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BioInvestor4

09/17/20 10:08 AM

#117419 RE: PSea #117417

Regarding EUA.... not exactly

There is no application or filing for EUA... there is an application for Diagnostics but not for drugs. The only application for a drug is for regular approval... CytoDyn submitted their reports to the FDA and asked for advise on EUA.... what NP was saying is they didn’t apply for regular approval as it would be rejected. They submitted the data for review and asked for advise on EUA