Monday, May 24, 2021 4:13:24 PM
For a life threatening disease, we had 81% efficacy with a certain dosage, and FDA decides to ask for new trials. What is the logic? Does not human lives matter that they keep changing goal post even after we have shown such results? Why would they not approve LL for that dosage and if needed ask that Cytodyn conduct new trials for the higher dosage as well, giving patients the option to enter such a trial? In fact the control for such a trial could have been combo LL with 350 mg; that has already been shown to surpass SOC from before, with 81% +-results.
If it was this straightforward as you put it, this does show FDA in bad light. Is this really the case? Shorts are always talking in black-and-white about trial success and failure; we succeeded in the trial and FDA's decision makes it appear like we never did, like LL is still an unproven drug.
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