Biotech Values

[iwfal]

One doc asked if his patients are going to respond as in 9901, or as in 9902A because for the latter he wouldn't adjust his treatment strategy for patients.

Well, that would be irresponsible. From a clinical standpoint the 9902a provided as much benefit as Taxotere. With less side effects.

Yes, I am being a little flip - but there is this strong, and irresponsible, tendency to view any trial that didn't hit p as complete failure, or even more strongly proof of lack of efficacy. When in fact it is fair to say, as the FDA stats reviewer did - that all of the endpoints were on the right side of HR=1.0. The p value should come off the totality of the data. And so should the HR. The odds that Provenge is a dud are pretty low - certainly lower than the 1 in 20 that you and David are bantering about. Again, when asked to speculate what the HR of 9902b would be in a known sicker population you speculated it would be 1.23 (if I remember correctly).

Clark