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Posted On: 07/22/2023 2:46:50 PM
Post# of 148870
Re: HouseofCards #135926
Quote:
The EUA only needs to show potential benefit, not proven benefit, compared to it's safety profile so it shouldn't matter if the trial was under powered.
The mild/moderate Covid trial did not have a positive p value in it's primary endpoint due to a badly written protocol. Who would have thought that allowing patients in with zero to few symptoms and having change in symptoms as the endpoint would be a bad thing.
Trials don't necessarily have to have a positive endpoint to go on to a phase 3 trial. Cytodyn chose not to go to phase 3 even though the flawed phase 2 showed promising results.
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The trial showed strong potential benefit in the severe to critical elderly population (ya know, the people who were dying the most) with a very low risk associated with the drug.
That was based on post hoc analysis which the FDA typically dismisses and was not part of the protocol. The lack of 4 doses was the breaking point.
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