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Posted On: 10/24/2020 10:38:00 PM
Post# of 151866
Using the Fisher Exact test and p = .05, 21 patient mortality with leronlimab and 24 patient mortality in SOC gives a power of 87.2%.
Which would be more than sufficient for a BLA submission and the FDA standard of "must prove efficacy". But the standard for an EUA is "may prove beneficial" which is a much lower standard.
Which would be more than sufficient for a BLA submission and the FDA standard of "must prove efficacy". But the standard for an EUA is "may prove beneficial" which is a much lower standard.
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