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Re: F1ash post# 245921

Saturday, 04/11/2020 6:17:11 PM

Saturday, April 11, 2020 6:17:11 PM

Post# of 462568
This is the easiest puzzle to solve.
The words "You will receive" Means that all of the trial participants will be given the high dose of 50 mg of MTD in the open label extension study. In the first blinded part of the study some would be on other doses or placebo. So this could not possibly pertain to the blinded study. Plus could not change dose in blinded study....because...well its blinded.
This does however support my earlier thesis that the blinded part would use low, medium and placebo. Then calculate the statistically valid signal without the risk of AE derailment. In the OLE use 50 mg high dose or MTD of each patient.
In other words void the null hypotheses in the blinded trial by showing effect beyond placebo then continue to OLE at MT dose for each patient to show full efficacy vs. SOC.
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