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CallMeCrazy

09/02/21 3:55 PM

#372968 RE: sunspotter #372934

You don't seem to understand the EUA process.

Suggest you look under what is considered by the FDA, to prove safety & efficacy for an EUA and you will find that clinical trial evidence is not mentioned. There are many ways, and they list them, to show efficacy and safety for an EUA besides clinical trial.

Are you confusing the EUA pathway with the full approval pathway?

Suggest you look at my past posts where I noted this difference or do your own legwork on the FDA website.

You guys at like a tag team.

Your links don't even prove your point, but I think you knew that.

Message in reply to:

"Can you prove there have been no EUA awards for trials under 121?"

Yes:

Vaccines:

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

Therapeutics:

https://www.fda.gov/media/136832/download

kfcyahoo

09/02/21 11:06 PM

#372996 RE: sunspotter #372934

""Can you prove there have been no EUA awards for trials under 121?""

A company recently announced results of a covid trial which reduced death rates vs soc by ~50%. I could not find the specific clinical trial referenced in the pr, perhaps I did not investigate enough, but it evidently included 52 severely compromised covid patients.

https://www.sec.gov/Archives/edgar/data/1175151/000110465921112116/tm2126800d1_ex99-2.htm