DNDN had been downgraded 7 ways from Sunday for the last 2 years by numerous analysts… if not all, except David Miller and other newsletter folks.
Every time there is some sort of positive development, a reiteration of the downgrade comes out… why? (obviously I have my theories)
I just do not understand why these analysts will put their reputations on the line, by stating the Provenge will not get full approval when the decision is so close. (Mind you, many of these analysts never thought DNDN would even get as far as submitting a BLA for Provenge.)
Conditions for Provenge approval have become favorable, yet the analysts still take a blind eye to them. For instance:
1. Provenge targets a medically underserved segment of prostate cancer patients. The patient options are very limited.
2. Provenge increases survivability.
3. Very limited side effects. (chills and fever during the infusions… that is it.)
4. FDA/NCI sponsored events which, IMO, was a confession by the FDA that they need to reevaluate how they review cancer vaccines. Supporting the theory that decision makers will look beyond just the statistics.
So, there is absolutely NO safety risk with a drug that has shown to increase survivability to a population that is medically underserved… and the FDA will ask for MORE data, keeping the treatment from getting to these patients for another 2yrs or so? WHY?
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 SUE the fuck out of the FDA.
If I were the FDA, or the committee making the decision, I would allow the treatment to market while closely monitoring concurrent phase 4 studies in order to get a better view of efficacy. (FYI, this is what I think will happen.)
[...] 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. [...]
This almost has the smell of an FDA scandal….like some political heavy hand has put pressure on them or someone greased the FDA committee member(s) . There idea of sending the letter is a strategic delay connected to something. While this is all speculation its the FDA who opened that door. Remmember…perception is reality!
A former boss once told me ‘Perception is reality’, and my reply was ‘perception is the stupid man’s reality… i’m not stupid’. Since he didn’t want to be stupid either, he agreed with me
thanks for the comment