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Posted On: 10/17/2020 2:49:58 PM
Post# of 148985
IMO, EUA will be granted next week.
However, if we are to continue with our Phase III s/c trial, that does not mean that then we will have to go to 390 enrollment, then wait 28 days for last patient to be injected, and then wait 2 to 3 weeks for conclusive Top Line Report analysis/publication.
Another Interim s/c analysis could be performed when enrollment get to 235 or 250 or 260 and these bigger numbers increase probability of statisical significant p value.
We were at 221 as of October 7th, maybe we are now at 240, 245???
Maybe the DSMC is presenlty adding patients beyond our 195 to an update Interim analysis?
However, if we are to continue with our Phase III s/c trial, that does not mean that then we will have to go to 390 enrollment, then wait 28 days for last patient to be injected, and then wait 2 to 3 weeks for conclusive Top Line Report analysis/publication.
Another Interim s/c analysis could be performed when enrollment get to 235 or 250 or 260 and these bigger numbers increase probability of statisical significant p value.
We were at 221 as of October 7th, maybe we are now at 240, 245???
Maybe the DSMC is presenlty adding patients beyond our 195 to an update Interim analysis?
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