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Posted On: 07/30/2024 12:53:08 PM
Post# of 151706
Honestly, given our incredible (unmatched?) safety profile re: a complete lack of SAE's -
and if just one of our studies shows efficacy - which several (AIDS, Severe/critical Covid) certainly have -
then the "correct" FDA response should be the greenest of green lights, grease the bureaucratic skids without delay and get this product to the patients.
It's stunning how many drugs (most all of them?) have so many significant SAE's, yet still get approved with barely any proof of efficacy.
To me, this is absolutely damning to the FDA and its process. If a product is safe, get out of the way and let it fly!
and if just one of our studies shows efficacy - which several (AIDS, Severe/critical Covid) certainly have -
then the "correct" FDA response should be the greenest of green lights, grease the bureaucratic skids without delay and get this product to the patients.
It's stunning how many drugs (most all of them?) have so many significant SAE's, yet still get approved with barely any proof of efficacy.
To me, this is absolutely damning to the FDA and its process. If a product is safe, get out of the way and let it fly!
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