2 Nov 2012, 08:13 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    I hope they get hammered today, if they do...I intend to take up a trading position long. I think they have a winner in the new pain drug.
    2 Nov 2012, 08:23 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    LT: (NVAX) has no pain drug. You must be thinking of another equity.

     

    HardToLove
    2 Nov 2012, 08:32 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    sorry...the pain drug is Zogenix. NVAX is flu. I still think with Novartis problems makes NVAX a good play along with the diff flu's that are worldwide.
    2 Nov 2012, 08:35 AM Reply Like
  • doubleguns
    , contributor
    Comments (9600) | Send Message
     
    I can take the beating if it all works out good. Actually I should say I can continue to take the beating.....

     

    Rock it for me......

     

    http://bit.ly/TYb3mZ
    2 Nov 2012, 10:36 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    Big band sound. I liked that.

     

    HardToLove
    2 Nov 2012, 10:56 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » Cooking... I really liked that. Thanks.
    2 Nov 2012, 11:35 AM Reply Like
  • Mayascribe
    , contributor
    Comments (11197) | Send Message
     
    Xcellent! That was great fun. "Upbeating."
    2 Nov 2012, 02:09 PM Reply Like
  • doubleguns
    , contributor
    Comments (9600) | Send Message
     
    If you liked that here is a whole concert in Heidelberg. 1 hour 14 minutes. All good stuff. Only 150,411 views. I can't believe it.

     

    Third song Suzy at about 9 1/2 minutes with the singing duel is hilarious.

     

    http://bit.ly/PLvVTa
    2 Nov 2012, 11:47 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » Wow! I wish these guys were around when I was young. They are like an energy drink.
    2 Nov 2012, 12:37 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » OG picked up the following article http://tinyurl.com/acr... where India's government revoked the patent on Roche's (RHHBY.OB) expensive Pegasys drug for hepatitis C. She wondered about the impact on NVAX...

     

    I did some research and come up with the following article: http://tinyurl.com/aka...

     

    My take is as follows:

     

    India revoked Roche's patient citing lack of evidence that the drug was better than existing treatments available in the market.

     

    I don't think that explanation makes sense because what is patented is a specific formulation. There can be multiple formulations that work in different ways while having a similar impact. In fact, the provision of multiple mechanisms of action is important in the medical profession because some people are incompatible with some of those mechanisms. For example, cholesterol drugs like Lipitor and Zocor work differently.

     

    Drug patients are usually granted because they represent a unique and sometimes favorable mechanism of action in certain circumstances.

     

    I think the real explanation is contained in this remark....

     

    It (Roche) can opt to tie up with an Indian company and launch the drug at a much lower price or just follow a differentiated pricing policy. In other words, it could have one price for foreign markets and another for India.

     

    I think that gets at the underlying story... The Indian government is saying if you don't team up with an Indian company, and/ or offer your drug product priced relative to similar drugs in the Indian market, the government will reject your patient protection and allow Indian companies to use your drug formulation with no patient protection. Basically, Roche can fight city hall, or play ball.

     

    NVAX avoided this situation because they started out with a deal with an Indian company and played by India's rules from the beginning. Teaming up with an Indian company means profits will be constrained, but doing so pretty much guaranties unfettered access to the vast Indian market. NVAX is different from Roche because they have no drug distribution/ sales network. NVAX is basically outsourcing the marketing and selling to the Indian company.

     

    From a broader perspective, it means India is protecting it's drug market. This is a form of protectionism and it suggests that they will implement a similar strategy in other markets.

     

    Roche can either decide to play ball and offer differentiated pricing or team up with an Indian company. Alternatively, they might try to appeal the decision to the World Trade Organization which India is a member of.
    4 Nov 2012, 10:06 PM Reply Like
  • optionsgirl
    , contributor
    Comments (5180) | Send Message
     
    India has taken several protective stances in other areas as well as pharma. The notion that a patent can be revoked because the drug is expensive is terrible public policy, imo.
    There is no reason for me to believe that they wouldn't do it to their own companies as well as foreign companies. After all, this is the same government that attempted to discourage gold buying by raising import taxes to such a high level that they ultimately had to back down because of the outcry. (Poor judgement is shown repeatedly. You can't force gold bugs to buy fiat!)
    Here is an example from 2011 that happened to Tata Motors.
    Beware social engineers!
    http://bit.ly/QhgguT
    5 Nov 2012, 02:21 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5180) | Send Message
     
    p.s. From the article Ratty linked, here is why I concluded that their decision is (at least partly) due to the expense of this treatment. Perhaps I am incorrect in linking the cost to the rescission. From the article:

     

    "Treatment is very expensive. The current cost, depending on the type of hepatitis C virus, varies from Rs 3.5 lakh to Rs 6.5 lakh for a six-month to one-year treatment regimen with drugs such as Pegasys.

     

    Today, generic versions of another drug, interferon (alpha 2b), are also available in India. The cost of this treatment regimen varies from Rs 1.5 to 2.5 lakh, for the same period."
    5 Nov 2012, 02:39 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    India is following China's lead on partnering with an in-house company. I think pricing is a big issue. The world has seen the damage that health costs can do. Also read the last paragraph here on taxes.
    India & China have no plans for foreign companies to take over their economy in any area, they also are starved for advanced tech & will do whatever to get it.
    India needs infrastructure, so they need those profits to stay at home.
    I agree with you on the patent protection, it is bad policy and they will lose in the WTO court, but if so, they will just not offer is for sale in India. I view patent protection and "protectionism" as two different animals. I think in the next 10 years +/- we see protectionism implemented to some degree in the USA & globally. The main reason being corporations are paying almost zero in taxes. Look for that to change, there is an SA article showing APPLE tax rate. This won't fly much longer.
    5 Nov 2012, 04:11 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    My question on NVAX is ....

     

    Will their partnership with an Indian company hurt their buyout prospect?

     

    If NVAX can get approval and success with this flu drug, it is a winner and probably a buyout candidate IMO at a very good mark-up in pps from here. It may happen before USA approval too.
    5 Nov 2012, 04:22 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    LT: The more attractive drugs that would attract buyers is the RSV and, maybe in the future, malaria vaccines. They also have a rabies vaccine in the works which would be important in India.

     

    Adding to the attractiveness are the things mentioned above, IMO, link ups with Indian companies and working closely with the Indian equivalent of the FDA. These relationships provide ready-made access and good working relationships already in place.

     

    MHO,
    HardToLove
    5 Nov 2012, 05:10 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Bio-Cryst (BCRX) just had a disaster day.. shows the risk with bio's. I thought this drug was guaranteed. The CDC stockpiled it during the last H1N1 crisis. Thankfully I did not own it. GERN was bad enough.

     

    9:49 AM BioCryst (BCRX) -41% after ending Phase III trials of its peramivir flu drug, as "the difference between peramivir and control groups for the primary endpoint was small." BioCryst received $234.8M from the federal Biomedical Advanced Research & Development Authority to help develop peramivir . The setback follows BioCryst last week withdrawing its IND application for its BCX5191 hepatitis C compound. (PR) [Healthcare, On the Move] Comment!
    8 Nov 2012, 11:12 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    SAN DIEGO, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will review the Company's New Drug Application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules) on December 7, 2012. Zohydro ER is Zogenix's lead investigational product candidate for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Details of the meeting agenda will be available in the Federal Register.
    The Prescription Drug User Fee Act (PDUFA) date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.
    8 Nov 2012, 04:32 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    There is alot more to the ZGNX earnings release and announcements. I will be buying soon. I think the bottom or close is in today.

     

    FYI...I started buying more NVAX on this drop. Just taking 1000 share blocks on each dip.
    8 Nov 2012, 04:34 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    1000 new cases of Hepatitis outbreak in Sudan....What is Hepatitis "E" ? and what drugs work on it? Vertex?

     

    http://yhoo.it/Teq7hY
    9 Nov 2012, 06:09 AM Reply Like
  • optionsgirl
    , contributor
    Comments (5180) | Send Message
     
    Hep E is usually a short acute infection that resolves in 4-6 weeks. Usually it is passed thru contaminated water.
    Hepatits varieties:
    A, B, C, D, E ,X and G.

     

    There's a Hep E drug in development.
    Boiling drinking water helps. So does replacing electrolytes/fluids.
    9 Nov 2012, 01:44 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    6:57 PM MediciNova (MNOV) publishes positive Phase 2 results for its asthma study, MN-221, in the Journal of Asthma. MN-221 is designed to treat acute asthmatic episodes through an intravenous infusion, which bypasses constricted airways to deliver the drug directly to the lungs. The tests showed a positive lung response without an accompanying increase in heart rate - which is a major concern - when the drugs were administered. Comment! [Healthcare]
    12 Nov 2012, 07:28 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Zogenix : Here is one reason I think they are a winner. I still have no position in it yet.
    http://bit.ly/ZHUYXQ
    14 Nov 2012, 05:48 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » I have a buy in on (NVAX) at 1.51... next tranche at 1.25. These will be long term holds.
    16 Nov 2012, 11:47 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    FPA: Good plays I think. Right now I'm suspecting it may tap $1.45 or so near-term. I'm *guessing* that the combo of the share issuance and the EOY/next year tax concerns are driving selling and I'm suspicious it may continue generally down well into December.

     

    My short covered calls calls are well into the money and I'm arguing with myself about when to lock profits buy closing them out.

     

    Decisions, decisions, ...

     

    HardToLove
    16 Nov 2012, 12:23 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Here is a list of Bio-Tech's that will live or die in the first 90 days of 2013:
    http://bit.ly/TMPDZE

     

    Zogenix mentioned near the end on Mar.1
    19 Nov 2012, 02:47 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Nov 21 (Reuters) - Novavax Inc :
    * MLV cuts price target to $8.50 from $9.50; rating buy
    For a summary of rating and price target changes on U.S. companies:
    Reuters Eikon users, click on
    21 Nov 2012, 11:07 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    This is a new one for me....

     

    Flu Shots reduce heart attacks and strokes:
    http://bit.ly/UtD73P
    22 Nov 2012, 06:49 PM Reply Like
  • Mayascribe
    , contributor
    Comments (11197) | Send Message
     
    Maybe I should get one every month ;-)

     

    And schedule one annually for every Black Friday.
    22 Nov 2012, 10:10 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    11:49 AM Zogenix (ZGNX +2%) moves up after saying it's appointed R. Scott Shively as its new chief commercial officer. Mr. Shively will be responsible for all of the company's commercial strategies and operations including the marketing for ZGNX's Sumavel DosePro, as well as the anticipated launch of ZohydroTM ER, which is pending FDA approval. Comment! [Healthcare, On the Move]
    26 Nov 2012, 11:51 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    All the big boyz have new 4-flu vaccines coming for next year.
    Wonder how this hurts NVAX ?
    http://on.mktw.net/QnxAxm
    27 Nov 2012, 08:57 AM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    LT: NVAX is doing the same. Their recent trial confirmed efficacy and safety of three of the four but the fourth did not meet efficacy expectations. They are re-working that portion of it. I've no doubt it will come up to expectations.

     

    HardToLove
    27 Nov 2012, 09:06 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    BCRX...these guys can't get a break...

     

    Nov 27 (Reuters) - BioCryst Pharmaceuticals Inc :
    * The bcx4161 ind has been placed on clinical hold-SEC filing
    * Now estimates that phase 1 testing of bcx4161 will be delayed approximately
    three months
    * FDA said they were applying gmp manufacturing standards to process of
    compounding bcx4161 capsules at the clinical site
    27 Nov 2012, 09:07 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Novavax, Inc. (Nasdaq: NVAX) announced that the journal PLOS ONE published data from a preclinical study of its recombinant nanoparticle vaccine candidate against respiratory syncytial virus (RSV), demonstrating efficacy and safety in a well-established animal model. These data indicated that the use of an RSV fusion (F) protein nanoparticle vaccine that induced high levels of specific neutralizing antibodies protected animals from both RSV replication and disease.
    Severe RSV infection is the leading cause of infant hospitalization in the U.S., and globally there are 64 million cases and 160,000 deaths annually. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children are infected at least once by the time they reach their second birthday. RSV also accounts for significant morbidity and mortality among the elderly, and adults with cardio-pulmonary compromise. There is currently no approved RSV prophylactic vaccine to address this critical unmet health care need.
    News Provided by Acquire Media Corporation
    3 Dec 2012, 10:42 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » CDC says US flu season starts early, could be bad

     

    Flu season in the U.S. is off to its earliest start in nearly a decade — and it could be a bad one.

     

    Health officials on Monday said suspected flu cases have jumped in five Southern states, and the primary strain circulating tends to make people sicker than other types. It is particularly hard on the elderly.

     

    "It looks like it's shaping up to be a bad flu season, but only time will tell," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.
    3 Dec 2012, 07:34 PM Reply Like
  • Mayascribe
    , contributor
    Comments (11197) | Send Message
     
    FPA: I caught that earlier today. It's already rolled through part of my family here in PA, as well as two of my pals had the flu, all just since T-Day.

     

    Seems whatever variety they contracted that the flu lasted about 3 days.
    3 Dec 2012, 08:06 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Unless Geron has some great patents and tech, it appears to be history...sold what I had after this announcement in AH yesterday.

     

    4:15 PM Geron (GERN) says it has discontinued development of its GRN1005 brain cancer drug following disappointing Phase II trial results. The company says it will focus on the development of its imetelsat cancer drug, and will cut 43 full-time positions as part of a restructuring. Geron expects to achieve annual savings of $32M from the restructuring, and record charges of $6M. Shares are halted, and will resume trading at 4:35PM ET. [Healthcare, Breaking News] Comment!
    4 Dec 2012, 05:48 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Looks like the FDA staff is moving on schedule or ahead on the new pain drug....the warning about addiction/abuse won't hurt it. However, it will have to be labeled that way. Approval is the catalyst. Probably more later throughout the day and till Friday.

     

    Dec 5 (Reuters) - Zogenix Inc :
    * US FDA staff says if approved, Zogenix's Zohydro may be abused at a
    greater rate than current hydrocodone combo drugs
    * Further company coverage
    ((Bangalore Newsroom; +1 646 223 8780))
    For Reuters Top News page click the following link:
    5 Dec 2012, 08:56 AM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » (VICL) announced a worldwide, nonexclusive license of its patented Vaxfectin adjuvant to Cyvax, a privately held vaccine development co, for use in malaria vaccines. Financial terms of the agreement were not disclosed.
    5 Dec 2012, 10:54 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Wednesday, December 5, 12:29 PM Zogenix (ZGNX -2%) slides after the FDA raises concerns about the abuse potential of its proposed pain pill called Zohydro ER, a long- acting version of hydrocodone, an ingredient typically used in short-acting combination products that are meant to be taken every four-to-six hours. Agency staff noted that Zohydro doesn't contain any abuse-deterrent features to stop people from tampering with the pill to get the hydrocodone out immediately rather than being released over an extended period of time. The product is due be reviewed Friday. Comment! [Healthcare, On the Move]
    5 Dec 2012, 01:59 PM Reply Like
  • H. T. Love
    , contributor
    Comments (19388) | Send Message
     
    (NVAX)" "Novavax' Phase I RSV Vaccine Data Published in Vaccine"

     

    http://bit.ly/SD8fhA

     

    HardToLove
    7 Dec 2012, 09:01 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Zogenix (ZGNX) stock is halted today as FDA panel debates recommendation for approval..
    7 Dec 2012, 12:35 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Another one shot down....amazing! I really thought this was a lock for approval.

     

    WASHINGTON, Dec 7 (Reuters) - A U.S. Food and Drug Administration panel of outside experts voted against recommending Zogenix Inc'S Zohydro painkiller for FDA approval on Friday, citing concerns about the opioid drug's potential to cause addiction.
    7 Dec 2012, 04:44 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    After pulling drugs and scrapping them, who knows what to believe?

     

    9:34 AM Geron (GERN) soars 15.1% after saying that its imetelstat treatment performed well in Phase II trials of patients with a chronic blood disorder called essential thrombocythemia. Geron designed the trial to provide a proof of concept for the potential use of imetelstat to treat blood cancers. Geron shares were slammed last week after it said it was stopping the development of therapies for brain cancer. (Presentation) [Healthcare] Comment!
    10 Dec 2012, 05:55 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Now Geron is trading back up....unreal. They have one drug left with potential and hoping for a buyout according to article on SA.
    18 Dec 2012, 03:22 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    I said this drug should have been approved....now 2 days of hearings? I am willing to bet they get it approved with limited use and labeling warnings. I really beleive the committee was sending a message to Pharma's that the FDA wants abuse addressed from the beginning.

     

    3:17 PM Zogenix (ZGNX +8.1%) moves up today after saying the FDA has scheduled two days of hearings February 7-8 after receiving "comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain." Last week A panel of non-FDA medical experts shot down ZGNX's Zohydro, a hydrocodone pill for chronic pain. Hydrocodone is a semi-synthetic opioid derived from either codeine or thebaine. Comment! [Healthcare, On the Move]
    18 Dec 2012, 03:23 PM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Vertex had really bad news on Incivek causing "fatal skin reactions" a few patients died. This was partially offset with Europe news on it's new Cystic Fibrosis drug....Go read the news, VRTX is a short if I ever seen one. IMO. Do your own DD.

     

    1:47 PM Piper Jafrfray says Vertex's (VRTX -0.6%) Incivek sales are likely to decline further after the FDA forced the drug developer to place a warning regarding fatal and non-fatal serious skin reactions on the boxes containing its HCV treatment. The firm maintains a Neutral rating on the stock. [Healthcare] Comment!
    19 Dec 2012, 03:41 PM Reply Like
  • Mayascribe
    , contributor
    Comments (11197) | Send Message
     
    Researchers find gene that can predict time of death!

     

    http://bit.ly/VoGg7B
    29 Dec 2012, 07:00 PM Reply Like
  • FocalPoint Analytics
    , contributor
    Comments (6282) | Send Message
     
    Author’s reply » Here is the link to the new concentrator for 2013:
    http://tinyurl.com/a59...
    3 Jan 2013, 07:19 AM Reply Like
  • LT
    , contributor
    Comments (5783) | Send Message
     
    Zogenix out with multiple news releases this morning, most important is a new offering to raise capital.
    Also some sales and guidance info.
    Sorry can't post a link from here.
    7 Jan 2013, 10:01 AM Reply Like
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