“This is what most other drugs that has gotten E
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Posted On: 03/05/2021 11:02:55 PM
“This is what most other drugs that has gotten EUA starting with remdesivir has done.”
IMO, EUA is not possible at this time with the U.S. FDA. The FDA has communicated with CYDY in regards to EUA (CYDY told us they’d release data after discussions concluded) and per today’s PR, CYDY is submitting another protocol for the critical population. An additional protocol would not be needed if EUA right now was a possibility.
“Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions.”
IMO, EUA is not possible at this time with the U.S. FDA. The FDA has communicated with CYDY in regards to EUA (CYDY told us they’d release data after discussions concluded) and per today’s PR, CYDY is submitting another protocol for the critical population. An additional protocol would not be needed if EUA right now was a possibility.
“Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions.”
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