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Posted On: 03/08/2021 3:18:42 PM
Post# of 145873
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I don’t believe the p value requirement for the trial is law, but rather implementing regulations. Laws don’t get to that level of granularity. When the President declared Covid a national emergency, he conferred to certain Cabinet Secretaries enhanced powers including the ability to get around regulations to fight the pandemic. The Secretary of HHS was specifically authorized. Therefore the FDA director based on delegated authority should have the ability to waive p value and grant EUA status to Leronlimab especially as Cytodyn is pursuing a new trial to increase numbers of patients and establish acceptable efficacy measures. I have emailed Nader of my belief.
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