“The nature and timing of any post Provenge therapy for 9902b patients between ITT and placebo patients may have a substantial impact on survival statistics, especially in the case of sicker patients where quicker and more dramatic rescue is vital…
….the relative impact of follow-up therapies (Taxotere, other taxanes, CTLA-4 blockers, etc.) may have unpredictable impacts that extrapolation of statistical results from the 9901 and 9902a trials to projected 9902b results may not account for.”
Provenge, as you note, overcame crossovers in 9901/02a …are you suggesting that if there are no controls on the use of all the new combination therapies…9902b is then just a crap shoot? And while “unpredictable” –the impacts are more likely to be negative regarding any interim look? What about final analysis?
