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Dynavax Technologies Corporation Message Board

  • joeyzazza01 joeyzazza01 Mar 4, 2013 7:17 PM Flag

    What DVAX should do....forget the FDA, focus on Europe

    You wanna play politics? Play politics, DVAX should just focus on getting European approval and let the U.S. become the laughingstock when better drugs are available in Europe due to FDA incompetency.

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    • Sure, I know who the 8000lb gorilla is in Europe Raven! Dynavax's eventual offshore partner, thats who!


      • 1 Reply to koufax62
      • Koufax,
        GSK IS, repeat IS already Dynavax's partner on 4 different programs; Heplisav just isn't one of those 4 though (yet).
        In short, I think that you are correct, and that is also my point. GSK rules the road over in the EU as well, so the road to the finish line (kind of sort of) has to go through the US FDA.
        Dynavax would not be better off trying a flanking manuever around the FDA and to the EMEA. Because GSK guards the door there as well.
        Win at home first and I would say that they recognition by the FDA would curry favor with the EMEA for "the nod" in Europe. I wouldn't necessarily say that it's a guaranteed shot doing it the other way around; there is not that much of a record of American companies doing it as EMEA first and then FDA anyways.
        The road for Heplisav goes through the FDA first or not at all (partnered or otherwise).

        Sentiment: Hold

    • And you don't know who the 8000lb gorilla is over in Europe?
      If they have the US FDA in their pockets (via a guy like Dr. Daum) wouldn't you suppose that there is a "mirror-counterpart" for the EMEA? I mean, if they are the "darlings" of the FDA, how could they NOT be moreso to their own home-turf agency?
      Just for laughs, go and search for Glaxo Smith Kline Worldwide Headquarters and see what answer it returns. It's kind of frightening (the reach of some companies in this modern age); now isn't it?

      Midnight Oil wrote in their song "The Dead Heart":

      ......Mining companies, pastoral companies
      Uranium companies
      Collected companies
      Got more right than people
      Got more say than people......

      Sentiment: Hold

    • Why? I think the potential for positive news (relative to discounted stock price/sentiment) out of the FDA meeting is very possible.

      The EMEA outlook is in fact very good, but by no means should anyone throw in towel yet where the FDA is concerned.

      To date not what the longer term stockholders were hoping for, but the company's fortunes can easily rebound in a big way from here IMO.


      • 1 Reply to koufax62
      • Yes, of course this is possible. But the FDA wants to play games, DVAX should as well; how do you issue a CRL to a company when THEY HAVE ALL THE DATA THEY NEED. They could have at a minimum approved it for high risk groups; instead, they put additional human beings at the risk of getting Hep B, and some will get Hep B when Heplsisav could have prevented it; for some people Energix does not work (Diabetes & CKD)

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