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HyGro

10/18/22 12:08 PM

#522822 RE: LearningEveryTrade #522750

Survival tail is not a trial endpoint. No P-value, post hoc data dredged rGBM. Not part of the original protocol, at best an exploratory data point, but certainly not for regulatory approval.

If you understood how the FDA operates -- it is regulations (law) or guidelines (FDA exercising their rule making power). No "rules."