Dynavax Technologies Corp (DVAX)

[oldberkeley]

LTG: The ADCOM results have been posted here and many other places since November, but thanks anyway.

It's unclear what you mean by "what have they done?" They've been in talks with the FDA, but the data are the data, no additional submission between the ADCOM and the PDUFA date.

What you seem to be driving at (OT: IMHO it's always clearer to simply state your position) is a belief that the FDA will not approve HEPLISAV. You very well may be correct.

This has been widely discussed on many sites, on many forums, in many blogs and articles: some say yes, some no. The bull & bear arguments can be found in an hour or so of careful reading.

FWIW, I somewhat agree with you, but perhaps for different reasons. The safety data are more than adequate, but I can't see the FDA totally going against their own advisory committee. Because of that, I'm expecting a compromise: a restricted label with post-marketing studies. Approved for use by high-risk groups: intravenous drug users, diabetics, those over 60, those traveling to areas where Heb B is endemic, etc.

Don't even get me started about the PPS after each potential scenario! It's a very dicey situation, again IMHO not a good risk/reward trade, and if I wasn't holding a sizable underwater position I'd most definitely stay away, there are safer bets.

Best of luck in all your trades. -OB