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Re: thermo post# 544083

Tuesday, 12/06/2022 12:07:30 PM

Tuesday, December 06, 2022 12:07:30 PM

Post# of 703844
Very likely rGBM OS endpoint was defined before unblinding but it was certainly done AFTER the trial was complete -- a trial that was a NAIVE GBM trial. By tossing out the PFS primary endpoint, they were left with no other available endpoint so they had to gin one up -- they only had n=64 for rGBM OS which is inadequate for approval consideration. It was done after the trial was completed.
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