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Novavax, Inc. Message Board

birdyvax 272 posts  |  Last Activity: 8 hours ago Member since: Feb 4, 2013
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  • Reply to

    Order of things to come (imminent)

    by symptoms88 10 hours ago

    You couldn't have spelled it out any clearer. I'm in full agreement.

    4) TKM-E is proven effective in humans, saving lives.
    5) Stockpile orders come in and we hit $50+/Share.

  • birdyvax birdyvax 13 hours ago Flag

    Dave, I been following TKMR for a while thanks in part to your posts on NVAX...
    I jumped in a few weeks ago at $13.31 right before the FDA lifted the hold.
    I bought a little over 4k shares which is much for me...
    The Ebola news gets worse everyday and TKMR has the best treatment option available.
    Hope you're still in. Good luck either way...

  • birdyvax birdyvax 14 hours ago Flag

    'Not heard of the Dude..."

    LOL... Dude went into hiding today.
    The handwriting is on the wall... He just missed it.

    Over $20 today.

  • birdyvax birdyvax 15 hours ago Flag

    IBT not IBS... (My bad).

    From Medscape August 4/2014:
    "Another path to an Ebola vaccine would be to do studies in animals under the FDA’s Animal Rule, a “very long process,” says M. Javad Aman, PhD. He's a former research scientist at the U.S. Army Medical Research Institute of Infectious Diseases.

    The rule applies to drugs and biological products, such as vaccines, developed to treat or prevent serious or life-threatening conditions caused by exposure to toxic substances. Because it would be unethical to test such drugs or biological products by deliberately exposing people to a toxic substance, the Animal Rule allows the FDA to approve them based on how well they work in animals. The agency applied the Animal Rule in December 2012 to approve raxibacumab injection for treatment and prevention of inhaled anthrax.

    Aman is the co-founder of Integrated BioTherapeutics, or IBT, in Gaithersburg, MD. IBT has developed an Ebola vaccine that, like the vaccines against HPV (human papillomavirus), uses “virus-like particles,” or VLPs. VLPs are like a sheep in wolf’s clothing. They contain proteins found on the surface of a virus, evoking an immune response, but they lack viral genetic material, so they can’t make people sick. The IBT vaccine is intended to protect wild gorillas and chimpanzees, for which Ebola is now considered as big a threat as poaching and habitat loss, according to the company.

    In May, Aman and his collaborators published the results of a test of their Ebola vaccine in captive chimpanzees. The study found the vaccine triggered an immune response.

    While “it’s very promising,” the vaccine is not ready to be tested in people, Aman says, citing manufacturing challenges. “At this point, we’re also looking for funding. We would need additional support to take it to the next level.”

  • Located directly across the street from NVAX is Integrated Biotheraputics.
    IBS, named Maryland company of the year, has developed an Ebola vaccine using VLP Tech...
    IIBS has NO manufacturing capabilities, unlike NVAX who has bioreactors ready to go...
    Many new, 'open positions' have been added to the NVAX website...
    NVAX is seeking a Director, CMO Manufacturing. CONTRACT MANUFACTURING. Using NVAX's facilities to produce other companies products.
    Why all the new open positions all of a sudden at NVAX related to manufacturing?
    We know from the MTSL report that NVAX is fully funded for all its RSV programs but could also fund some 'new programs.' So what new programs were they alluding to?
    BARDA's job is to save us from pandemic threats... Ebola could soon reach pandemic status.
    So NVAX is called on to team up with IBS to make VLP Ebola vaccines and BARDA foots the bill.
    Yes... A stretch, but who knows?

  • birdyvax birdyvax Aug 20, 2014 5:08 PM Flag

    "That is why they have the DOD contract and TKMR does not."

    Then why did the DOD recently award TKMR an $140 million Ebola contract while discontinuing SRPT's Ebola contract?

    And why did the FDA lift the TKM-E hold for infected patients?

    And please explain why SRPT's treatment only saved 60-80% of primates while TKM-E saved 100%?

    So SRPT has a DOD contract for Marburg and TKMR has a DOD contract for Ebola... And Mapp can produce treatments that appear to work but have no manufacturing capabilities. I hope they all work to put out this Ebola wildfire...

  • birdyvax birdyvax Aug 20, 2014 4:03 PM Flag

    Steve, thanks too for the feedback and news updates...
    TKMR will climb on this news as the demand for an effective Ebola is growing as fast as the spread.
    Once TKM-E is proven effective at saving infected humans, the demand will be off the charts.

    As you posted...
    "Small Canadian Company to save the world
    Just watch.."

  • birdyvax birdyvax Aug 20, 2014 2:44 PM Flag

    Cont...
    Geisbert said the results suggest the drug has “real-world utility,” given that it worked days after the animals were infected and after the onset of symptoms. He added, “This approach has the potential for use against all filoviruses [such as Marburg and Ebola].”

    He added that further studies are needed to determine just how long after exposure to the virus the drug can be given and still be effective, and he said human trials are needed to ensure the drug’s safety.

    The findings come as governments and private companies have reignited efforts to speed up the development of medications and vaccines for virulent diseases amid the Ebola outbreak in West Africa. Last week, the World Health Organization said it would be ethical to offer unapproved treatments to Ebola victims, given the disease’s high mortality rate.

    Tekmira previously had begun “Phase I” human trials for an Ebola treatment but put those efforts on hold after the Food and Drug Administration raised questions about safety. However, the FDA has removed its “clinical hold,” potentially clearing the way for the use of the experimental drug in patients."

    Source: Washington Post

  • August 20 at 2:00 PM

    Researchers for the first time have effectively treated monkeys infected with the deadly Marburg virus, even when the treatment began days after the animals were exposed and had begun showing symptoms, according to a new study.

    The findings, published Wednesday in the journal Science Translational Medicine, could prove significant in part because the type of Marburg involved — the most lethal form — is closely related to the Ebola virus responsible for the devastating outbreak in West Africa.

    Thomas Geisbert, a primary author of the study and a professor at the University of Texas Medical Branch in Galveston, said the Ebola outbreak highlights the “clear and present danger” such viruses pose to human health and underscores the need for the development of effective countermeasures.

    There are no approved vaccines or drugs to treat the most deadly strain of Marburg — or Ebola, for that matter — and prior to Wednesday’s findings, no post-exposure treatment had been shown to entirely protect non-human primates.

    Geisbert said the study, which was funded by the U.S. government and conducted in collaboration with the drug’s manufacturer, Canadian firm Tekmira Pharmaceuticals, involved giving 21 rhesus monkeys lethal doses of the MARV-Angola virus.

    Sixteen of the monkeys received doses of Tekmira’s drug, which uses “small interfering RNA,” or siRNA, a technology that interferes with how the virus grows once it gets into a cell. Some of the monkeys were treated as soon as 30 minutes after being infected, while others received treatment beginning three days after exposure. All of them survived....

  • birdyvax birdyvax Aug 20, 2014 1:09 PM Flag

    I just read the article. It's very weak IMO. His main points are:
    - TKMR is riding too high on Ebola hype. He says this Ebola outbreak has been going on for 8 months.
    - Approved drugs are are years away.

    He does acknowledge the deep pipeline of TKMR in the 'comments'.
    He always acknowledges that he is short...

    What he is missing (or fails to admit):
    - Ebola is quickly turning into a Global problem... This is the worst Ebola outbreak in history. So far, there have been a lot of false alarms but pretty soon there will be confirmed cases outside of Africa.
    - The FDA has given the nod to TKMR to treat infected patients with TKM-E.
    - The WHO has allowed for the ethical use of experimental drugs citing Risk/Reward.
    - With ZMapp supplies exhhausted and no manufacturing capabilities, TKM-E is the only game in town.

  • 'Germany Ebola scare as Nigerian woman showing symptoms of killer disease faints in job center forcing 600 people into quarantine...

    Woman arrived at the job center with a high fever, then collapsed
    Hundreds of visitors and staff in the building were held
    The suspected Ebola victim has been taken to Berlin's Charite hospital
    By DAMIEN GAYLE FOR MAILONLINE and ALLAN HALL 19 August 2014

    'As many as 600 visitors and staff at the employment office building in Berlin were also stopped from leaving for several hours as emergency services sealed off part of the street.

    The mass-circulation daily Bild said the woman had fainted, that she hailed from Nigeria and that she said later that she had recently been in contact with people infected with Ebola.'

  • birdyvax birdyvax Aug 19, 2014 11:55 AM Flag

    This MTSL summary is worth reading again & again. It pretty much covers all the basis brilliantly...
    John M and the MTSL are the best in the bio-tech picking business.

    I wonder what 'new' programs they might be talking about?

    Thanks to vaxfil for posting and nvrfgtz for giving it more exposure.

  • Reply to

    Leerink Swann initiates with $25 Price Target

    by symptoms88 Aug 18, 2014 8:25 AM
    birdyvax birdyvax Aug 19, 2014 6:27 AM Flag

    "The company has significant opportunity beyond Ebola with its RNAi product and pipeline, according to the research report. These factors make Tekmira “uniquely positioned.”

    TKM-HBV, Tekmira’s hepatitis B drug has the potential to be a major growth catalyst says analyst Michael Schmidt. An investigational new drug application is expected to be filed in the second half of 2015.."
    Price Target: $25

    Source: Benzinga

  • Reply to

    Thank you Yahoo for the 'Ignore' button...

    by birdyvax Aug 18, 2014 6:43 PM
    birdyvax birdyvax Aug 18, 2014 7:14 PM Flag

    Agreed... There should be a way to block all, 'ALL CAPS' posts...

  • RIP all you desperate bashers.

  • Reply to

    PR For TKMR

    by cashcowrocketship Mar 25, 2014 7:24 PM
    birdyvax birdyvax Aug 18, 2014 10:06 AM Flag

    Prophetic statement back in March before the Ebola outbreak....
    "But all the same, Tekmira Pharmaceuticals Corporation (TKMR) is pushing ahead with its Ebola drug development and hopes that it will be a rewarding effort at the end of the day."

  • birdyvax birdyvax Aug 18, 2014 9:44 AM Flag

    FORBES: "Patients facing a deadly virus with no proven treatments deserve access to experimental drugs that have already established some basic proof of safety, and where there is plausible reason to believe that the drugs could provide some benefit."

    Tekmira was the second company mentioned after Mapp. The article stresses that we need to test these treatments now to see if they work.

    Say hello to $20+ any minute....

  • TKMR mentioned as effective in primates... Some serious but temporary side effects... $140 mill DoD contract... Phase 1...

    Could be a another big day for longs.

  • Reply to

    To paraphrase, "Houston, we have a problem"

    by knezevic67 Aug 17, 2014 2:55 PM
    birdyvax birdyvax Aug 17, 2014 4:13 PM Flag

    What you are saying is well within the realm of possibility. A week or so ago, Ben Carson (Fox) suggested that a terrorist could walk into the Emory hospital in Atlanta and bribe someone. He suggested a million dollars could buy Ebola infected urine. What he missed is that terrorists can get their hands on the Ebola virus very easily in Africa. Another thing they might to is infect people and fly them to America or the UK. Remember, symptoms can take up to 21 day...

    To those who have been following this closely, many Nigerians believe that Patrick Sawyer deliberately flew from Liberia into Nigeria, knowing he had Ebola in order to infect as many people as possible. So... this idea of using humans as WoMD is already on their minds.

    You would think that hospitals around the world would demand the most advanced Ebola treatments available even if they are still experimental. Last I heard ZMapp supplies are exhausted.

    This could be a huge week for TKMR

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