We can whine all day about wanting an approval fro
Post# of 148167
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Posted On: 04/22/2021 12:24:59 PM
Re: Goosebumps #87497
Quote:
We can whine all day about wanting an approval from the FDA but they just look at us and say... if only you hit the 30% we would bend over backwards giving you the EUA.
Gee, I wonder why we didn't hit the 30%...
Quote:
The tapering of benefit may have occurred because patients were not given the drug for the final two weeks of the study per FDA guidance. What will overall survival be when critically ill patients are permitted to receive the full 4 weeks of dosing as originally proposed?
Seems they bent over backwards to ensure we didn't hit the 30%.
Go sell Leronlimab to the rest of the world. Let the FDA whistle for it.
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