Patrick, re DVAX: (Having trouble with Twitter, so resuming here.)
I agree with you 100% that there appears to be nothing in the ADCOM briefing docs that would suggest an upcoming FDA non-approval. However, the same was said about the ADCOM meeting itself with the resultant surprise.
IMO it was one of the worst calls since Roseanne was picked to sing the national anthem, but it happened, there it is. I realize that it’s just a non-binding recommendation but it puts the FDA in a pickle, and I think they’re going to wind up with a compromise "deal" on Heplisav approval: a restricted label and various post-marketing requirements.
That would certainly put a lid on the PPS, so I'm simply hoping for a bit of the usual pre-PDUFA run-up to to get out alive before the decision.
All that is needed to make a happy life is within yourself, in your way of thinking. -Marcus Aurelius
