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Re: rwwine post# 2151

Tuesday, 10/12/2021 12:59:29 PM

Tuesday, October 12, 2021 12:59:29 PM

Post# of 7836

…now my SWAG is after the FDA is more/less done with COVID-19 related vaccines and antiviral drug candidates.

I don’t think that’s a valid inference; most of the FDA’s COVID-related work is being conducted by the CBER Division, while the Daxi BLA review is being conducted by CDER Division.

In #msg-165929023, I said:

...the FDA group assigned to RVNC’s on-site inspection is the group that handles inspections for COVID drugs and vaccines.

The above statement refers to the FDA’s site inspections specifically—not to BLA reviews per se.

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