Replies to post #35200 on Biotech Values

[walldiver]

Thanks for the reply. Obviously, the p value in 9902A as a stand-alone measurement is not supportive, but IMO the hazard ratio, the 3.3-month median survival advantage, and the ~50% three-year survival advantage are. The p value of 0.33 could be construed as the result of what can go wrong in a small trial despite demonstrated efficacy.

Taken together with the fact that this trial was halted in mid-stream by the FDA and a few months later halted permanently by DNDN, I'm thinking that CBER will not look at 9902A as a negative. I'm definitely more confident of this view after getting a preview of the probable future advisory panel's impression of Provenge from the Feb 06 CTGT Advisory Committee minutes.