Seeking Alpha

FocalPoint Anal...'s  Instablog

FocalPoint Analytics
Send Message
I own and operate an analytical services/ research company.
My book:
The Internet in Everyday Life (Chapter 19)
  • Swine Flu AND Medical News Concentrator August 28, 2013 To November 8, 2013 230 comments
    Aug 28, 2013 12:57 PM

    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.


    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.

    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.

    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.

    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.

    Brief Overview of Categories of H1N1/ Vaccine Investment Plays:

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

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

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

    Link to 2011 H1N1 US Flu Outbreak Map is broken... sorry.

    Red Cross Tips For Dealing With The Flu:

    * 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.

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

    Click here to link to the Mayo tool:

    Suggested Protocol For Schools To Decide When Flu Should Trigger A Shutdown

    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

    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 (230)
Track new comments
  • Author’s reply » Link to old concentrator:
    28 Aug 2013, 12:59 PM Reply Like
  • Thanks, Ratso!


    Latest on MERS:


    Second Qatari case:


    41st Saudi death:
    28 Aug 2013, 01:18 PM Reply Like
  • Great idea, FPA...the link to the previous Concentrator.


    Come back to me Novavax, I want to add more.
    28 Aug 2013, 02:10 PM Reply Like
  • (ASTX) up 7% for me today bot at $6.45 to $6..92 at 14:00
    28 Aug 2013, 02:09 PM Reply Like
  • Honduras continues to get rampaged by dengue fever. Now, 27,000 cases have been reported in Costa Rica.


    30 cases of swine flu have popped up in Peru.
    28 Aug 2013, 05:20 PM Reply Like
  • Maya: NVAX is working on a vaccine for dengue too. I forget who with though - maybe it was their partner in India.


    Anyway, in a couple years, or less hopefully, it will be available and those folks will have less misery.


    29 Aug 2013, 07:31 AM Reply Like
  • HTL: Yes, I'm aware of that. I believe (?) Sanofi Aventis is working on a dengue fever vaccine as well. That's one stock I wish I had not sold to buy my home.


    In Honduras, in 2010, one of those drop-down, white striped-nosed mosquitoes landed on my left forearm. Haven't swatted at anything that fast since.
    29 Aug 2013, 05:33 PM Reply Like
  • MannKind (Nasdaq: MNKD) is lower at the start following a few insider sales disclosed Wednesday night.
    According to Form 4s filed with the U.S. SEC:VP and General Counsel David Thomson sold 9,204 shares on August 26th and 10,000 shares on August 28th. Following the sales, Thomson holds 40,082 shares directly.
    Corporate VP Juergen Martens sold 20,000 shares on August 26th following exercise of an Employee Stock Option. The exercise price was $2.41, while the average sales price was $5.5204 per share. Martens has 136,016 shares held directly following the exercise and sale.Wednesday's disclosure follows a slew of insider activity last week.
    Shares of MannKind are down 0.4 percent Thursday.
    Copyright 2013, Street Insider News Provided by Acquire Media Corporation
    29 Aug 2013, 09:42 AM Reply Like
  • According to the Vickers Insider Prophets Report available through my Schwab account, those (MNKD) insider sales are essentially meaningless. They were "non-open market" sales, of less than 2% of the holdings of most of the insiders that sold some shares last week through the options plan. Hardly newsworthy, but required reporting to SEC.


    Name, Title Transaction
    During 2013 # of Shares Price($) Type % of Holdings Traded Now Holds
    Edstrom, Hakan, PR Sold 08/19 7,583 5.77 Direct, Non Open Market 1.29 582,424
    Martens, Juergen, VP Sold 08/19 2,274 5.77 Direct, Non Open Market 1.64 136,016
    Palumbo, Diane, VP Sold 08/19 2,350 5.77 Direct, Non Open Market 2.21 103,756
    Pfeffer, Matthew J., CFO Sold 08/19 2,350 5.77 Direct, Non Open Market 2.92 78,108
    Thomson, David, GEN CNSL Sold 08/19 2,350 5.77 Direct, Non Open Market 3.84 58,919
    Edstrom, Hakan, PR Sold 08/18 7,141 5.77 Direct, Non Open Market 1.19 593,186
    Martens, Juergen, VP Sold 08/18 1,618 5.77 Direct, Non Open Market 1.16 138,290
    Palumbo, Diane, VP Sold 08/18 1,551 5.77 Direct, Non Open Market 1.44 106,106
    Pfeffer, Matthew J., CFO Sold 08/18 1,598 5.77 Direct, Non Open Market 1.95 80,458
    Thomson, David, GEN CNSL Sold 08/18 1,551 5.77 Direct, Non Open Market 2.47 61,269
    Edstrom, Hakan, PR Sold 08/16 7,704 6.64 Direct, Non Open Market 1.27 597,148
    Martens, Juergen, VP Sold 08/16 1,703 6.64 Direct, Non Open Market 1.20 139,908
    Palumbo, Diane, VP Sold 08/16 1,598 6.64 Direct, Non Open Market 1.46 107,657
    Pfeffer, Matthew J., CFO Sold 08/16 1,598 6.64 Direct, Non Open Market 1.91 82,056
    Thomson, David, GEN CNSL Sold 08/16 1,645 6.64 Direct, Non Open Market 2.55 62,820
    29 Aug 2013, 10:21 AM Reply Like
  • I had an article ddt. today on (MNKD) here but pulled it.
    After a thorough read it wasn't adding anything to what we already know.
    29 Aug 2013, 05:16 PM Reply Like
  • i seen it too. At least that guy was more upbeat.
    29 Aug 2013, 05:27 PM Reply Like
  • NVAX was up nice today.
    29 Aug 2013, 05:28 PM Reply Like
  • if this is true, they have a blockbuster:


    Isis heart drug helps cuts blood fat in trial
    Isis' (ISIS) ISIS-APOCIIIRx reduced levels of triglycerides in blood by up to 75% and of apolipoprotein C-III by 79% in a Phase II study of 28 patients.
    Triglycerides are a type of fat that raises the risk of heart disease, while apolipoprotein C-III prevents triglycerides from being cleared.
    Patients also enjoyed increases of up to 57% in high-density lipoprotein (HDL), or "good," cholesterol.
    ISIS-APOCIIIRx is based on Isis' antisense technology, which inhibits cells from producing proteins that cause diseases. (PR)
    2 Sep 2013, 10:37 AM Reply Like
  • Novavax to Present RSV Vaccine Clinical and Preclinical Results at ICAAC


    ROCKVILLE, Md., Sept. 3, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) a clinical-stage biopharmaceutical company creating novel vaccines based on recombinant nanoparticle technology, today announced that it will present data from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver Colorado, September 11-13, 2013.
    One poster will describe in detail the immunogenicity and safety of Novavax' RSV F nanoparticle vaccine observed in a Phase 1 clinical study of 220 healthy elderly adults (≥60 years of age, mean age of 68 years of age), top-line results of which were reported by Novavax in July. The second poster will present data from a preclinical passive immunization and challenge study which evaluated the protective effects of RSV F nanoparticle vaccine-induced palivizumab-like antibodies in a relevant model, the cotton rat, which was previously predictive for protection in infant passive immunization studies.
    The poster presentation numbers, titles, dates and times are listed below:
    Poster B-501d: "RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders" will present data from the company's recently completed Phase 1 clinical trial of its RSV vaccine candidate in healthy elderly adults. [Exhibit Hall A, Wednesday, September 11 from 11:00am to 1:00 pm]


    Poster B-501a: "Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge" [Exhibit Hall A, Wednesday, September 11 from 11:00am to 1:00 pm]
    About RSV
    RSV is a major respiratory pathogen in all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11,000 to 17,000 adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. Currently, there is no approved RSV prophylactic vaccine available.
    About Novavax
    Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using Innovative proprietary recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website,
    Forward-Looking Statements
    Statements herein relating to the future of Novavax and its ongoing development of its recombinant nanoparticle vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and Form 10-Q for the period ended June 30, 2013, both filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place considerable reliance on forward-looking statements contained in this press release and encouraged to read the Company's filings with the SEC, available at, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and Novavax undertakes no obligation to update or revise any of the statements. Novavax' business is subject to substantial risks and uncertainties, including those referenced above and investors, potential investors, and others should give careful consideration to these risks and uncertainties.
    CONTACT: Barclay Phillips
    SVP, Chief Financial Officer and Treasurer
    Novavax, Inc.
    Source: Novavax, Inc.
    3 Sep 2013, 08:52 AM Reply Like
  • Also on

    3 Sep 2013, 11:01 AM Reply Like
  • Japanese health ministry wants H7N9 vaccine to be made, but no mention yet which producers will do so.

    3 Sep 2013, 11:03 AM Reply Like
  • >SM-


    Re: Japan vaccinations- Will it just be Japan or are Taiwan and PRC also embarking on programs to vaccinate?


    3 Sep 2013, 06:50 PM Reply Like
  • Added some more CYTK this afternoon at firesale prices.


    Thanks, Adam F.
    3 Sep 2013, 03:16 PM Reply Like
  • Here is a good but rather technical explanation of why the news and Adam F have no clues about the value of this drug. This was a dose finding study, and dyspnea relief was not the most relevant endpoint in severely ill hospitalized patients in acute heart failure:



    The patients enrolled in ATOMIC-AHF had a history of heart failure and reduced injection fraction [sic, should be "ejection fraction," the measure of how much of the blood volume of the left ventricle gets pushed into the aorta when it contracts] within injection fraction less than or equal to 40%. They were all hospitalized for acute heart failure requiring intravenous therapy with dyspnea due to heart failure at rest or minimal incursion despite the administration of an intravenous diuretic.


    In addition they do have to have elevations in their B&P or MT pro-B&P. While this study was a Phase II dose finding study, we also investigated and evaluated some efficacy primary endpoint was selected to be dyspnea symptom response through the first 48 hours. We have a multiple secondary efficacy endpoints selected, as well as evaluation of PK, PD from this eco sub-study [sic, echocardiogram, not "eco"].


    And now I'd like to present the actual results of the trial. 613 patients were enrolled in ATOMIC-AHF and they had characteristics consistent with patients who were admitted for acute heart failure with reduction in systolic function. They had a high prevalence of ischemic heart disease as well as multiple other co-morbidities.


    In addition patients enrolled in this trial had excellent background therapy for their chronic heart failure and despite an exclusion criteria which we excluded patients with clinical ACS or acute coronary syndromes.


    We had over half of the patients with troponins that were above the upper reference limit. In addition, the NT-proBNP in the 9,000 to 10,000 range is among the highest observed in any acute heart failure study. The primary efficacy endpoint consisted of evaluation of the dyspnea response using a seven level Likert scale. Ranging from markedly worsen to markedly improved.


    A patient was considered responder if they met the following criteria which was that they were minimally moderately or markedly better at six hours and moderately or markedly better at 24 and 48 hours without worsening of heart failure or death for any cost by 48 hours. So these are the primary results of the initial analysis of the ATOMIC-AHF trial. And in this figure you can see an increase in the dyspnea response rate from 42% in cohort 1 up to 51% in cohort 3 this 51% represents a 23% increase in treatment effect compared to the pulled placebo group. group to all of the omecamtiv mecarbil cohorts was not statistically significant with the P value of 0.33. A pre-specified supplementary analysis to the primary endpoint evaluated the paring of the placebo with the omecamtiv mecarbil from the same cohort.


    Within this analysis we can see that the placebo response rate among patients in cohort three was 37%, while among the omecamtiv mecarbil treated patients in cohort three the response rate was 51%. This represents a 41% improvement in treatment effect in the omecamtiv mecarbil group in the third cohort with a nominal p value of 0.03.
    3 Sep 2013, 03:32 PM Reply Like
  • >SM-


    Re: (CYTK)


    I liked it before and with your positive comments I like it again!


    Bot Stock and Opts.
    3 Sep 2013, 03:54 PM Reply Like
  • IT will be a roller coaster short-term. But I am in it for the long-term, when tirasemtiv gets to market for ALS and mysthenia gravis. That could be a five year plus horizon.


    The omecamtiv data for acute heart failure are just icing on the cake for me. These data clearly support moving into Phase III trials using the higher doses from the Phase II study.
    3 Sep 2013, 04:01 PM Reply Like
  • Smith agrees.

    4 Sep 2013, 08:18 AM Reply Like
  • A good summary of why the street pundits have got it wrong on CYTK:

    4 Sep 2013, 09:10 PM Reply Like
  • China diabetes hits 114 million....shows the mkt. potential for MNKD if they get their act together.

    4 Sep 2013, 07:16 AM Reply Like
  • (CYTK)


    $7.50s of October up 30% o'nite.
    Stock at $8.27, up $.62 at 10:20.
    4 Sep 2013, 10:19 AM Reply Like
  • I sold NVAX 4/14 $5 Calls @ .66
    4 Sep 2013, 10:27 AM Reply Like
  • >OG-


    Re: NVAX Calls-


    I tried to sell 6s and couldn't find enough interest.
    4 Sep 2013, 07:24 PM Reply Like
  • I tried with the $6's too, but it didn't budge, so I went to the $5.
    I only sold six. I'm testing the waters because it is hardly traded. I was going to start with 10 contracts. We'll see if it gets more enticing.
    4 Sep 2013, 11:48 PM Reply Like
  • Is there a reason why you are selling calls at $5 that is 12-18 months out?


    I would think if any contracts are won, NVAX could go north of $5


    Maybe I'm too optimistic
    5 Sep 2013, 05:16 AM Reply Like
  • LT-It's only 7 months out, not 12-18 months. We're in September. These are April calls.
    Do I think NVAX will be above @ $5.66 by the third week in April?
    I doubt it. But, if it is, I will gladly have the shares called away, because I have more and that would be a very nice profit.
    If the stock is below $5.66, it gives me a .66 cent cushion for the next two quarters. How long have you waited for the stock to move .66, much less the $1.75 from the present share price to that strike price? I thought it was a pretty good deal.
    I know that some analysts expect it to go to $11.00. That would be lovely. And, sometimes stocks gain insane momentum. But, this is biotech/Pharma. They still have phases and phases to go in their testing for approvals.
    I know you keep hoping that they will be fast tracked. We just can't count on that. In fact, with all of the issues (real and imagined) with vaccines, I don't see why the government would take that chance.
    5 Sep 2013, 11:26 AM Reply Like
  • sorry, I thought I read 2015 calls. I understand your point. I would take that if I owned more, but think I will just sit tight for now.


    I need to up my stake, but can't get the pull back i want.
    5 Sep 2013, 11:37 AM Reply Like
  • Be patient, LT. I feel certain we are going to see a market correction that will take NVAX down temporarily, along with the rest of the market!
    5 Sep 2013, 11:39 AM Reply Like
  • >LT-


    (NVAX) is at $3.13 right now. OGs $.66 in premium income gives her a good chance of keeping the money if NVAX doesn't get to $5.


    If it does get to $5 and she has to either buy or tender the shares the premium she already got is hers anyway assuming an insignificant trade cost to tender stock/money. If the stock should approach $5 she could always buy in the call at a lot less than she received. Look at as a $3.13 investment for which you get a $.66 return for 7 months, or a 21% return or 32%annualized.


    Not bad-


    The downside is that she must keep either the stock or equivalent $
    available should the stock get called- Ties up a bit of money.
    BTW- the Call is only 7 months out- Sept 2013 to April 2014


    Worst case situation is that the stock tanks and she needs to sell- She needs to buy in the Call at that time as well- Insult to injury.




    LOL! OG I didn't see your similar post!
    5 Sep 2013, 02:03 PM Reply Like
  • Thanks WT-- 8 months, not 7. I can't count!
    5 Sep 2013, 02:14 PM Reply Like
  • You were right the first time- My post before the edit said "8 mos" - I was wrong- it's seven.


    I'm trying to sell the same Calls now- 20 @ $.65.
    249 contracts Bid at .55
    20 (mine) at Ask .65


    Will see if I catch it before close.
    5 Sep 2013, 03:16 PM Reply Like
  • No go on the Call sell for NVAX 5s of 4/14- I'm thinking a SHORT TERM pop to the upside for the market in the next day or two. Market is TOO pessimistic.
    5 Sep 2013, 07:16 PM Reply Like
  • (ASTX) up over $2.00 - 31% at 13:20
    4 Sep 2013, 01:22 PM Reply Like
  • Sold the ASTX @ $8.47 Held only five days Bot at $6.45
    Sold the SDRL @ $45.98 Long time hold- Bot at $40.5
    Sold the CYTK $7.50s October @ $1.50- Bot at $1.00
    Sold the VLCFF 7.5s Dec @ $1.65 Bot at $.90


    All quite profitable, leaving a bit of red ink and some black as to what I still have left. Many orders open right now.
    5 Sep 2013, 03:24 PM Reply Like
  • Zogenix (ZGNX) is trading up from the $1.50's to $1.90 now....must be some news coming soon on whether their pain drug gets approved or denied.
    5 Sep 2013, 07:10 AM Reply Like
  • ZGNX closed @ $1.86 on 446,800 volume.


    No apparent news that I see.
    5 Sep 2013, 04:15 PM Reply Like
  • I havn't seen news either, but it's been steadily grinding up for a month now more or less.
    5 Sep 2013, 09:44 PM Reply Like
  • Otsuka will offer $8.50 a share for Astex, a 27% premium over the Dublin, California-based biotechnology company’s $6.68 closing stock price on Sept. 3, before the deal was reported. Astex surged 24 percent to a nine-year high of $8.27 at the close in New York yesterday after the Nikkei newspaper said Otsuka planned to buy it for 90 billion yen ($900 million).
    5 Sep 2013, 07:15 AM Reply Like
  • anyone close to Boston ?


    ROCKVILLE, Md., Sept. 5, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that Stanley C. Erck, President and Chief Executive Officer, will present at the 2013 Stifel Nicolaus Healthcare Conference on Thursday, September 12, 2013 at 9:45 a.m. ET in Boston, MA at the Four Seasons.
    5 Sep 2013, 08:45 AM Reply Like
  • ROCKVILLE, Md., Sep 03, 2013 (GLOBE NEWSWIRE via COMTEX) -- Novavax, Inc. a clinical-stage biopharmaceutical company creating novel vaccines based on recombinant nanoparticle technology, today announced that it will present data from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver Colorado, September 11-13, 2013.


    One poster will describe in detail the immunogenicity and safety of Novavax' RSV F nanoparticle vaccine observed in a Phase 1 clinical study of 220 healthy elderly adults (greater-than or equal to60 years of age, mean age of 68 years of age), top-line results of which were reported by Novavax in July. The second poster will present data from a preclinical passive immunization and challenge study which evaluated the protective effects of RSV F nanoparticle vaccine-induced palivizumab-like antibodies in a relevant model, the cotton rat, which was previously predictive for protection in infant passive immunization studies.
    5 Sep 2013, 09:14 AM Reply Like
  • Just my luck ... lol


    BofA downgrades MannKind
    BofA downgrades MannKind (MNKD) to Underperform.Price objective cut to $5.
    6 Sep 2013, 07:09 AM Reply Like
  • Trouble may be brewing for Osiris after MiMedx FDA letter: Feuerstein
    MiMedx's (MDXG) recent issues with the FDA "might portend trouble" for Osiris Therapeutics (OSIR), theStreet's Adam Feuerstein writes, in response to a reader's e-mail inquiry.
    MDXG "believed it could sell AmnioFix and EpiFix as HCT/P products" but the FDA apparently considers them to be "biologic products" which means they "must undergo review for efficacy and safety just like other drugs," Feuerstein says.
    The problem for OSIR: "Grafix and Ovation are HCT/P products [and] MDXG is raising a stink about competitors, insisting FDA take a closer look at their products which may also violate the HCT/P manufacturing guidelines."
    A little less than a month ago, OSIR shares took off after Grafix performed well in a study of patients with diabetic foot ulcers.
    6 Sep 2013, 07:56 AM Reply Like
  • (VICL) and (NVAX) each up 4% Friday
    (INO) up 15%
    8 Sep 2013, 04:20 PM Reply Like
  • Isis inks antisense deal with Biogen
    Isis Pharmaceuticals (ISIS) jumps 9.2% premarket after announcing a strategic collaboration with Biogen (BIIB) to develop treatments for neurological disorders using ISIS' antisense technology.The terms of the six-year deal given BIIB exclusive rights to ISIS' technology and call for an upfront payment to ISIS of $100M.ISIS is eligible to receive up to $220M in milestone payments on antisense molecules and may also receive additional funds to cover the costs of clinical trials.The upfront payment will be charged to R&D expense for BIIB in Q3. (PR)
    9 Sep 2013, 08:34 AM Reply Like
  • There may be a treatment for MERS. At least in lab monkeys.





    plus interferon alfa 2b


    Original Nature Medicine article:
    9 Sep 2013, 11:09 AM Reply Like
  • Sagent Pharmaceuticals slips on announcement of 4.4M share offering
    Sagent Pharmaceuticals (SGNT -9.2%) slides after announcing a 4.4M share offering.
    The company will be offering 3,384,097 shares and other selling shareholders will sell 1,057,530 shares.
    The underwriters will have a 30-day option to purchase up to an additional 666,244 shares as needed.
    The company intends to use the net proceeds for general corporate purposes.
    9 Sep 2013, 02:19 PM Reply Like
  • Roche signs licensing deal for two Inovio vaccines
    Roche has signed a deal to exclusively license two Inovio Pharmaceuticals (INO) vaccines - INO-5150 for prostate cancer and INO-1800 for hepatitis B, both of which are in pre-clinical development.Roche will pay $10M up front, milestones of up to $412.5M, and double-digit tiered royalties on any product sales.Inovio's vaccines have shown that they can induce the immune system's T cells in animal models to fight disease.The Swiss company will also gain access to Inovio's electroporation technology, which is used to administer the vaccines.Inovio shares soar 33% premarket, Roche +1% in Zurich. (PR)
    10 Sep 2013, 08:29 AM Reply Like
  • Somethings up...


    Zogenix traded 2.24 today briefly, and volume is over 2 million shares.
    10 Sep 2013, 03:12 PM Reply Like


    Nothing new, but NVAX reported good results in RSV at one of the conventions
    11 Sep 2013, 09:29 AM Reply Like
  • (VICL) up over 6% at 11:00- Presenting at NY Health care conference at 11:25.
    Something up?


    Presentation here:
    11 Sep 2013, 11:13 AM Reply Like
  • Scientists turn back time in living mice
    On Wednesday, a study published in the journal Nature, showed scientists were able to reprogram mature cells in mice, effectively "turning back the hands of time" (to use Bloomberg's expression), and forcing the cells to revert to a form of stem cell which can differentiate into other kinds of cells.Incredibly, the reprogrammed induced pluripotent stem cells ((iPS)) showed more potential — in terms of their ability to change into different cell types — than either embryonic stem cells or normal iPS cells.
    The idea is that scientists may one day be able to regenerate damaged tissue inside a patient's body. Previously, researchers had only demonstrated the ability to forcibly reprogram the cells in petri dishes. (more here)
    13 Sep 2013, 04:26 AM Reply Like
  • Amazing is the right word-


    Imagine what that would mean for nerve damaged paraplegics, other spinal cord damage injuries as well as for stroke victims.


    Unlimited possibilities, I suppose.
    20 Sep 2013, 01:26 PM Reply Like
  • U.S. companies working on 271 vaccines
    U.S. bio-pharmaceutical companies are developing 271 vaccines to prevent and even treat numerous conditions, a report from the Pharmaceutical Research & Manufacturers of America says.The conditions targeted include infectious diseases and various forms of cancer and neurological disorders.In the U.S., 10 infectious diseases have been at least 90% eradicated because of vaccines.
    13 Sep 2013, 04:26 AM Reply Like
  • Logo
    Novavax Highlights Positive Results From Partner's Clinical Trial of Vaccine Using Matrix-M(TM)


    Genocea Biosciences' Herpes Simplex Therapeutic Vaccine uses Matrix-M adjuvant
    Phase 1/2A U.S.-based clinical trial enrolled 143 volunteers with moderate-to-severe HSV-2
    Two highest dose Matrix-M adjuvanted cohorts demonstrated statistically significant reductions in viral shedding
    Genocea's Phase 2 planned for 2014
    ROCKVILLE, Md., Sept. 13, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported that its partner, Genocea Biosciences Inc., announced positive, interim topline data from a Phase 1/2A clinical trial of its lead candidate, GEN-003, a first-in-class investigational protein subunit vaccine for patients with moderate-to-severe herpes simplex virus type 2 (HSV-2) infection. Genocea's herpes simplex virus-2 therapeutic vaccine candidate uses the Novavax proprietary adjuvant known as Matrix-M.
    Genocea's results showed that vaccination with GEN-003 potentiated by the Matrix-M adjuvant can significantly blunt HSV-2 infection and reduce viral shedding. The two highest dose cohorts, both adjuvanted with Matrix-M, demonstrated significant reductions in viral shedding (51% and 30%, respectively, each p<0.001). No serious adverse events were related to the vaccine.
    The partnership agreement with Genocea covers the use of Matrix-M in the development of vaccines against specific diseases including herpes simplex virus type 2.
    "The strong showing of Genocea's vaccine candidate, which includes our proprietary adjuvant Matrix-M, underscores the potential of the adjuvant to Novavax, and the value of our recent acquisition of Isconova," said Stan Erck, President and Chief Executive Officer of Novavax.
    "The early clinical response to GEN-003 in this trial is unprecedented in HSV-2. We are proud to be pioneers in the field of T cell-directed vaccines," noted Chip Clark, President and Chief Executive Officer of Genocea.
    To read Genocea's published press release, follow the link:
    About Matrix-M™
    Matrix-M is a patented vaccine adjuvant being developed and produced by Novavax . Adjuvants enhance the efficacy of a vaccine while maintaining safety; they increase the vaccine's ability to produce antibodies and induce a cellular response that is important for modern vaccines.
    About HSV-2
    Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide, and one out of six people aged 14 to 49. In the U.S., an estimated 50-60 million people are affected. HSV-2 infection can cause recurring, painful genital sores and, due to the stigma associated with this disease, can impact patients' ability to form and maintain relationships, resulting in considerable psychological distress in patients. No vaccine is currently approved to prevent or treat the disease.
    About Genocea Biosciences
    Genocea Biosciences is harnessing the power of T cell immunity to develop the next generation of vaccines. T cells are increasingly recognized as a critical element of a protective immune response to a wide range of infectious disease pathogens, but are difficult to target using traditional vaccine discovery methods. Genocea is uniquely able to identify protective T cell antigens in humans exposed to a pathogen using ATLAS™, its proprietary technology platform that mimics the human immune response in the laboratory, potentially improving the effectiveness of vaccine candidates and drastically reducing the time needed to create them. Genocea's pipeline of novel T cell vaccines includes GEN-003 for HSV-2 therapy, GEN-004, a protein vaccine directed at pneumococcus that is expected to enter the clinic in the fourth quarter of 2013, and earlier-stage programs in chlamydia, HSV-2 prophylaxis and malaria.
    About Novavax
    Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, and PATH. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website,
    Forward-Looking Statements
    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and Form 10-Q for the period ended June 30, 2013, both filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
    CONTACT: Barclay Phillips
    SVP, Chief Financial Officer and Treasurer
    Novavax, Inc.
    Source: Novavax, Inc.
    13 Sep 2013, 10:11 AM Reply Like
  • Author’s reply » 51 and 30%.... those are huge effect sizes. That's great!
    13 Sep 2013, 10:37 AM Reply Like
  • If this gets approved, it is a huge market. There is a high % of the population worldwide involved.
    13 Sep 2013, 11:13 AM Reply Like
  • Don't get too excited yet. It's still early in the studies.
    13 Sep 2013, 11:16 AM Reply Like
  • It is good news, but "blunting" infection and reducing viral shedding, while it may reduce the overall pain and morbidity associated with HSV-2, is by no means a cure and we do not really know if it will reduce infectious transmission.


    Good news for suffering patients, if it ameliorates the discomfort associated with the disease.


    But the old joke about differences between Herpes and love is still true. Love is fleeting and Herpes is for life!
    13 Sep 2013, 12:22 PM Reply Like
  • NVAX to update all programs


    ROCKVILLE, Md., Sept. 17, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today announced that it will host the Analyst and Investor Update Call with Webcast on Tuesday, September 24, 2013, from 9:00 a.m. - 11:00 a.m. (EDT).
    17 Sep 2013, 09:04 PM Reply Like
  • Sangamo BioSciences to offer shares, stock falls
    Sangamo BioSciences (SGMO) announces a planned public offering.The size of the deal is not disclosed.There will be a 15% underwriter option. (PR)Shares -5.4% AH
    17 Sep 2013, 09:08 PM Reply Like
  • LT: Good timing by Sangamo, after their recent and promising HIV tests. Hopefully, this offering will bring the price down to an attractive add.


    Again, and for whatever this is worth, SGMO is my favorite biotech, which I believe has the highest, most profound potential of any biotech, after almost five years of investigating this sector.


    17 Sep 2013, 10:54 PM Reply Like
  • >LT-


    Re: (SGMO) and right back up almost 6% this morning following the 5.4% drop after hours yesterday.


    People must be reading Maya's comments!
    18 Sep 2013, 10:51 AM Reply Like
  • TheStreetSweeper sets sights on Sangamo BioSciences


    Anyone who owns Sangamo BioSciences (SGMO), might want to take a trip over to TheStreetSweeper and check out their piece entitled "A fiery biotech with a product poised to go down in flames?"
    The article questions the company's ZFN gene modification technology which is behind SB-728-T (see recent announcement of new data from Phase 2 trial).Senior investigative reporter Sonya Colberg says "TheStreetSweeper would be astounded if SGMO produces a marketable anti-HIV product — ever."Notably, Colberg also says "renowned HIV doctor" Joseph Sonnabend was consulted for the article and after reviewing "trial results and graphs," concluded that "no meaningful evidence was presented to indicate that [SGMO's] treatment has antiviral activity."
    20 Sep 2013, 04:55 AM Reply Like
  • LT: Whoa! Let me rewrite my above comment: SGMO is my least favorite biotech. :-{ !!!


    Here's the article you pulled your comment above from, which as soon as I link it will go over to my gamer account and sell my measly 25 shares...well, I didn't wait...sold them @$10.40. Bought them at $4.49. My balloon is popped!



    Thanks, LT!
    20 Sep 2013, 02:04 PM Reply Like
  • >LT-


    Re: (SGMO) Thanks for your comments.


    Just read the article by StreetSweeper- Pretty uncomplimentary for sure. In 18 years they have not brought even one drug to a Phase III stage? Wow


    I think that CEO that bailed out $200,000 worth of shares BEFORE the IPO announcement knew what he was doing.


    BTW, Is that legal?


    20 Sep 2013, 01:20 PM Reply Like
  • 3 Stocks that could triple, NVAX is one of them

    20 Sep 2013, 04:54 PM Reply Like
  • serepta

    23 Sep 2013, 09:45 AM Reply Like
  • Isis announces Phase 2 antisense data in FCS
    Isis Pharmaceuticals (ISIS) outlines data from a Phase 2 trial of the antisense drug ISIS-APOCIIIRx in familial chylomicronemia syndrome.All three patients saw "substantial reductions" (average was 69%) in triglyceride levels.The disease only affects 3-5K patients worldwide, so the trial was quite small, but the data "are ... compelling and demonstrate the potential of ISIS-APOCIIIRx to produce dramatic triglyceride lowering in patients with FCS," Dr. Daniel Gaudet notes.The company says "the significant unmet medical need [associated with FCS] should enable [ISIS to] rapidly move forward." (PR)
    23 Sep 2013, 11:18 AM Reply Like
  • Cardiome jumps on A-fib study data
    Cardiome (CRME +16.2%) soars after reporting positive data from an atrial fibrillation study.The company says patients treated with vernakalant "achieved conversion to normal sinus rhythm in a median time of 12 minutes compared to 151 minutes for propafenone and 162 minutes for flecainide." (PR)Recently: CRME inks vernakalant distribution deal
    23 Sep 2013, 02:29 PM Reply Like
  • Watch this stock, (CRME)


    For those who are unaware of the size of this mkt, Atrial Fib is a irregular heart beat. To stay away from the technical is an "Age related" disease. Meaning that it is common in most people as we age.
    With the boomers being >50% of the population this company has huge potential.


    Along with this is blood thinners that are less dangerous than Warfarin. They go hand in hand with A-Fib because the irregular heartbeat causes blood clots to form in the heart and when released is the major cause from a stroke.
    Merck dumped them last year because of no oral treatment Heres a decent article
    24 Sep 2013, 05:31 AM Reply Like
  • Goldman gets bullish on ResMed
    Goldman upgrades ResMed (RMD) to Buy from Neutral.Analyst Ian Abbott says the company will likely "deliver double-digit EPS growth in FY 2014 ... due primarily to strong patient demand, positive mix shift to higher-end devices and limited market share losses, if any."Abbott also says FX-tailwinds should serve to offset any drag from pricing declines.The FX and mix shift arguments are familia
    24 Sep 2013, 05:22 AM Reply Like
  • ROCKVILLE, Md., Sept. 24, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it has priced an underwritten public offering of 27,693,000 shares of common stock at a price of $3.14 per share, the closing price of the stock on the previous day, for gross proceeds of approximately $87.0 million. Novavax expects to receive net proceeds, after deducting the underwriting discount, of approximately $82.6 million from the offering. In connection with this offering, Novavax granted the underwriters a 30-day overallotment option to purchase up to an additional 4,153,950 shares of its common stock. Novavax intends to use the net proceeds of the offering for general corporate purposes, the advancement of its clinical-stage vaccine candidates and its pre-clinical research programs. The offering is expected to close on or about September 27, 2013, subject to the satisfaction of customary closing conditions.
    Lazard Capital Markets LLC is acting as the sole book-running manager for the offering. Piper Jaffray & Co. and Wedbush PacGrow Life Sciences are acting as co-lead managers and Burrill Securities LLC is acting as co-manager for the offering.
    24 Sep 2013, 08:13 AM Reply Like
  • Quadrivalent Seasonal Influenza Clinical Trial to start in 1Q2014
    Pandemic Influenza Clinical Trial to start in the U.S. in 1H2014
    Proprietary Adjuvant Matrix-M to be used in the Pandemic Clinical Trial
    ROCKVILLE, Md., Sept. 24, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that it is finalizing details on costs and timelines for their next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) following successful completion of process improvement studies. Novavax is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. The pandemic study will include the use of Novavax' proprietary saponin-based adjuvant, Matrix-M .
    "Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal," said Stanley C. Erck, President and Chief Executive Officer, "Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA's interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine program."
    About the Novavax BARDA Contract
    In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract's 3-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. Upon satisfaction of established milestones, the contract can expect to be extended for an additional 24 months, upon execution by BARDA of an Option One period, valued at $79 million in additional funding. The milestones under the Option One period would focus on completion of the pathway to product licensures from the U.S. Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million).
    24 Sep 2013, 08:14 AM Reply Like
  • Co is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. The pandemic study will include the use of Novavax' proprietary saponin-based adjuvant, Matrix-M.Copyright (C) 2010
    24 Sep 2013, 08:20 AM Reply Like
  • Author’s reply » Slick move timing the offering to the BARDA news. On top of that, the offering was at yesterdays close. That signals strength to me. I will be adding a bit today.
    24 Sep 2013, 11:43 AM Reply Like
  • I see it as strength too TB....I too will be adding soon. I was waiting and hoping for a capital raise pull back, but we may/may not get it.
    24 Sep 2013, 02:47 PM Reply Like
  • Dynavax jumps AH on HEPLISAV Phase 3 data
    Shares of Dynavax (DVAX) jump 5.9% AH after the company announces the previously published results of 2 Phase 3 trials of its HEPLISAV hepatitis B vaccine.Results from over 2,400 subjects aged 40-70 led the authors to conclude that the vaccine "induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) than the licensed comparator hepatitis B vaccine ... while maintaining a similar safety profile."The second trial in over 500 participants with chronic kidney disease determined that HEPLISAV provided "significantly higher seroprotection rates and earlier and more persistent seroprotection than the licensed conparator ... while maintaining a similar safety profile."
    24 Sep 2013, 05:06 PM Reply Like
  • Inovio talks monoclonal antibodies, DNA plasmid technology, shares rise
    Inovio Pharmaceuticals (INO) announces the publication of a peer-reviewed paper which outlines a study wherein the delivery of a DNA-based monoclonal antibody triggered the generation of antibody molecules "possessing desirable functional activity including high antigen-binding and HIV-neutralization capabilities against diverse strains of HIV viruses for at least 7 days" in mice.The company also notes the strategy "resulted in a rapid increase in antibody levels."CEO Dr. J. Joseph Kim says what makes him "particularly excited about this new published data is that, although early, the results clearly demonstrate the utility and potential of INO patented DNA plasmid and electroporation technology." (PR)INO +7% premarket.
    24 Sep 2013, 05:13 PM Reply Like
  • Author’s reply » Here is the link to the NVAX investor's call []
    24 Sep 2013, 06:40 PM Reply Like
  • Thanks Rattie! I've been a bit pushed since one of my nodes broke and am still recovering. I appreciate your posting the link here.


    24 Sep 2013, 06:45 PM Reply Like
  • Author’s reply » Did you loose any data / work HT?
    24 Sep 2013, 07:50 PM Reply Like
  • FPA: No. Had backed up just one day back and had the missing day on disks, just couldn't access it. Wrong parts sent on initial order so had to RMA and wait again for the correct adapter to be able to access the data. Got a little learning curve out of it though - don't use big-shop tools (LVM on *IX systems, e.g.) when "little-shop" tools (traditional partitioning which leaves each HD independent of others that might fail) will do the job. Alternatively, I can blend them but set up as for a little shop. That gives flexibility with fewer inter-dependencies.


    Right now I'm just catching up on EOD postings and then will have to replace the mainboard *again* (first one they sent was flaky as hello), but all the data is available and can be accessed from the mainboard that's in that node now (and it's no on my external b/u drives too). No networking on that one is all (for the moment - for a while it was failing to recognize all my memory and/or throwing false memory errors on the overnight memtest).


    24 Sep 2013, 08:11 PM Reply Like
  • Author’s reply » Great to hear you did not loose any work or data. That's the true sign of a Pro :)
    24 Sep 2013, 08:24 PM Reply Like
  • Author’s reply » (NVAX):
    We have all been following NVAX for many years now. I felt their fast vaccine development process would revolutionize the industry. Over the years, my initial enthusiasm waned as I felt NVAX management was more comfortable remaining as a small R&D company as opposed to taking advantage of what I believe was its revolutionary manufacturing advantage and growing into a company willing to commercialize it's products. I interpreted the company’s collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH as signs that the company was delegating commercialization and the primary revenue streams associated with commercialization to those partners. And there things stood for years.


    Than, in July, the company did something unusual. It acquired Isconova, a company specialized in developing and commercializing adjuvants and vaccines. Given the recent history of negative news about adjuvants, I interpreted this as a defensive move to insure the company had sufficient in-house expertise in adjuvants, a vital component of many vaccines. I overlooked Isconova's commercializing expertise.


    On September 17, NVAX announced it would host an Analyst and Investor Update Call on September 24th. This was the first time NVAX had hosted an Analyst's call, so clearly something was up. I increased my holdings a bit. I was really looking forward to reading about that call yesterday (Tuesday) when across the screen came the news that NVAX had announced an $87M offering at the PREVIOUS DAYS CLOSING PRICE. I was drinking a cup of tea at the time, and my reaction was akin to someone sticking a pin in me. A big dilution offered at zero discount? I checked the price, and got another surprise, the price was moving up!


    I consider a big offering with a zero discount and the price moving up as a signal of real strength, so I immediately substantially increased my holdings with a 'no look' buy.


    Yesterday afternoon, the text of the Analyst's call was released, and there it was - the company appears to be finally moving into another development phase and needed the funds for expansion.


    I encourage everyone to read the Analyst's conference call. [] It's tough sledding, but after reading it, I think you will be impressed. We all have different backgrounds. I hope the more medically inclined readers post their impressions of the analyst's call.
    25 Sep 2013, 08:10 AM Reply Like
  • Thanks for that update FPA. I am watching for a starter position and was "hoping" for a dilution drop. And thanks to LT and all others for educating me on this small biotech opportunity.
    25 Sep 2013, 08:48 AM Reply Like
  • I am a fan of NVAX, and adding to my position. But IMO, we still get a pullback at some point. That is where I intend to be more aggressive in adding.


    Not negative, just a beware and caveat emptor.


    This mkt. is weak going into the weekend with the debt debate.
    25 Sep 2013, 09:39 AM Reply Like
  • Thanks for the NVAX update, FPA-


    I had totally forgotten about the update call on the 24th-


    The analyst evaluation is indeed encouraging but not a major price mover IMHO, rather an announcement of a sound investment.


    25 Sep 2013, 09:50 AM Reply Like
  • I read most of the conference call over coffee this AM, but did not finish it yet. It is really jargon dense, and the transcriptionist was clueless about some of the terminology, making it even harder to understand.


    The important gist that I have gotten so far is that the combination of proprietary adjuvant system and the recombinant technology make for a very promising approach to rapid vaccine development in a strain that is hard to develop vaccines for.


    See: First vaccine for H7N9 may be too little, too late


    H7 viruses don't provoke much of an immune reaction, though, meaning that six times as much virus could be needed as that put in seasonal flu vaccines. The global vaccine manufacturing capacity for flu vaccines is 4.54 billion doses per year, says Michael Osterholm of the University of Minnesota in Minneapolis. The swollen dose needed for H7N9 vaccines would cut that figure to 757 million – not much in a pandemic.


    So the NIAID is testing H7N9 vaccines with adjuvants, agents that stimulate the immune system, making smaller doses of virus effective. Adjuvants are already used in some flu vaccines in Europe, but the US has resisted authorising them because they are associated with more side effects. "The US Food and Drug Administration will decide what to do, depending on what data we get in the trials," says Bruce Gellin, head of the US National Vaccine Programme in Washington DC.


    Even with the adjuvants, it would take 17-22 weeks to grow and make a vaccine – and manufacturers will not switch from seasonal flu to pandemic vaccines until they are sure a pandemic is underway. "That means a vaccine will be too late, as it was in the last three pandemics," says Osterholm.


    So a recombinant synthetic approach instead of standard egg media growth could be faster.


    Novavax to Initiate Seasonal and Pandemic Influenza Trials in Collaboration With BARDA


    "Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal," said Stanley C. Erck, President and Chief Executive Officer, "Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA's interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine program."
    25 Sep 2013, 10:14 AM Reply Like
  • SMaturin: (NVAX) was one of two companies that delivered a prototype vaccine for H7N9 in just a few weeks from the time the identification of need occurred. Their VLP technology combined with bio-reactors that are single-use and cheap allowed this.


    They had done something similar before when the H5N1 outbreak came but they had no trials undr their belt at the time. They did get a trial completed in Mexico on a fast-track basis and ... the "pandemic" ended before any action could be taken in the U.S. towards testing or approval.


    At that time, they were punted by the FDA back to square one.


    My thought though is that the technology to make the vaccine is really proven already, but just not yet approved, which is as it should be I guess.


    I remember thalidomide babies in the news when I was a young man.


    25 Sep 2013, 12:01 PM Reply Like
  • They have the technology and have demonstrated rapid development for phase I/II trials.


    They will still need to complete Phase III trials to get a vaccine using this technology FDA-approved and marketed, unless they get some sort of fast-track status via CDC, WHO, or other agency to intervene when a pandemic begins.


    The conference call describes a vision of those P3 trials occurring in 2014, so they may not be in time for a 2013 pandemic of H7N9, should it occur.
    25 Sep 2013, 12:14 PM Reply Like
  • Author’s reply » Thanks Doc... One place I got lost was when they were talking about using a spectral analysis to determine how the manufacturing process was damaging genes in the vaccines. I am familiar with spectral analysis where you are looking at emission lines emitted when you burn something. I could not figure out how emission lines would tell you anything about gene damage.
    25 Sep 2013, 01:21 PM Reply Like
  • Mass spectrometry allows a chemist to identify the range of molecular entities in a sample by mass-to-charge ratio when the sample is ionized and accelerated through an electromagnetic field. It is just one of the tools available to analyze large molecular weight samples of organic molecules. It is a way of measuring the purity, for example.

    25 Sep 2013, 02:42 PM Reply Like
  • Author’s reply » Thanks for that link Doc...
    25 Sep 2013, 03:00 PM Reply Like
  • I knew something was going on with Zogenix up and the probable denial by the FDA for their pain med.


    * ZOGENIX INC , Tuesday close $1.89, up 9 pct after market
    The drugmaker was awarded a $20.7 million contract from a unit of the U.S. Department of Defense for various medical and surgical products. (
    25 Sep 2013, 09:38 AM Reply Like
  • Really good news regarding (NVAX). We've been waiting for a long time on this one. Galena Biopharma (GALE) Has made an offering as well. Price was only slightly affected. Has anyone else dipped a toe into this one?
    25 Sep 2013, 02:14 PM Reply Like


    NVAX would appear to be ready for a consolidation phase to form a new base near all-time highs for the stock. As such, I believe now is a good time to begin building a long term position in NVAX.


    insiders have bought over 300k shares on the open market in the past 12 months, and the company's market cap is markedly lower than what a successful RSV vaccine would be worth (i.e., billions)
    25 Sep 2013, 03:40 PM Reply Like
  • Pacific Biosciences soars 59% after development deal with Roche
    Pacific Biosciences (PACB +59%) will receive $35M upfront and expects another $40M in funding tied to development milestones. Once development is completed, the company expects to receive further income from the manufacture and supply of products Roche (RHHBY.OB +0.9%) will market.Roche: "We see great potential in Pacific Biosciences' sequencing technology for the development of future clinical sequencing applications."PACB: "We believe the combination of our SMRT Sequencing technology with Roche's market position and expertise in diagnostics will allow accelerated commercial success for both companies."Kudos to SA Pro's Stephen Simpson who just 3 months ago spotted Pacific Biosciences as a risky, but potentially explosive play at about half of today's price.Press release.
    26 Sep 2013, 05:49 AM Reply Like
  • Sarepta gives eteplirsen update
    Sarepta Therapeutics (SRPT) gives an update on Study 202.At 96 weeks, DMD patients treated with eteplirsen "showed a continued stabilization of walking ability ... on the 6-minute walk test." (PR)SRPT shares are off 3.6% premarket in what may be a "sell the news" event. Alternatively, investors could simply be experiencing a bit of SRPT fatigue following the 26% post-drisapersen data rally.
    27 Sep 2013, 05:47 AM Reply Like
  • Look at the number of bio=techs on this list of 10 stocks funds will be buying

    27 Sep 2013, 06:47 AM Reply Like
  • Sept 25 (Reuters) - Novavax Inc :
    * MLV & Co raises price target to $9.50 from $8.50; rating buy
    27 Sep 2013, 08:27 AM Reply Like
  • 5 Bio's with upcoming events to move the needle:

    27 Sep 2013, 08:48 AM Reply Like
  • John McCamant Scans Under The Radar For Promising Biotechs

    27 Sep 2013, 09:30 AM Reply Like
  • MNKD ... if you own it, read this (I was afraid of this when it got sold on the news so hard)


    Analyst Bart Classen of Summer Street said in a note that there is a "real" chance Mannkind Corporation's (NASDAQ: MNKD) NDA for Afrezza will not be accepted by the FDA when resubmitted. Summer Street does not have a rating on Mannkind, but Classen thinks it is unlikely inhaled insulin will be approved.
    Copyright 2013, Street Insider News Provided by Acquire Media Corporation
    27 Sep 2013, 09:45 AM Reply Like
  • I view such "analyst notes" as manipulative nonsense.


    It is a risky stock, but the chances of approval this time around are far greater than before.
    27 Sep 2013, 11:12 AM Reply Like
  • Can anyone give an opinion on the time frame for NVAX with all these $8.50 - 9.50 targets ?
    27 Sep 2013, 11:07 AM Reply Like
  • NVAX still needs to complete Phase III trials, so it is not in the immediate future.
    27 Sep 2013, 11:13 AM Reply Like
  • Are we talking a year, or 2 years ?
    27 Sep 2013, 11:32 AM Reply Like
  • LT, SMaturin et al.
    Very much appreciate your updates on NVAX. Took a starter position in it today. Aside from all the other research -- I was very impressed with the price stability after its latest dilution -- not to mention all of the general market jitters at the moment.
    27 Sep 2013, 12:41 PM Reply Like
  • In the transcript, Erck said, "So we have -- we're a company with late-stage development programs. We've progressed from Phase I into Phase IIs. Our expectation is, is that we will be developing our first Phase III program by the end of next year."



    There are many other catalysts that could pop the price between now and then, based on partnering or even potential buyout, but they have a great pipeline of potential vaccines that would not likely actually get FDA approval before 2015 or beyond.


    If your horizon is to invest for the long term, it remains an excellent prospect to buy now when it is cheap. If you want to trade it on the news, I would expect there to be continued volatility in the next couple of years as pundits alternately promote and bash it, like with MNKD and ACAD and AMRN and ARNA, which I still hold.
    27 Sep 2013, 01:25 PM Reply Like
  • thanks sm
    27 Sep 2013, 01:30 PM Reply Like
  • Doc: You nailed it. Us QuickChatters/Renegades, who have now been hanging together on SA for about 4.5 years, and have been following, trading, researching NVAX the whole time, all "likely" understand the 2015+ horizon.


    Mercy: Probably a good idea to start a small position today, especially because, as you wrote, of price stability post the offering. I have some shares I added a few months ago, and have them stowed away in my Mother Goose sock drawer.
    27 Sep 2013, 02:04 PM Reply Like
  • LT, it is several years away, unless they get a buy out offer from a larger company or there is some catalyst to move them faster ( in which case I would sell it when the news hits). This is a slow process. I remember you asked that a few months ago--They have not been fast tracked and they are in good shape financially since they just raised $100 Mil, (I got that email today). Phase 3, just like the other phases, takes place in stages and it all takes time.
    Not regarding NVAX: I read Credit Suisse stock reports sometimes, and they are projecting into 2015 now. they usually project out about 18 months. So, if the report you read doesn't give a time frame, ask the author.
    27 Sep 2013, 02:05 PM Reply Like
  • ROCKVILLE, Md., Sept. 27, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced the closing of its previously announced underwritten public offering of 31,846,950 shares of its common stock, including 4,153,950 shares of common stock that were issued upon the exercise in full of the over-allotment option granted to the underwriters.
    The shares were sold at the public offering price of $3.14 per share, resulting in total gross proceeds of $100 million dollars. Novavax will receive net proceeds, after deducting underwriting discounts and commissions and offering expenses, of approximately $94.6 million from the offering.
    27 Sep 2013, 11:32 AM Reply Like
  • Could immune cell discovery lead to universal flu vaccine?

    27 Sep 2013, 07:04 PM Reply Like
  • appears they are headed for some level of approval on their Zohydro ER pain drug.

    2 Oct 2013, 05:42 AM Reply Like
  • The biotech that tried to save Steve Jobs ... worth watching

    3 Oct 2013, 07:23 AM Reply Like
  • I was hoping this one would get hammered down with the DC stand off...but now the upgrades come.


    Wells Fargo upgrades PCYC


    Wells Fargo initiated coverage on Pharmacyclics (NASDAQ: PCYC) with an Outperform rating and a price target of $155-$160. Analyst Matthew J. Andrews discussed Pharmacyclics's Ibrutinib, calling it the next big think in blood cancer therapeutics.
    "PCYC's lead drug ibrutinib has generated significant clinician, regulatory, and investor attention based on some of the most impressive results reported to date in CLL, MCL, and other NHL sub-types, in our view. We believe ibrutinib has the potential to be Revlimid-, Rituxan-, or Gleevec-like in its global revenue trajectory and impact in treating various blood cancers, and see it becoming a backbone standard of care. While consensus expectations are high for ibrutinib s launch and PCYC s shares have appreciated about 130% in 2013 versus the BTK s 40%, long term we see PCYC as undervalued, due to ibrutinib's opportunities in multiple blood cancers," said Andrews.
    4 Oct 2013, 01:35 PM Reply Like
  • 2 new bio-techs with promise: mstx cris
    6 Oct 2013, 12:41 PM Reply Like
  • Thanks, LT -
    Borrowing SMaturin's phrase- Good material for the sock drawer?




    Been doing some research on NOVO NORDISK (NVO).


    FRom the WSJ-


    On September 25, 2013, Novo Nordisk A/S (Novo Nordisk) announced that recruitment for the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial assessing cardiovascular (CV) outcomes of Victoza, the once-daily GLP-1 analogue, resulted in a high-risk population with patient number exceeding the original target. The Company noted that the LEADER trial is the largest and longest clinical trial in Novo Nordisk's history, with data from more than 17,000 patient years of exposure collected to date. "Victoza(R) has a strong body of clinical evidence demonstrating its efficacy, both pre- and post-approval," said Dr. Steven P. Marso, Lead Investigator of the LEADER trial, and Professor of Medicine at Mid America Heart Institute at Saint Luke's Health System in Kansas City, Missouri. The Full Research Report on Novo Nordisk A/S - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: []


    It's been pretty ho hum for a while but there is a lot going on. The analysts have given this company the highest overall rating in pharms.


    Might be worth a look-


    7 Oct 2013, 06:11 PM Reply Like
  • Author’s reply » Oct. 7, 2013 Novavax (NVAX) announced that enrollment has begun in a Phase 2 dose-confirmatory clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age. []
    7 Oct 2013, 07:16 PM Reply Like
  • >FPA-


    Thanks for the NVAX info.


    I was wondering what kicked it up recently. Some pre-announcement stock movement I guess.


    8 Oct 2013, 08:57 AM Reply Like
  • WT you can enroll at the NVAX company website and they will send you each announcement as it occurs.
    8 Oct 2013, 01:32 PM Reply Like
  • Thanks, OG-


    On the bios that may work better than on the rest of the zoo where it seems sometimes that the pr is in reaction to the scuttlebutt on the street.
    9 Oct 2013, 09:17 PM Reply Like
  • Keryx +3% after Zerenex NDA filing accepted by FDA
    Keryx Biopharmaceuticals (KERX) +3.1% premarket after announcing its New Drug Application for Zerenex has been accepted for filing by the FDA.The NDA seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels in patients with chronic kidney disease on dialysis.Included in the NDA filing are safety and efficacy datasets derived from Phase 3 registration, as well as data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.
    8 Oct 2013, 11:13 AM Reply Like
  • This week is the breakdown that many have been looking for on new entry points for the bio's that we watch.


    NVAX, PCYC, VRTX, just pick almost any stock.


    Everything getting hit hard today. Biotech especially. Even the big names like FB, APPL, etc.
    8 Oct 2013, 02:13 PM Reply Like
  • Medical news?


    Poll: Voters prefer hemorrhoids over Congress



    Voters say they have a higher opinion of hemorrhoids than Congress, by 53% to 31%. More than seven in 10 voters say they view jury duty more favorably than Congress, which musters only 18% support in that comparison. Even toenail fungus rates 3 percentage points higher Congress.
    8 Oct 2013, 02:47 PM Reply Like
  • Too bad Preparation H can't cure what ails congress...
    8 Oct 2013, 07:07 PM Reply Like
  • Oh so right, OG!


    It will require a surgical approach with a realy big knife...
    8 Oct 2013, 11:53 PM Reply Like
  • Maybe a really big supply of Ultra suppositories?
    9 Oct 2013, 09:00 AM Reply Like
  • Here's one take FWIW on the 10 top drugs in biopharma's late-stage pipeline (note Vertex #5) and includes a nice update on each one on the list
    8 Oct 2013, 04:06 PM Reply Like
  • NVAX down over 6% at the moment.
    9 Oct 2013, 09:55 AM Reply Like
  • Mercy: I was figuring this latests news, and that which came before, would let those negative on the stock start shorting. Also, buyers of the last round might include a lot of hedge funds who would want to short as well.


    I've been watching a similar scenario with (CPST) for a long time. Their short behavior didn't start to clean up until after June of last year and even now when we rise to much the short increase again.


    You can see it here.



    Look how short interest has almost doubled since December.


    I'm sure a goodly portion of it is real shorters too.


    I'm starting to look for another add point - haven't decided yet. Normally pps will rise going into options expiration week and then drop again starting around a week after. Pattern has gotten shaky over the last few months though, due to the RSV stuff mostly I think, and just recently reappeared.


    9 Oct 2013, 10:32 AM Reply Like
  • Good perspective, thanks HTL. In addition generally -- I suspected the Yellen halo effect would be short lived -- although I expected it to last longer than 2 hours! As long as the political stalemate persists on the budget/debt ceiling I personally expect smaller spec stocks to be liquidated more aggressively in the interim.
    9 Oct 2013, 11:00 AM Reply Like
  • i agree with both MJ & HTL, it should be a good entry point soon tho.


    Many good stocks getting over beaten now.
    9 Oct 2013, 12:06 PM Reply Like
  • (NVAX): On the charts there's a rising trend line that might offer support at ~$2.75 today. We might be close enough - trend lines are not that precise. But volume on this 7.52% down move is still strong so there's still a good chance it'll move through it if we don't see consolidation begin with some lower volume and narrowing price spread.


    That would put next targets at an unfilled gap from 8/14-8/15 with a range of $2.55-$2.68. Support is often found, at least short-term, at the extremes of these gaps. If it closes the gap, which is also quite likely, then we need to see what it does then.


    But I would be ready to pull the trigger at any of these points *once_I_see* decent signs of reversal of the down trend.


    Any overshoot could give us a nice juicy $2.40 entry point, again on signs of reversal.


    9 Oct 2013, 01:00 PM Reply Like
  • Good stuff, Hard.


    In looking at the five year chart, four out of five times NVAX has dropped after/during October. If history rhymes, the charts suggest the first two weeks of November is a time to add.


    Since October 3, NVAX is down 13.1%.


    Emotions (greed) tell me to add today. But your work and the five year chart stifles such thinking.
    9 Oct 2013, 01:17 PM Reply Like
  • I think the rise in Nov. is in expectation of flu season, which has been a dud as far as generating any business over the last few years.


    Maybe we'll do better with the progress that's been made this time around.


    9 Oct 2013, 01:28 PM Reply Like
  • Therapeutic company MannKind Corporation (NasdaqGM:MNKD) reported on Friday the resubmission of a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes.
    14 Oct 2013, 06:37 AM Reply Like
  • Savient Pharmaceuticals files Chapter 11
    Savient Pharmaceuticals (SVNT) files voluntary Chapter 11 petitions.
    The company is pursuing a sale under Section 363, with "stalking horse" bidder Sloan Holdings set to acquire Savient's assets for about $55M.
    14 Oct 2013, 08:24 PM Reply Like
  • Novagen.(NVGN)...anyone following this? or believe in it ?

    15 Oct 2013, 08:01 AM Reply Like
  • Some serious pumping there. Popped from under $4 to over $6 this morning, presumably from this article.


    A comment there puts it well:


    "Another anonymous submission about speculation built on rumor and unsupported company statements.... Caveat emptor."


    My concern is that this is another cancer treatment "promise" that will never get delivered:


    "We firmly believe that we are on the verge of changing forever how we treat cancer. Not just any one form of cancer and not just with the goal of prolonging life be weeks or months."
    15 Oct 2013, 12:12 PM Reply Like
  • Reegeneron, Sanofi drug slashes "bad" cholesterol almost in half
    A drug developed by Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) cut levels of the "bad" LDL cholesterol by 47% in a Phase III trial of 103 patients. No major side effects were experienced.The treatment, called Alirocumab, is part of a new class of injectable cholesterol medicines that block a protein called PCSK9. Amgen (AMGN) and Pfizer (PFE) are among those developing such drugs, which could each generate sales of $3B or more.Regeneron and Sanofi hope to file for authorization of Alirocumab by late 2015 after the results of another 11 studies are released. (PR)
    16 Oct 2013, 05:01 AM Reply Like
  • Zerenex could be worth looking into

    16 Oct 2013, 01:01 PM Reply Like
  • Keryx Pharmaceuticals soars as analysts hike targets
    Today's strength in shares of Keryx Biopharmaceuticals (KERX +19.9%) looks to be attributable to some upbeat commentary out of Brean and Roth Capital.Roth's Joseph Pantginis has boosted his price target on the shares to $24 from $16 on Zerenex optimism.Meanwhile, Brean is out with a $20 target based on what the firm thinks is a $1B chronic kidney disease market opportunity.
    16 Oct 2013, 03:49 PM Reply Like
  • Oct 17 (Reuters) - Keryx Biopharmaceuticals Inc :
    * Ladenburg raises price target to $19 from $15; rating buy
    17 Oct 2013, 08:24 AM Reply Like
  • Dynavax could get interesting now, look at the charts where it dropped to $1


    Dynavax sets Phase 3 trial for it's Hep-C drug

    17 Oct 2013, 05:37 AM Reply Like


    Uplisting To Nasdaq Just The Start Of Advaxis' Turnaround
    17 Oct 2013, 08:04 AM Reply Like
  • There has been allot of buzz regarding Regeneron. (REGN)
    They have developed some amazing technologies and proceedures.
    17 Oct 2013, 11:57 AM Reply Like
  • Robt, I posted a clippet yesterday, but I just can't bring myself to buy a $300+ biotech. I found it a long time ago, and did I ever miss a run.


    I think we are following a few that have the same potential. NVAX, KERX, Dynavax, PCYC
    17 Oct 2013, 01:01 PM Reply Like
  • I'm with you on that score. At 32X earnings it's pricey alright. I have a long position in NVAX which is currently up a couple of percent. I think it will do well long term. TLON was bought out and I took a small loss on that but had taken profit several times on the stock so I shouldn't complain as net it was a profitable trading stock. Galena (GALE) is still slowly climbing and has doubled since it's spin off from RXII. RXII did a nasty reverse split but that was more than made up for by GALE. I'm still long both stocks. I have a hold on RXII and a tentative buy on GALE but be advised gale is trading in a range right now. I'm buying on dips below $2 even. Thanks for the links.
    17 Oct 2013, 06:19 PM Reply Like
  • Its back


    Bird Flu’s Return in China Seen Sped by New Year Chicken
    17 Oct 2013, 10:19 PM Reply Like
  • PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (NASDAQ: ADXS, ADXSW), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, today announced the full exercise of the over-allotment option granted to the underwriters to purchase an additional 862,500 shares of its common stock and warrants to purchase an additional 431,250 shares (15% of the shares and warrants sold in this offering), at a public offering price of $4.00 per share and $0.001 per warrant, respectively, in connection with its previously announced underwritten public offering of 5,750,000 shares of common stock, and warrants to purchase up to an aggregate of 2,875,000 shares of common stock, bringing the total gross proceeds from the offering to approximately $26,500,000, before deducting underwriting discounts and commissions and other offering expenses payable by Advaxis, Inc. The warrants have a per share exercise price of $5.00, 125% of the public offering price of the common stock, are exercisable immediately, and expire five years from the date of issuance.
    18 Oct 2013, 01:57 PM Reply Like
  • Hey Doc!


    Do you know anything about the Ventura County giant sea snail, otherwise known as the giant keyhole limpet? Apparently, it has something called Keyhole Limpet Hemocyanin (a "magic" molecule in the sea snail's blood), which acts as a vaccine conduit for many, many types of drugs.


    A small company, Stellar Biosciences, is developing a way to farm raise the snail, and I'm reading that each extracted gram can sell for $30,000 to as much as $900,000 per gram. The process is patented.


    I check into stockgumshoe, a great investigative site OG brought to my attention years ago, which looks into potential scam stocks. The bottom line from the below linked article is that Stellar Biosciences (SBOTF) is a "speculative" play. SBOTF has been off to the races lately, zooming from 70 cents in July, to close at $1.71 today.


    --they say they are “actively exploring multiple, current avenues of co-involvement with 7 of the 15 largest biopharma companies.”


    Also, in September, they raised $12M via a private placement offering.


    Here's the stockgumshoe link:

    18 Oct 2013, 03:57 PM Reply Like
  • That is quite interesting, but I have not heard of it before.


    Keyhole Limpet Hemocyanin:



    "The KLH protein is potently immunogenic yet safe in humans and is therefore highly prized as a vaccine carrier protein. The large and highly glycosylated KLH protein cannot be reproduced synthetically. It is available only as a purified biological product from the Keyhole Limpet Megathura crenulata."


    Worth a further look, if this company has a patent moat for cultivating the critters and extracting the molecule.
    18 Oct 2013, 04:15 PM Reply Like
  • Maya, Scribe: Greetings. Thanks for the link. I'm going to explore this right away. How goes the book?
    18 Oct 2013, 04:19 PM Reply Like
  • They seem to have a moat but it's difficult to ascertain exactly how wide it might be. Management team seems decent at first glance. Performance data is extremely thin so it's definitely very speculative. I'm going to open a position Monday morning to track it and build a data base on the stock.
    18 Oct 2013, 04:46 PM Reply Like
  • I am liking what I see so far about the sustainable aquaculture of M. crenulata and the IP around the purification technology.


    Here is a quick overview poster from the company website:



    That C diff application in your second link also looks very promising. Clostridium difficile is the bug that causes pseudomembranous colitis, a nasty side effect of using antibiotics that many people get, where the antibiotic that treats some other infection in the body kills off the normal gut bacterial flora, leading to a very unpleasant (and occasionally life-threatening) form of colitis with diarrhea.


    A good explanation on wikipedia:


    If a vaccine against C diff can be developed, then lots of people who cannot tolerate certain broad-spectrum antibiotics could use them safely again.
    18 Oct 2013, 05:07 PM Reply Like
  • Stellar Biotechnologies Immunotherapy Technology Demonstrates Protection Against Clostridium Difficile Infection in Preclinical Study


    Wow! $7B annually spent on a fast growing intestinal disease.



    --Clostridium difficile is a major and growing cause of mortality and morbidity in hospitalized patients. C. diff is a type of bacteria normally present in the intestine, but which can overgrow as a result of antibiotic use. It causes severe diarrhea and life-threatening intestinal conditions such as colitis. Incidence of C. diff is at a record high in the U.S. with more than 330,000 cases reported annually. Deaths related to C. diff increased 400% in recent years. The cost of C. diff related treatment in the U.S. and Europe is estimated at more than $7 billion annually.


    SBOTF) (TSX-V: KLH), announced today, further to its news releases of August 22, 2013 and September 10, 2013, the closing of its private placement raising total gross proceeds of US$12,000,000 (the “Private Placement”). The proceeds of the Private Placement will be used for product research, aquaculture and KLH production development, capital expenditures and working capital.


    “We are very gratified by the successful and strong closing of this offering. With a sound balance sheet, validation from industry investment, and continued support from Stellar’s major shareholders, we can execute our expansion plans with confidence,” said Frank Oakes, Stellar President and CEO. “Our team is eager to capitalize on the broadened recognition for Stellar’s immunotherapy research and KLH leadership, and turn each strategic initiative into long-term shareholder value.”


    In connection with the Private Placement, the Company issued a total of 11,428,570 units (the “Units”) for total gross proceeds of US$12,000,000, completed in two closings ($10 Million in gross proceeds announced September 10, 2013 (the “Initial Closing”) and an additional $2 Million in gross proceeds announced today (the “Final Closing”). The Private Placement included a brokered portion sold to institutional and accredited investors totaling US$5,000,000 (4,761,903 Units) (the "Brokered Offering") and a non-brokered portion totaling US$7,000,000 (6,666,667 Units) (the "Non-brokered Offering").


    The Non-Brokered Offering included a US$5,000,000 investment by Amaran Biotechnology, Inc., a privately-held Taiwan biotech company and biopharmaceuticals contract manufacturer.


    Each Unit, sold for US$1.05, comprises one share of Stellar’s common stock and one half of a share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder to purchase one additional share of Stellar’s common stock at a purchase price of US$1.35 for a period of three years from the issuance date of the Warrants.


    Newport Coast Securities, Inc., an SEC registered broker-dealer and FINRA member firm, served as exclusive placement agent on behalf of the Company for the Brokered Offering and received a commission totaling US$346,325 and 333,333 placement agent warrants (the “Agent Warrants”). Each Agent Warrant entitles the holder to purchase one additional share of Stellar’s common stock at a purchase price of US$1.05 for a period of three years from the issuance date of the Agent Warrants.


    Subject to additional requirements imposed by the US Securities Act requiring longer hold-periods on certain of the securities for resale by US subscribers in the US market and a lock-up agreement with certain holders of the securities, the securities issued in the Initial Closing (2,857,143 Brokered Offering Units, 6,666,667 Non-Brokered Offering Units, and 200,000 Agent Warrants) are subject to a hold period expiring January 10, 2014 and the securities issued in the Final Closing (1,904,760 Brokered Offering Units and 133,333 Agent Warrants) are subject to a hold period expiring January 21, 2014.


    The securities sold by Stellar in the private placement were not registered under the United States Securities Act of 1933, as amended (the "US Securities Act"), and were sold in reliance upon exemptions from the registration requirements of the US Securities Act. Therefore, such securities may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the US Securities Act and any applicable state securities laws. This press release does not constitute an offer to sell any securities or a solicitation of an offer to purchase any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.




    Suggestion: We should be tracking this puppy closely after Jan. 21, 2014. Typically, from what I have learned and suffered through (remember my losing $4800 in under an hour on Susta, that sugary substitute, while taking my mother to get a flu shot?) is that the touters have already accumulated their shares, and will likely dump them before the lockbox period expires. So this stock "could" get hammered twice, once from the touters, and then again after the lockbox period expires next year.
    21 Oct 2013, 01:36 PM Reply Like
  • >Maya-


    Thanks for the reminder of the lockbox and the touters. I must have put out of my mind the severe singing I got when I jumped on Crocs (croc) at the wrong time.


    21 Oct 2013, 02:37 PM Reply Like
  • Inovio gets a good write up here:

    22 Oct 2013, 07:30 AM Reply Like
  • Author’s reply » Oct. 24, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (VICL) today announced that a review of the company's progress toward clinical testing of its Vaxfectin®-formulated therapeutic vaccine against herpes simplex virus type 2 (HSV-2) will be presented at the 2ndInternational Conference and Exhibition on Cell & Gene Therapy, held in Orlando, Florida.


    Published results from preclinical therapeutic vaccine studies demonstrated significant reduction in recurrence of viral lesions and viral shedding in HSV-2 infected guinea pigs.
    This is likely the reason for the 9% pop yesterday...
    24 Oct 2013, 08:19 AM Reply Like
  • Zogenix, Inc. (Nasdaq: ZGNX): FDA Approves Zohydro
    Copyright 2013, Street Insider News Provided by Acquire Media Corporation


    Not surprised here, but the stock is not up as much as I thought.
    25 Oct 2013, 01:15 PM Reply Like
  • Stellar Biotech is the real deal. I have been pleasantly surprised that the Private Placement hasn't stopped the rise of this stock. It has been more volatile since the PP but the trend is still up. KLH shows tremendous promise in many vaccines against difficult to treat diseases. It makes the vaccine much more effective and it boost the human immune response. Keep your eyes on this one folks!
    28 Oct 2013, 01:12 AM Reply Like
  • the mkt got caught on the wrong side of this one. Now come the upgrades.


    Oct 28 (Reuters) - Zogenix Inc :
    * William Blair raises price target to $6 from $3; rating outperform
    For a summary of rating and price target changes on U.S. companies:
    Reuters Eikon users, click on
    28 Oct 2013, 07:24 AM Reply Like
  • I threw some (SBOTF) on the board @ $1.99. I had meant to get some on the board last week but was side tracked. I will start building my data base now and may generate a separate concentrator if the stock gets really busy. However for now this forum seems to be the perfect place to post events and refined data on the stock as long as FPA doesn't object.
    29 Oct 2013, 04:28 PM Reply Like
  • I haven't bought any, yet, Robert. I may put a 100 shares on my board tomorrow, but I still have to check out how many touters are touting Stellar. Also need to get in there and scrutinize the charts.
    29 Oct 2013, 04:59 PM Reply Like
  • Author’s reply » That's what it's for Robert... I am looking forward to your posts.
    29 Oct 2013, 05:14 PM Reply Like
  • >Robert-


    Thanks for your info on (SBOTF).
    Can you share your thesis on that?


    29 Oct 2013, 11:09 PM Reply Like
  • Very good news for Cempra:


    Orphan drug designation for their fusidic acid drug.


    Fusidic acid is a very old antibiotic available in most countries, but not the USA, as a standard treatment for strep and staph infections that may be resistant to more modern antibiotics. They are going for a relatively unique indication with the orphan status: prosthetic joint infections, that are very often from resistant organisms acquired in the hospital.


    On top of their potential blockbuster solithromycin, this will be a useful drug.


    This press release preceded their announcement of an "earnings miss" this evening. (How relevant are "earnings" in an R&D pharma company spending millions on research?) Might be a good opportunity to pick up more shares.
    29 Oct 2013, 06:29 PM Reply Like
  • Well, rather than a drop on the "earnings miss," (CEMP) hit an all time high this morning on the good news.


    Perhaps people are actually paying attention to the potential rather than the news.
    30 Oct 2013, 01:51 PM Reply Like
  • Doc: CEMP has one heck of a pipeline! But just like Stellar, the charts since May show CEMP's up 100% and up more than 50% since Sept. 17.


    I can see a little profit taking coming in the next couple of weeks. Definitely worth tracking.
    30 Oct 2013, 02:07 PM Reply Like
  • I suspect this AM was profit taking, based on the volume spike.


    I would not be surprised that some folks with inside knowledge loaded up over the last couple of days as it drifted down, expecting this pop on news. The FDA leaks like a sieve.
    30 Oct 2013, 02:14 PM Reply Like
  • Mankind MKND


    Co announced that the FDA has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.Copyright (C) 2010
    30 Oct 2013, 07:18 AM Reply Like
  • (NVAX) gets a pop from FBR *COVERAGE INITIATED: Novavax (NVAX) initiated by FBR Capital. Initial rating Outperform.
    — 5:53 AM ET 10/30/2013
    Up 5% at the moment.
    30 Oct 2013, 09:48 AM Reply Like
  • Mercy: I believe the outperform is a correct call, but the recent couple of initiations and ratings seem to me to be timed so the folks that provided capital in the recent round of financing can get out with some profits.


    Never know, can only guess, but every time the chart suggests it's moving towards where I think it wants to go, we get such news.


    Of additional (short) interests ;-))



    Look at the increases. The hedge funds apparently see these calls as opportunities provided by the grace of ... "analysts"?


    I like the etchnology, the new management seems to be progressing, ... But it's way too early, as I've learned the hard way with this stock. If it wasn't for judicious selling of covered calls off and on, I'd be way behind when the time-value is considered.


    30 Oct 2013, 10:15 AM Reply Like
  • As always -- excellent perspective HTL.
    30 Oct 2013, 10:18 AM Reply Like
  • FBR Capital initiates coverage on Novavax (NASDAQ: NVAX) with a Outperform. PT $11.00.
    Analyst William Tanner, Ph.D comments, "We view Novavax as one of the mos compelling small-cap vaccine plays in the biopharma sector by virtue of the vaccine for preventing RSV infection. If safe and effective, we believe the vaccine could have broad utility for preventing infection in pregnant women, neonates (by virtue of maternal vaccination), infants, and young children and the elderly. Most encouraging may be the elicitation of so-called "palivizumab-like" antibodies, given that palivizumab (marketed as Synagis) has been shown to be effective for preventing RSV infection in high-risk neonates. We view the company's pandemic vaccine development efforts as promising, but until stockpiling plans are better understood, we find it difficult to ascribe much value to the programs."
    30 Oct 2013, 11:08 AM Reply Like
  • $11 price target suits me :) I'll take it.
    30 Oct 2013, 11:09 AM Reply Like
  • LT,
    Thought you might find interesting the comments under the SA Market Currents entry on this analyst upgrade. It appears that the guy who upgraded (NVAX) at FBR today -- is the same guy who had given the same outperform rating and price target to NVAX ( some time ago while he was at Lazard


    In any case -- I took some profits off the table today on NVAX and added a bloc @ $6.60 of Affymetrix which develops and manufactures DNA chip technology. This is a spec stock which I am holding for the medium term. Affymetrix just reported today in after-hours Q3 EPS of $0.05 per diluted share, better than Capital IQ consensus estimates for $0.02, and higher than a loss of $0.03 per share reported a year ago.
    Revenue was $80.4 million, edging CIQ consensus of $78.9 million, but higher than revenues of $79.6 million reported in the prior year period. (Source Midnight Trader)


    Last trade in extended hours for (AFFX) was $6.83 for an increase of 3.5% since the close.


    30 Oct 2013, 04:40 PM Reply Like
  • thanks for the tip MJ, I have AFFX on my watch list.


    Can't figure out the high price that was put on NVAX....I'm gonna hold for the long haul for now. However, I do dislike unreasonable targets this early & IMO $11 is a bit early.
    30 Oct 2013, 09:49 PM Reply Like
  • >LT-


    "$11 price target suits me :) I'll take it."


    With much pleasure!


    30 Oct 2013, 10:31 PM Reply Like
  • >MJ-
    I am sending you a pm
    30 Oct 2013, 10:49 PM Reply Like
  • Thanks WT -- and I'll share with others that WT pointed out a recent analyst sell recommendation on (AFFX). In addition I'll add that Reuters current analyst counts gave this distribution:
    1 (BUY);
    5 (HOLD);
    So it is definitely a mixed bag, and as I said to WT -- I move quickly on spec stocks in either direction when warranted by my goals. As always DYODD.
    31 Oct 2013, 06:15 AM Reply Like
  • Update: just sold (AFFX) @7.20 at the open. This one is volatile enough that I think (hope) I can get back in on another run down. I still like its patents.
    31 Oct 2013, 09:38 AM Reply Like
  • >MJ-


    Thanks for the thinking on (AFFX).
    Think I may work an "X" and "O" chart on this hot number.


    31 Oct 2013, 02:12 PM Reply Like
  • Nice catch on (AFFX), MJ! That $7.20 was a perfect out.
    31 Oct 2013, 02:20 PM Reply Like
  • Thanks WT -- I needed that offset against the 4% drop in Telenor pps this am after earnings release!
    31 Oct 2013, 03:01 PM Reply Like
  • In the category of -- I wish I had known about this earlier -- SBOTF is up 941.88% since Dec 4, 2012. Even though it's just a couple of hundred bucks for a 100 shares, I can't get myself to pull the trigger before some kind of retrace occurs.


    Stellar is at the very top of the "parabolically" rising Bollinger Band, and even though on Yadoodle it states the 52 week high is $2.30 (which may have been and intraday fat finger trade), we're right at the resistance of $2.02.


    In discerning the 1 year chart, volume spikes "likely" were in conjunction with the touters selling off on Aug. 22 (1,619,600 shares) and then later on Sept. 18 (1,159,300 @ $2.00) and Sept 19 (1,198,500 shares) selling pressure drove the price down from $2.00 to $1.70 in two days of trading. Average daily volume is for the past three months is 389,549 shares. Since those three large daily volume spikes, another one has yet to occur.


    With company in town, I haven't had the chance yet to do some DD in relation to the timing of what touters like Wealth Daily wrote about Stellar, and those sell offs, but my SWAG leans toward these touting incidences being coincidental with the selloffs.


    I would love to see some Level 2 data. Wouldn't be surprised at all if another selloff occurs as just when the $2.00 mark hit before.


    But ya never know!


    Edit: There was another selloff of 946,700 on September 30. All four volume spikes occurred on days the stock dropped. Further evidence of the touters involvement....
    30 Oct 2013, 01:39 PM Reply Like
  • Re: further evidence of touters...
    Maybe 'bots?
    30 Oct 2013, 10:34 PM Reply Like
  • 4 more cases of MERS - 1 died

    1 Nov 2013, 06:04 AM Reply Like
  • pretty good read on ZGNX - IMO, this drug will still be a success but will take time and if they get close to a fix will be bought out. I'm NOT touting it or recommending to buy it now.


    Zogenix Pursues Development of Abuse Deterrent Formulations of Zohydro(TM) ER With Altus Formulation

    2 Nov 2013, 07:50 AM Reply Like
  • Merck Hepatitis C combo successful in Phase II trial
    A combination of Merck (MRK) oral drugs MK-5172 and MK-8742 led to high cure rates in a Phase II trial of 65 previously untreated patients with Hepatitis C.When given on their own, the combination had cured 100% of subjects after 12 weeks; when administered with the older drug ribavin, the success rate was 96%.Merck joins a list of other major pharmaceutical companies with Hepatitis C drugs that have shown high promise in trials, including Gilead (GILD) - whose Sofosbuvir appears to be close to receiving FDA approval - Bristol Myers Squibb (BMY) and AbbVie (ABBV). (PR)Meanwhile, Merck's V503 vaccine for human papillomavirus, a sexually transmitted virus that can cause cervical and other cancers, seems to have provided wider protection than the company's Gardasil shot in a Phase III trial .
    4 Nov 2013, 05:04 AM Reply Like


    One dose of HPV vaccine may prevent cervical cancer
    4 Nov 2013, 05:26 AM Reply Like
  • Zogenix, Inc. (Nasdaq: ZGNX) announced that it intends to offer and sell $60 million of shares of its common stock in an underwritten public offering. Zogenix also expects to grant to the underwriters for the offering a 30-day option to purchase additional shares of common stock, representing 15% of the offering amount, to cover over-allotments, if any.All of the shares to be sold in the offering are to be sold by Zogenix. Zogenix intends to use the net proceeds from the offering to fund pre-commercialization and commercialization activities for ZohydroTM ER, additional development activities of Zohydro ER and ReldayTM, and for working capital and other general corporate purposes. Zogenix may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses or products.
    4 Nov 2013, 07:14 AM Reply Like
  • PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (NASDAQ:ADXS), a leader in developing the next generation of cancer immunotherapies, announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer.
    5 Nov 2013, 08:30 AM Reply Like
  • looks to me like Merck has the best pipeline of big pharm.'s and I like this ADXS news too.


    Comments and your thoughts ?
    5 Nov 2013, 08:32 AM Reply Like
  • Keryx soars following more good news for Zerenex
    Keryx Biopharmaceuticals (KERX) jumps 15.6% premarket as Zerenex meets all primary and key secondary endpoints in a Phase 2 study.The trial tested Zerenex in non-dialysis dependent chronic kidney disease patients with elevated serum phosphorus and iron deficiency anemia.Mean changes in serum phosphorus: Baseline was 4.7 for placebo and 4.5 for Zerenex, EOT was 4.4 for placebo and 3.9 for Zerenex. Mean changes in TSAT: Baseline was 21 for placebo and 22 for Zerenex, EOT was 20 for placebo and 32 for Zerenex.KERX says it "plans to meet with the FDA to discuss these data with the goal of defining a path forward towards obtaining a labeled indication."
    5 Nov 2013, 08:36 AM Reply Like
  • Regeneron Pharma beats by $0.54, beats on revenues
    Regeneron Pharmaceuticals (REGN): Q3 EPS of $2.40 beats by $0.54.Revenue of $597M beats by $95.07M. (PR)
    5 Nov 2013, 08:36 AM Reply Like
  • SAN DIEGO, Nov. 5, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, announced today that it has priced an underwritten public offering of 26,666,667 shares of its common stock at a price to the public of $2.25 per share. Net proceeds, after underwriting discounts and commissions and estimated offering costs, are expected to be approximately $56 million.
    5 Nov 2013, 07:59 PM Reply Like
  • Kerex up $2.00 today on analyst upgrade to a price target of $26
    5 Nov 2013, 08:25 PM Reply Like
  • (NBY) Hammered by 50% for failing to meet desired endpoint on auriclosene.


    Down $.87 to $.82 @ 10:20


    "While the study showed that auriclosene is safe and well tolerated, it did not meet its primary clinical endpoint. NovaBay and its partner Galderma are examining the results from this study and expect to use the findings to guide the future course of the clinical development for auriclosene. NovaBay expects to provide an update in the near future."
    7 Nov 2013, 10:20 AM Reply Like
  • Re: (NBY)




    Did some digging on the company- seems auriclosene is their lead product. Everything else is secondary. Without significant results I feel it better to get out of it what you can now- I'm out on a bounce and licking my wounds.


    NBY has an earnings statement scheduled for pre-market tomorrow, 8 November.
    7 Nov 2013, 01:37 PM Reply Like
  • Yeah, that drop was painful today. I was in the green on NBY and it lost nearly half its value today.


    But I do not see this as such bad news as the market has. I frankly did not put much faith in auriclosene being useful topically for empetigo. Conventional oral antibiotics will get better tissue penetration and higher microbicidal levels than a topical disinfectant, which is essentially what auriclosene is.


    However, auriclosene's P2 findings for urinary catheter encrustation were quite robust when reported earlier this year, and I think that is potentially a bigger and more stable market than empetigo. Patients with longstanding indwelling catheters due to neurologic disease or injury will need this to reduce bladder infections and the need for more frequent catheter replacement, which could be a huge cost savings to patients and hospitals, as well.


    I am holding on, because I think auriclosene will turn out to be a very good anti-infective agent for other things than empetigo. Wound management, intra-operative cleanup and wound sterilization, diabetic ulcer treatment, urinary catheters, etc.
    7 Nov 2013, 05:30 PM Reply Like
  • Author’s reply » Totally agree with that assessment Doc... solving the urinary catheter encrustation problem is a big issue.
    7 Nov 2013, 05:42 PM Reply Like
  • Here are a couple of reviews of the issue of catheter encrustation and the current inadequacy of effective management approaches.




    Proteus mirabilis is the common bacteria that creates biofilms on catheters, and antibiotics do not penetrate that biofilm. The alkalinization of urine caused by P. mirabilis breaking down the urea in urine into ammonia causes calcium and other ions to precipitate as crystals on and in the biofilm, until it builds up enough to block flow in the catheter.


    Auriclosine will penetrate and kill the biofilm of bacteria, and it is completely non-toxic to the host tissues, so it has the potential to revolutionize indwelling catheter management.
    8 Nov 2013, 09:36 AM Reply Like
  • Is anyone aware of a biotech/pharma company that holds a patent or patents on altering synthetic tetracycline to create new antibiotics to
    combat superbugs that currently have no medications that work against them?
    It's an agora tease and I don't know the company. Thanks.
    7 Nov 2013, 12:54 PM Reply Like
  • Author’s reply » Trius Therapeutics acquired by Cubist Pharmaceuticals?
    7 Nov 2013, 01:21 PM Reply Like
  • OG -- only related one I know is (TTPH) Tetraphase Pharmaceuticals. Don't know much about them except they are very small but have good volume liquidity which is always my first check point before researching:
    7 Nov 2013, 01:27 PM Reply Like
  • Excellent guess, Mercy.



    I got there by searching for synthetic tetracycline pharmaceuticals:


    This sounds like it fits the description. Worth a closer look.
    7 Nov 2013, 05:04 PM Reply Like
  • Thank you! I came up with semi-synthetic tetracycline through
    Pharmacia & Upjohn Co, Division of Pfizer Inc and thought that can't be right...
    7 Nov 2013, 07:02 PM Reply Like
  • OG,


    Tetraphase just did a public offering of 4.5MM shares at $10 to fund their continuing trials of eravacycline. See the SEC filing:


    We have incurred annual net operating losses in every year since our inception. Our net loss was $21.6 million for the year ended December 31, 2011, $15.1 million for the year ended December 31, 2012 and $8.2 million for the six months ended June 30, 2013. As of June 30, 2013, we had a deficit accumulated during the development stage of $98.3 million. We have not generated any product revenues and have financed our operations primarily through the public offering and private placements of our equity securities, debt financings and revenue from U.S. government awards. We have not completed development of any product candidate and have devoted substantially all of our financial resources and efforts to research and development, including preclinical and clinical development. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. The net losses we incur may fluctuate significantly from quarter to quarter. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.
    We expect that our expenses will increase substantially as we continue our ongoing Phase 3 clinical trial of our lead product candidate, eravacycline, for the treatment of patients with complicated intra-abdominal infections, or cIAI, and commence our planned Phase 3 clinical trial of eravacycline for the treatment of patients with complicated urinary tract infections, or cUTI, seek marketing approval for eravacycline, pursue development of eravacycline for additional indications, including hospital-acquired bacterial pneumonias and other serious and life-threatening infections, advance our other product candidates and satisfy our obligations under our license agreement with Harvard University. If we obtain marketing approval of eravacycline, we also expect to incur significant sales, marketing, distribution and outsourced manufacturing expenses, as well as ongoing research and development expenses. Our expenses also will increase if and as we:


    • maintain, expand and protect our intellectual property portfolio;


    • in-license or acquire other products and technologies;


    • hire additional clinical, quality control and scientific personnel; and


    • add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
    Our ability to become and remain profitable depends on our ability to generate revenue. We do not expect to generate significant revenue unless and until we obtain marketing approval for, and commercialize, eravacycline, which will require us to be successful in a range of challenging activities, including:


    • commencing and successfully completing Phase 3 clinical trials of eravacycline;


    • applying for and obtaining marketing approval for eravacycline;


    • protecting and maintaining our rights to our intellectual property portfolio related to eravacycline;


    • contracting for the manufacture of commercial quantities of eravacycline; and


    • establishing sales, marketing and distribution capabilities to effectively market and sell eravacycline.


    So they are diluting to fund the P3 study of this novel tetracycline.


    I am still looking into the pharmacology of this drug, but here is a publication about the chemical synthesis:


    Here is a pub about the in vitro activity:


    Here is the FDA fast-track status:
    8 Nov 2013, 11:35 AM Reply Like
  • The current phase III trial for eravacycline complicated intra-abdominal infections is based on this P2 study:



    Results look good from this preliminary trial, and the pre-clinical posters I have examined do support the broad-spectrum activity against many resistant organisms.


    Including resistant strains of the clap:
    8 Nov 2013, 12:47 PM Reply Like
  • THANK YOU very much for the time you have taken to research and share this, Doctor.
    Did you see where their BARDA funding is uncertain? Is this just a nod to sequestration?
    While the FDA fast tracked it, that was in July. It's already baked into the equation, so to speak. It looks like there is nothing on the horizon until they announce positive results from P3 studies--studies that have not yet commenced.
    This one is on the back burner to watch, imo. I see no compelling reason to buy it now, if ever.
    8 Nov 2013, 01:48 PM Reply Like
  • I agree, OG.


    Very promising drug, if the P3 studies do not detect nasty side effects, but too soon for me to start buying without more innformation and study.
    8 Nov 2013, 04:19 PM Reply Like
  • 2 upgrades in 2 days into the $22-26 range. Either buy or beware!


    JPMorgan lifts target on Keryx Biopharmaceuticals


    JPMorgan reiterates Keryx Biopharmaceuticals (KERX -6.6%) at Overweight on the strength of the latest Zerenex data (non-dialysis dependent chronic kidney disease patients with elevated serum phosphorus and iron deficiency anemia).


    Here's analyst Cory Kasimov: "Based on the data and management's comments on the conference call, we are updating our model to
    1) include a higher WAC at launch and
    2) to include a NDD-CKD revenue model from an iron supplement perspective rather than a phosphate binder."Kasimov predicts approval (ESRD) next year.
    Price target raised to $22 from $14.
    7 Nov 2013, 08:05 PM Reply Like
  • The Street has a negative view on Keryx and Furenstein provides a good opposite, I have no idea which is correct. Caveat Emptor applies here.

    7 Nov 2013, 09:25 PM Reply Like
  • NVAX earnings was out today and the cc gave a positive outlook and financially the company is in better shape with cash.


    IMO, it appears that 2014-15 will be their year.
    7 Nov 2013, 09:27 PM Reply Like
  • Funny,I came away feeling a little blue after looking at NVAX's #'s. They did a big time dilution to raise cash. Their burn rate is increasing. No surprises, it's just that they can burn through this cash quite fast, imo.
    Here is my question and I hope you all will share your thoughts:
    Shouldn't the parters be ponying up with some $$?
    7 Nov 2013, 10:18 PM Reply Like
  • OG, I understand your side and I think why you were negative. It does have merit, below are the excerpts that I found to be positive and the one thing I was disappointed in was the timeline to market or FDA approval. (which you warned about some time back)
    It appears that 2014 is pretty much going to be all phase II trials. IMO, this is why they had to dilute and raise cash, With a possible speed up in the flu vaccine if there's an outbreak or good enough news in Qtr 1 '14.
    Also, so far the bad strains of flu have been contained, but just yesterday the first case of MERS was found in Spain.


    Summary of my positive views:
    1. $146 M in cash should carry them a year or longer
    2. Very fast enrollment in the H7N9 trial,
    3. 100% efficacy in animals
    4. Results due "later this quarter" ... positive news should be good
    5. 2014 revenue increase (won't offset expense,IMO) but should help with increased expenses bringing vaccines to mkt.
    6. As to partners, it was probably too early for them. I don't understand these partnerships...perhaps u can shed light on who their partners are and what/when they may become more involved.


    I look for them to kick in about a year from now (late '14 or even '15 phase III trial periods when data is more concrete & positive toward approval)
    One last thing from me, by looking at the timeline to mkt, and also the chart....I think HTL was/is right on the stock correcting down further...I look for an overall nasty correction in the indexes between now and end of qtr. 1, 2014....I hope NVAX suffers a nasty sell off because that's where I will finish my stake for the long haul.
    Then positive news should create a bottom and the stock should move on positive news. I don't hold a position in KERYX, and I think it's risk/reward is a double or lose it all.....IF, NVAX drops and cleans the chart up, IMO it has a 4:1 reward to the upside.


    These are the brief excerpts copied from the cc:


    in July we initiated a Phase I clinical trial of our H7N9 influenza vaccine. This is the virus that began circulating in China back in March of this year.


    Again, the trial was fully enrolled in under 10 days, and I want to remind you a couple of key facts about this vaccine: So from gene sequence, from the date of gene sequence to first subject in was 91 days. We showed in parallel, in an animal efficacy challenge model, we showed a 100% efficacy. We published those data in the journal Vaccine and the trial has been completed, the dosing and follow-up visits were on schedule and data is coming out this quarter and we will announce the results later on this quarter.


    these activities will drive substantial increases in revenue in 2014 versus 2013, because of the new activities in clinical trials.
    8 Nov 2013, 05:25 AM Reply Like
  • As to stock price and my position, I have held a decent starter position for some time.... I will add more in the $2.40's +/- and the stock has a chance to break below that to $1.75 +/- which is where I will load up for the long haul.


    I would appreciate HTL following this and giving input from time to time as I value his research and chart abilities more than anyone I know.
    8 Nov 2013, 05:35 AM Reply Like
  • LT: Next week is options expiration week again. Today's bump looks like the normal run up to ~Wed of that week.


    Without going to deep, I suspect a top between $0.305 and $3.10, max. There a descending trading channel (NVAX) is currently trading within and it's resistance ATM is ~$3.09. By Wed next is s/b $0.307/8 or so. Allowing a little overshoot $3.10 seems possible.


    After that is should start a leg down toward the descending support, currently around $2.67 and dropping ~$0.04/5 a week.


    If it breaks below support and confirms, there's potential support at a gap-up open extremes, $2.68-$2.55 and mid-gap demonstrated support ~$2.60.


    This is all short-term stuff - when I get time and the urge simultaneously, I'll try and take a longer look.


    8 Nov 2013, 04:56 PM Reply Like
  • Well, looks like this guesstimate missed by a wide margin!


    5 Jan, 05:13 PM Reply Like
  • lol HTL, something is going on behind closed doors that we don't know about.
    Otherwise to breakout above $5 and still climbing makes no sense. However, I'm still holding a fairly large position. Maybe it will make up for my AXPW loss, but I doubt it ! :)
    5 Jan, 05:25 PM Reply Like
  • Author’s reply » I suspect going over 5 changed the potential investor mix, so previous historical resistance levels may no longer apply… They also have a lot of cash, so fear of an offering should be diminished… so why sell?
    5 Jan, 06:10 PM Reply Like
  • Not as good as I would have liked, and the combo trial did not work.
    Maybe SMartin can contribute here as to approval.


    Advaxis Reports Final 18-Month Survival Data for ADXS-HPV in Patients with Recurrent Cervical Cancer at the 2013 Society for Immunotherapy of Cancer Annual Meeting
    --Final 18 Month Survival Data Has Increased to 28% from the 22% Previously Reported-- PRINCETON, N.J.--(BUSINESS WIRE)--November 08, 2013--
    8 Nov 2013, 09:11 AM Reply Like
  • Author’s reply » New Concentrator Link:
    9 Nov 2013, 08:46 AM Reply Like
Full index of posts »
Latest Followers


More »

Latest Comments

Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.