S/C Positive But if No SS So what happens if Phas
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Posted On: 10/15/2020 11:18:52 AM
S/C Positive But if No SS
So what happens if Phase III s/c interim barely misses Statistical Significance, in other words, results are very good, and also, if Secondary Endpoints are all very good, with many achieving Statistical Significance?
Might they grant FDA EUA, or is it absolute that Primary Endpoint "MUST" be met?
I've wondered why FDA is also looking at the s/c unblinded data? Maybe they are trying to "justify" granting EUA or general full approval, considering also our eIND results and the global rise in new cases????
So what happens if Phase III s/c interim barely misses Statistical Significance, in other words, results are very good, and also, if Secondary Endpoints are all very good, with many achieving Statistical Significance?
Might they grant FDA EUA, or is it absolute that Primary Endpoint "MUST" be met?
I've wondered why FDA is also looking at the s/c unblinded data? Maybe they are trying to "justify" granting EUA or general full approval, considering also our eIND results and the global rise in new cases????
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