I told many about DNDN around $4-5 per share just before the Briefing Documents were published, and the AC meeting. Now many are asking, is it over? Well, the answer has become a complex one. The comlexity does not come from whether or not the science works, the complexity comes from the cowardice and politics of the FDA.
The hard part for Provenge should have ended with the AC meeting. The AC meeting removed virtually all uncertainty concerning the efficacy of the treatment. A 13-4 vote toward substancial evidence of efficacy is a pretty overwhelmig support of efficacy. This vote also gives the FDA justification to the nay-sayers concerning efficacy. For example, anytime someone questions their decision, all the FDA has to do is refer to the efficacy vote of the prestigeous panel.
But obviously the FDA did not do this. They decided to take a position which merits a huge amount of explaining, and will lead to a huge amount of scrutiny. Quite frankly, I am surprised this was allowed to occur, but I always thought it to be a risk, albeit after the AC meeting a very minimal risk.
In my Seeking Alpha write up “Will Provenge Get Approved?” I stated:
“If I were one of these medically underserved patients, and the FDA prevented me from taking this extremely safe treatment because they were uncomfortable with the statistics of the efficacy aspect of the treatment I would be very very angry at the FDA.”
Key words here are, ‘I would be very very angry at the FDA’. My orignal sentiment for those words were, ‘I would sue the fuck out of the FDA’. (see here) Well ladies and gents, the FDA is going to get the shit sued out of them, especially with the AC efficacy vote in hand.
I do not know if anyone has been paying attention to the blog-of-sphere and the media in general, many are angry. Many have already written to their Senators, Congressmen, Journalists, news agencies and the FDA itself expressing their concern, confusion and anger. This is why I am hard pressed to understand the FDA right now. Their actions toward Provenge almost welcomes a congressional investigation and scrutiny.
I never thought the FDA would want so much political pressure toward such a safe treatment (especially when they have gotten pressure on labeling for relatively unsafe drugs to market) so I always thought the risk against Provenge approval was minimal, especially after the AC efficacy vote.
So, is it over? I do not think so. But there is still uncertainty as to when Provenge will go to market. When observing the hiring trends, the company is obviously not as optamistic as they were after the AC meeting. We are literally held hostage by the ambiguity and internal political differences of the FDA. And if DNDN has to wait until 2010, then I think they will partner by year end. Also, on a valuation basis DNDN should be 8-10, with a partner maybe 15. But the FDA robbed the full potential of what DNDN could have been. (More importantly, the FDA robbed the hope of the PC patients with no other options.)
And as a last note… when the pressure on the FDA starts, those involved delaying Provenge should understand that their ousting from the FDA has started. (I hold them personally responsible for the early deaths of the PC patients that could have taken Provenge this year.)
ALOHA_GEORG> This is why I am hard pressed to understand the FDA right now
Understand what? FDA has not bothered to explain their decision not provide what is required to pass from “approvable” to “approve”
Why is an acceptable modus vivendi, that allows FDA to get away with major, life-death decisions without providing clear justification and a clear list of requirements.
Why are we accepting, that these FDA employees hide this stuff from their employers -taxpayers ?
You seem to think that the FDA is realy independant. I believe they are controlled by money just like everything else. There was too much money bet against DNDN. When billions of dollars are bet against something you can bet that those that made the bet willl figure out a way to not lose. I would love to see an investigation into the Doctors that came out against the drug and find out who they were really working for. Now that the massive short interest has been dealt with the company has a better chance of making it now. When these short selling hedge funds get trapped into a position they will do whatever they need to do to not lose money. I believe this includes paying folks and destroying companies. Just the way I see it.