Rem Approval 2 Days After DSMC (is talking w/FDA??
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Posted On: 10/25/2020 2:56:32 PM
Rem Approval 2 Days After DSMC (is talking w/FDA???) gives Interim analysis recommendations to Cytodyn????
Below is a "hypothetical discussion, not real, a "parady" (a word Schiff likes).
DSMC: "you know Mr Hahn (FDA boss man), we are not supposed to be discussing these Interim results with you"
Mr Hahn: "as long as you don't show us the data, nor tell us specific data numbers, it's probably ok if you make some general comments to us, don't you think?"
DSMC: "well, I suppose we can tell you that we are deliberating between
a) stopping this leronlimab Phase III s/c critical due to compelling P value & power and recommending Cytodyn apply for FDA approval. We can justify this with the current p value, but the p value would be improved if there were more patients and if the death ratio placebo to leronlimab remained the same.
b) recommending the trial continue to 390 enrollment, but that would delay approval too long in our opinion, and the pandemic virus is winning, new cases are rising at alarming rates"
Mr Hahn: (knowing he, the FDA, was about to give FDA Full unrestricted approval to remdesivir the next day), "well, since you are not strongly favoring either of those choices, you probably would be safer to go with recommending continuing to 390, leronlimab is a very small, under financed company that has never produced any revenue, Primary Endpoint did not achieve Statistical Significance in their Phase II m/m trials, and approval now may just be risky, let's not rush this". Maybe you could take another interim look at a reduced number before they reach 390?"
Below is a "hypothetical discussion, not real, a "parady" (a word Schiff likes).
DSMC: "you know Mr Hahn (FDA boss man), we are not supposed to be discussing these Interim results with you"
Mr Hahn: "as long as you don't show us the data, nor tell us specific data numbers, it's probably ok if you make some general comments to us, don't you think?"
DSMC: "well, I suppose we can tell you that we are deliberating between
a) stopping this leronlimab Phase III s/c critical due to compelling P value & power and recommending Cytodyn apply for FDA approval. We can justify this with the current p value, but the p value would be improved if there were more patients and if the death ratio placebo to leronlimab remained the same.
b) recommending the trial continue to 390 enrollment, but that would delay approval too long in our opinion, and the pandemic virus is winning, new cases are rising at alarming rates"
Mr Hahn: (knowing he, the FDA, was about to give FDA Full unrestricted approval to remdesivir the next day), "well, since you are not strongly favoring either of those choices, you probably would be safer to go with recommending continuing to 390, leronlimab is a very small, under financed company that has never produced any revenue, Primary Endpoint did not achieve Statistical Significance in their Phase II m/m trials, and approval now may just be risky, let's not rush this". Maybe you could take another interim look at a reduced number before they reach 390?"
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