Don, thank you for that response. It raises some new areas of consideration for me, who is just learning the considerations behind trial design.
I did not quite realize how different the PIII trial is from the PII and how the design of the PIII trial really is based on deep interpetation of the PII results, as there is no direct comparison, as you point out.
It also underscores the explanations for the extended lengths of the PIII trials as the pt are stable. As such, it could take some time to identify any change in condition, placebo or rida treated.
I'm hoping Ariad did identify which pt it could help the most. It all illustrates the quite complicated trial design puzzle to determine what gives any drug the best chance for approval and for what purpose.
Stated endpoints notwithstanding, as DNDN Provenge was approved for what seems a quite modest improvement over no treatment, you'd have to believe Rida should have a reasonably good shot.