I see this all the time, most people that see the headlines FDA right away think it is actually the FDA, in this case it is NOT actually the FDA, it's an FDA Advisory panel, the actual FDA makes the final decision for DVAX on Feb 24th , 2013. The actual FDA does not always agree with the FDA panel.
This is not the best news for DVAX, but so far it is not the final news. That will come on FEb 24th 2013.
I will say, this might be an indication as to why the FDA did not give DVAX a priority review?
But remember.....they did give EXEL a priority review........and did not need the services of an FDA panel.
"I will say, this might be an indication as to why the FDA did not give DVAX a priority review?"
Heplisav did not get a priority review because it was not filling an unmet need. Although it represents an improvement on an existing therapy, there are already effective Hep B vaccines on the market. The rationale for Cabo is that although Caprelsa is already available, Cabo may be an improvement and there is good reason to believe that Cabo will also benefit patients refractory to Caprelsa. You also need to keep in mind that the Oncology Division has a great deal of latitude within the agency and does not always make decisions that are consistent with the other divisions.
The DVAX situation is very interesting and I am inclined to act on it this morning. Essentially the advisory committee did not behave in a manner consistent with prior decisions on comparable drugs. They are asking for a safety population in excess of that normally required. The tenuous safety signal seen in the clinical trial experience is something that would normally be handled by means of post approval studies in which a much larger n can determine if there is statistical relevance. The 8-5 split vote may give the FDA enough cover to overrule the committee and justify it with an ironclad postmarketing study. Worst case would be a phase 3 safety study without another trip through the adcomm. Downside would be dilution or partnering away a share of the drug to pay for extra study and delay.
Thanks ernie for making the points that you did. I am in the same camp as you are as far as DVAX, I'm considering buying here, I was noticing the 52 week high on the stock was over $5, not much but still there. I was noticing that it was only above $5 for a few very short time blips, the reason I consider that is because of the margin situation, above $5 the stock could have been bought on margin and if they are still in the stock they would definitely get a margin call with today's action. But with today's volume that must be a moot point now. So there will be no margin call pressure left in the stock. It looks like something to buy and hold until whatever needs be done gets done to me. One other consideration though right now is this is tax-loss selling season, with this kind of a hit in the stock there possibly could be tax-loss selling as the year winds down, but then again, with the massive volume today there probably is not be much of that left either. Looks like I'm going for it before the end of the day. Also , the action in EXEL does not worry me. Thanks again for the points you made.