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Re: HyGro post# 544609

Tuesday, 12/06/2022 1:11:14 PM

Tuesday, December 06, 2022 1:11:14 PM

Post# of 704240

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


You are correct. The protocol change was submitted in 9/2022. The trial completion data is unknown but would have to be well before data lock and if NWBO is to be believed was prior to 6/2022.

The more important point is that despite being blinded, they knew the results of the IA (as a fact) and other analysis (as an opinion, but I would be very certain). And changing endpoints after one knows the original failed is a huge issue.
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