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CytoDyn Inc CYDY
(Total Views: 584)
Posted On: 01/01/2021 11:06:17 PM
Post# of 153925
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Posted By: ClosetInvestor
“Hopefully we get an approval that day also.”

I would taper your expectations in terms of the timing of an EUA following release of the S/C data. Approval will not happen the same day, or the same week, but could happen within a month or two.

REGN released the data on REGN-COV2 on September 29th, 2020, and the field for EUA on October 7th, 2020. The EUA approved the EUA on November 21st, 2020. So from flash to bang, the process took about 7-8 weeks. Now, CYDY investors will argue that given the current death rate per day, hospitalization rate, etc., that the FDA will expedite the EUA process if leronlimab reduces mortality. If the FDA does in fact do that, then an EUA could be possible within a month.

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