Biotech Values

[DewDiligence]

> But if I remember iwfal's comment correctly, even correcting for factors that were not well correlated to survival could reduce the "noise" in the trial and improve the P value. That sounds to me like you could always clean up the P value a bit by doing the Cox analysis (?)<

First, I think iwfal overstates the “noise cleanup” thesis, especially in a trial with as many as 500 patients. Second, picking achievable endpoints and analyses is as much a part of the negotiation process with the FDA as is setting the trial size, eligibility requirements, and so forth. Companies don’t get extra p-value for picking dumb endpoints, and they don’t forfeit p-value for picking smart ones.