The FDA has confirmed that it wants Dynavax (DVAX) to collect safety information from more...


The FDA has confirmed that it wants Dynavax (DVAX) to collect safety information from more patients for the company's Heplisav hepatitis B vaccine, although the agency also acknowledged an advisory committee's endorsement of the drug's "demonstrated immunogenicity." The extra information will facilitate a review for using Heplisav in adults aged 18-80. Dynavax's shares crater 26%. (PR)

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Comments (4)
  • THECHEMIST
    , contributor
    Comments (43) | Send Message
     
    It looks like someone at FDA has it in for Dynavax and is determined to make them look bad. I no longer trust any branch of this administration. It's all about politics and not science.
    10 Jun 2013, 09:03 AM Reply Like
  • Scrying Biotech
    , contributor
    Comments (2830) | Send Message
     
    No, it's all about tribalism and money. Dynavax isn't part of the governing alliance. Their product competes with those in the alliance and doesn't bridge the resistance by feeding into the ideological agenda of the administrative body.
    11 Jun 2013, 02:24 AM Reply Like
  • Rope a Dope
    , contributor
    Comments (708) | Send Message
     
    Chemist, I doubt you could find anyone more critical of this administration than I am, but I place no blame on them for the Heplisav developments.

     

    One of the best articles I have read on Heplisav was written just prior to the decision by the FDA Advisory Committee that the safety data was insufficient. The author, prior to the FDA decision, expressed concern that the FDA may have concerns about the Heplisav adjuvant and that is precisely the reason the safety of Heplisav received the negative vote. They didn’t say it was unsafe, they just said there was insufficient data to demonstrate safety. Here is a link to the article; http://seekingalpha.co...

     

    To me, the request for more safety information is old news and I’m shocked at the price drop this morning. I’m going to look at this further this morning as it may provide a good entry point if I am unable to find new derogatory news.
    10 Jun 2013, 09:55 AM Reply Like
  • Arthur Paullin
    , contributor
    Comments (502) | Send Message
     
    I think that people were hoping that (a) approval for one age group would be forthcoming and (b) that it would not take two years for additional testing.

     

    Without checking, I'm pretty sure there was not a huge drop when the news first came out about the decision an thus I think people were waiting for the results of the items noted above before bailing out.
    10 Jun 2013, 12:55 PM Reply Like
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