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C504

02/19/21 8:03 PM

#36234 RE: J-Belfort #36232

thanks
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Vanilla Fitbit

02/19/21 8:51 PM

#36235 RE: J-Belfort #36232

The don’t have to be on list...

to get approved, if I understand that correctly.

I believe some of the drugs that got EUA were not reviewed at those previous meetings..
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Clarnold

02/19/21 9:45 PM

#36236 RE: J-Belfort #36232

FDA 26th meeting:

The committee will meet in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.


https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement#event-information

However I don’t know if that’s the headliner and there are opening acts, so to say. There is also a meeting March 5 which seems much more likely we would be able to submit our information in time for. If you look at their submission process I don’t think we could make it by then. March 5 even seems soon.