Umibe, thanks for the clarification. Your concerns are more clear to me now and they are valid. However, while I am also concerned that the PFS endpoint might not be met because of the possibility that adjudication of the psPD cases has been found to be very challenging, I believe that with respect to OS, statistically significant separation between trial and placebo will be obvious at least after the 36 months on trial period.
Furthermore, the amount of time available for attack on the PPS may be limited because with stellar results, the time between top line results and approval by the 4 RA's may not be that long. I am guessing that the first RA's approval will probably blunt any downward trend of the SP even if that approval does not originate at the FDA.
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