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Dynavax Technologies Corporation Message Board

  • ctic_neutral ctic_neutral Jun 10, 2013 12:20 PM Flag

    Worlds most powerful vaccine bureaucrat, the prize clearly goes to:

    Dr. Robert Daum. A person of incredible power.

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    • Ctic - I could not agree with you more. What really worries me is that we now have a (ex?) GSK guy running the show. Could he be planted to bury our drug in more red tape and delays? What I really wonder as you said why didn't DVAX request the limited label vs. the full population? This sounds like the same mistake we made on the original BLA filing. Really really frustrated here.

    • CTIC
      Are suggesting that Daum and the FDA blind-sided DVAX ?

      Vette

      Sentiment: Hold

      • 2 Replies to vette1967jc
      • I'm just pointing out that he sunk the DVAX ship and we now see the FDA scurrying to the Daum position. Meaning Daum is probably the worlds most powerful vaccine bureaucrat, more able than any other individual to make or break a compound.

        'Cause we know if he'd been favorable we'd be in the money instead of dead as a doornail.

      • I don't know about Daum. His motivation is pure speculation. The FDA on the other hand clearly blind sided DVAX. If you recall DVAX was originally planning on filing for limited indication of 40 and over. A population that the available options do not adequately serve. When the FDA met with DVAX, someone at the FDA convinced management to go for the broader 18 and over group, a move that drastically changed the risk benefit calculations. Had the advisory panel been asked about limited approval for 40 and over I can easily see how the vote would have been positive. That decision has absolutely screwed this company and it appears the option to resubmit for a more limited group is now off the table.

        I'm very confused why the FDA would not look a CKD or an over 40 indication. There is clearly an unmet need and the efficacy is not in question. I was convinced that CKD would be a gimme.

        Wrong once again.

        Silver lining: The patent issues are going to be moot by the time this hits the US market.

        Here is hoping for Europe approval. If asked, I would vote against a buy out for anything less than $5 per share.

        Still long

 
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