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sunspotter

09/23/21 12:24 PM

#375530 RE: Snowy_Owl #375523

“Do you believe the FDA approved compassionate use without any idea whether B works or not? “

They certainly approved this without any idea of the Phase II results.

They approve 65% of such requests.

zandant

09/23/21 12:52 PM

#375534 RE: Snowy_Owl #375523

Hopefully better than "not very well."

Minnesinger

09/23/21 2:37 PM

#375569 RE: Snowy_Owl #375523

Purely speculating, but I suspect it's a question of...

safety, rather than efficacy.

Do you believe the FDA approved compassionate use without any idea whether B works or not?



The FDA likely felt there was sufficient safety data - based on the current trial's interim, as well as previous trials - to grant the request. 'First do no harm' extends to the FDA, too. I would resist the temptation to view it as an acknowledgement of efficacy. The trial data is still blinded and in vitro outcomes aren't nearly enough.

To continue my speculation, I'm guessing that persons with a relationship to the company (shareholders, or other arm's length parties) had a friend/family member stricken with Covid and appealed to the company.