An excellent summary of the issue of trial design and the support it provided, or otherwise to FDA approval.
However, the main reason stated by the FDA for why approval was not given, was the lack of adequate methods to demonstrate consistency between batches.
The support that Novartis can give should help tremendously to overcome this deficiency in future submissions.
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-366
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