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  4. CytoDyn Inc (CYDY) Message Board

Interesting CRL for MESO .. Assay mentioned .. Ma

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Post# of 155562
(Total Views: 477)
Posted On: 10/02/2020 9:35:17 AM
Posted By: reallypeople?
Interesting CRL for MESO .. Assay mentioned .. Maybe we got great info from FDA about occcupancy to avoid this issue


The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity. Assays measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk, such as SR-aGVHD and COVID-19


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