Replies to post #44901 on Biotech Values

[palindromy]

I agree, the "bad placebo" has no case wrt DNDN. I was more curious actually then to see the science behind choice of placebo.

OTOH, Scher's letter certainly gives a lot of fodder for people in FDA to say that the general scientific community is not behind Provenge. That in any case was my impression from the very beginning. Add to the fact that DNDN couldnt even get their lead PI at the panel and I have not heard or seen anything to substantiate that Dr Small himself supports the approval of Provenge at this stage.

[lumpy9200]

One of my biggest pet peeves was DNDN not releasing the final three-year placebo arm breakdown for the 9901 or 9902A trials between the placebo crossovers and the placebo non-crossovers. In the Sept 2003 interim data release, for the patients who had either completed three years after randomization or had died, the median survival for the placebo crossovers was 23.9 months, and the placebo non-crossovers 19.3 months. Based on this information and the final 76% rate of crossovers in the placebo arm, I believe that the median survival difference may have widened for the final tally in October 2004, as the final median survival for the entire placebo arm was 21.4 months.

I just don't understand why these numbers were not part of DNDN's package. They are pretty convincing to me.

Walldiver, correct me if I'm wrong, but surely Drs. Puri, Goodman and Witten will be thinking the same thing you are when deciding on final approval (especially Puri, who must know more than most).

I simply cannot see how one person (Scher), who already voted no, can have further sway with the FDA. His opinion was already known.

Best regards,
Geoff