But how can you guarantee that the next batch from a different donor will be 70% effective? That is the question that FDA want answered.
How do you stop backyard clinics from offering MSCs to parents who are desperate for hope? This is the really big question.
Yes the expert panel have seen the effects of the product from one donor. What happens when they need a new donor? That is the question that FDA want answered.
Ann: DSMB Analysis Recommends to Continue P3 COVID-19 ARDS Trial, page-273
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