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moneyman1010

11/16/12 12:02 PM

#152547 RE: biomaven0 #152546

Thanks for ur thoughts
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JJM760

11/16/12 12:11 PM

#152548 RE: biomaven0 #152546

Peter

Couple of things:

-allegedly the panel chair is a GSK consultant and was the only no on efficacy
- I believe some panel members asked for a 10k patient trial
- I also read on twitter that The CBER recommended a post approval study

I hate to be the conspiracy theorist, but I thought they got hosed. is it still possible to listen to the panel? If you have time, could you? You will prob need a few toothpicks to keep your eyes open.
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DewDiligence

11/16/12 12:48 PM

#152553 RE: biomaven0 #152546

I would say the DVAX panel outcome was due more to a sticky product stain than to sabotage. Even events that are several years old can subconsciously affect panelists, and Heplisav has had more than its share of staining events—including an FDA clinical hold and MRK’s dumping the product—during the past four years. Moreover, DVAX hasn’t always played straight with investors (e.g. #msg-34334331).