CDiddy Are you saying that our is an Adaptive Tri
Post# of 148183
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Posted On: 10/25/2020 4:59:36 PM
Re: ClosetInvestor #63161
CDiddy
Are you saying that our is an Adaptive Trial, thus we can change the Primary Endpoint, in this case, to morbidity at 42 days from the original 28 days....?
And then also??
That the DSMC could look again at our 195 Interim which they recently unblinded (for the DSMC only), and see/calculate new p value that could lead to recommended FDA approval, presently, soon???
Are you saying that our is an Adaptive Trial, thus we can change the Primary Endpoint, in this case, to morbidity at 42 days from the original 28 days....?
And then also??
That the DSMC could look again at our 195 Interim which they recently unblinded (for the DSMC only), and see/calculate new p value that could lead to recommended FDA approval, presently, soon???
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