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Dynavax Technologies Corporation Message Board

  • pdelcamen pdelcamen Feb 18, 2013 10:11 AM Flag

    FDA Briefing Docs Conclusion

    1.7 Conclusion
    Hepatitis B remains a public health problem in adults in the United States. Current vaccines
    work well in the pediatric population but less well in adults, particularly in some subgroups at
    high risk for infection. Adherence to a 3-dose, 6-month schedule challenges many in some of the
    highest risk groups. The delayed time to achieve seroprotective levels of antibody leaves some
    persons without seroprotection and at unnecessarily prolonged risk for infection. Clinicians need
    another option to overcome these limitations.
    HEPLISAV stimulates a pathway in the innate immune system that is an element of the natural
    response to an infection. HEPLISAV, compared with Engerix-B, met the primary endpoint of
    noninferiority, induced significantly higher rates of seroprotection, induced high rates of
    seroprotection in populations hyporesponsive to currently available vaccines and in populations
    with good responses, and provided earlier seroprotection that could be beneficial to certain high
    risk persons in need of rapid protection. In addition, administration of HEPLISAV should
    increase adherence by virtue of its shorter 2-dose schedule over 1 month.
    The safety profile of HEPLISAV was similar to Engerix-B. With enhanced safety surveillance,
    there were similar rates of local and systemic post-injection reactions, AEs, SAEs, new onset
    autoimmune disease, exacerbation of pre-existing autoimmune disease, or induction of
    autoantibodies in HEPLISAV recipients and Engerix-B recipients.
    Based on these considerations, the approval of HEPLISAV would benefit adults 18 through
    70 years old who are at risk for HBV infection.

    Sentiment: Hold

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    • antidisestablishmentarianism8392 antidisestablishmentarianism8392 Feb 20, 2013 11:03 AM Flag

      "Based on these considerations, the approval of HEPLISAV would benefit adults 18 through
      70 years old who are at risk for HBV infection. "

      Sentiment: Strong Buy

    • the final score has already been decided

    • Read it again....................What's important to remember............

    • Once again..........what's important........just a reminder

    • The FDA's OWN WORDS, ......This could easily be mistaken for some Seeking Alpo article pumping a stock but it's not.

    • If the FDA were looking for a reason to sink Heplisav and Dynavax (before that stupid, kangaroo panel last November), they had plenty enough opportunities to do so. Only one of which was the result of the lot-to-lot trial which Dynavax conducted back 2 or so years ago.

      I'm sure that all of the longs here remember that event well, and the outcome of it.

      The FDA had the chance to nail the coffin shut there, but what did they choose do at that time?

      So now, because of this rogue creep, Daum, and his corrupt proceedings it's now time to throw away all of that previous work and side with him, simply because of the "racial makeup" during trials???
      That would be BEYOND throwing out the baby with the bathwater!
      I fail to believe that Maggie Hamburg and her people would have lost their sensibilities that much.

      Sentiment: Hold

    • "Clinicians need another option to overcome these limitations."

      "Clinicians need another option to overcome these limitations."

      "Clinicians need another option to overcome these limitations."

      One sentence, eight words; it sums up the FDA's view and approach to the problem (and I don't think I'm mistaken on what the FDA is indicating in that sentence).

      The FDA HAS BEEN WORKING WITH DYNAVAX ON THIS ISSUE SINCE 2008. To turn counter to their own efforts and pull the plug on Heplisav and Dynavax after all of their OWN efforts since 2008 would suggest a empty-headedness by the FDA which would be unparalleled during even the Bush years of goverence (when simply delaying most all drug approval applications was the FDA's plan for handling the vast number of drug companies seeking application for a product; and that wasn't much of a very good plan to say the least.

      It's all there, 1 sentence, eight words.

      Thanks for posting that conclusion statment, pdelcamen

      Sentiment: Hold

 
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