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Re: dennisdave post# 706392

Tuesday, 07/23/2024 4:05:11 PM

Tuesday, July 23, 2024 4:05:11 PM

Post# of 823592

Therefore short's claim that the FDA will always demand individual patient-level data for ECA comparison is idiotic dumb and stupid


The FDA guidance on this reads easy,

Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations,


Your argument that this makes no sense because it makes trials impossible is absurd as trials are being run with these constrains.
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