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Friday, 01/01/2021 11:38:35 AM

Friday, January 01, 2021 11:38:35 AM

Post# of 44690
FDA is “not going to hold adverse events against anyone” – especially in cases where the treatment is administered to very sick patients who otherwise would not qualify for ongoing clinical trials, he emphasized. “You can never say never,” but “we understand that for many of these rare diseases,” patients are “close to death’s doorstep, and there will be adverse events.”

https://pink.pharmaintelligence.informa.com/PS124296/Expanded-Access-Data-Can-Support-Approval-Decisions-US-FDA-Says