2 biggest fails with the current FDA: 1. Double
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1. Double standard for approvals, big company drugs vs small company drugs.
2. Completely untethered from their mission. This federal bureaucracy is supposed to help ensure unsafe drugs/medications don't hurt sick Americans. Enter Leronlimab, a drug that, by EVERY indication for the last 7 years, has hurt no one. And LL sits on the shelf while people suffer and die. Even if the P3 trials aren't yet complete, it should not be a stretch to give the Dr/patient the ability to request such a promising drug as LL if death is near. Bureaucrats are supposed to serve us, not vice versa.
In summary, if the FDA actually cared about the health of Americans, LL would have had an EUA for covid and off-label approval for whatever other indication for which it showed promise.
End of rant. For now.