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Re: BioInvestor4 post# 117419

Thursday, 09/17/2020 4:46:59 PM

Thursday, September 17, 2020 4:46:59 PM

Post# of 236717
We seem a bit off. FDA website discusses Emergency Use Authorizations. These authorizations for Medical Countermeasures (MCMs) apply to drugs and other Biologics. The company can request an EUA from the FDA and the FDA has described a format and needed information to be submitted with the request. I do not know if there is some confusion over terminology re application vs request. But based on the FDA website there is a process to follow including asking for the designation and preparing supporting documentation.
As I listened to the call, I was confused by the cloudiness of the explanation given by NP. But my interpretation was that CytoDyn did not ask for the authorization.
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