I agree yes its not really scientific to have a blanket rule. Wouldnt it be better to judge each study on it's own merits rather than a blanket rule? isnt that what the FDA's job is? I get that you cant have people making up secondaries post study and farming/fishing for significance but, you also can't just say "ignore cause of our rule" to pre sepcified secondaries that knock it out of the park like CHF and CLBP?
Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-122
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