No, I don't know that. That was a verbal comment made by SI in an interview and I doubt that's the complete substance of what the FDA might have said. A validated potency assay would be a prerequisite for an open label single arm trial but I don't think it would be the case for a blinded controlled clinical trial where the protocol was simultaneously testing the validity of any biomarkers associated with a proposed potency assay. So no, I don't know any such thing, and neither do you.
No, I don't know that. That was a verbal comment made by SI in...
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