They are partially correct, but very subjective in criticizing the FDA.
DNDN first hormone refractory prostate PIII trial had large pts population with Gleason score >8, so trial with sub-group analysis was too small for clear evidence of drug benefit.
<<This study contained a disproportionately high number of men with a Gleason score of 8 or above, which contributed to the results we saw with our interim analysis in January. After adjustment for these patients, the study yielded a significant therapeutic effect for Provenge.">>
Second, they have problem with vaccine manufacturing issue, and a second PIII trial was put on hold. This was cleared with FDA.
Third, they amendment second PIII protocol (this month), where pts only with score of <7 will be allowed.
So, FDA was not too harsh on them. Initial sloppy work in trial designee and issue on vaccine cellular composition was main factors to blame for delay, not FDA approach toward new drugs.
If they confirm results with second PIII trial FDA will be on their side, IMO.
Miljenko
PS: BTW, I am not sure that placebo as control arm is right choice here???
Happy and Prosperous New Year to all! |
