I think my earlier suggestions on triple-blind analysis is still worthy of consideration at DNDN and the FDA. Even if FDA doesn't by it right away, they could publish papers and get people interested in working with them. <sarcasm> While I'm not sure this will work as good as threats against opposing oncologists, </sarcasm> if you had a blinded party that could analyse the data with prognostic factors and predict which were drug and placebo patients based on excess survival, that would eliminate all the questions about after-the-fact ad hoc rationalization. My wavelet technique would be one way to separate them once you have predictive model ( based on casuality as much as possible rather than fitting).
To reiterate another point, if they had an MOA and all the gene chip results from prior patients and had calibrated the results from pure cultures of things like DC's or NK's they wouldn't have to guess on endpoints. They would probably be able to tell confidence in PSA dynamics versus someother endpoint and impress everyone when they got stat sig on the chosen endpoint.