Replies to post #953 on Dendreon Corp fka DNDNQ

[walldiver]

Dr. Bengt, it's possible, but not likely. I would also be very interested in seeing the four-year and/or the five-year data, but this data would only be academic, and probably unimportant to the BLA. I believe that the all-cause mortality data and the placebo crossover vs placebo non-crossover data would both be far more important to the FDA. If Provenge went up before the ODAC instead of the CTGTAC, it's more likely than not that the ODAC wouldn't even look at four or five-year survival data because it was not prespecified in the statistical analysis plan for either 9901 or 9902A. IMO, the stats wonks at the FDA would probably devote one paragraph or less to the four or five-yr survival data, which would be enough space to dismiss this data as post-hoc analysis and not statistically relevant.

Hopefully DNDN doesn't try to pull a fast one on the FDA by including that data. Including it would signal to the agency that the company is not confident in the quality of the Provenge BLA.

[Gametheory101]

I believe there were 12 participants in the 9901 trial who were still alive at the time of final editing of the JCO article. This would be over 4 1/2 years after the last patient was randomized in the trial.

While this data may not be significant to the FDA, it would be very significant to clinicians and patients. And hence to investors.