"Is the P value goin to be strong enough with such
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Posted On: 12/08/2021 11:23:05 AM
"Is the P value goin to be strong enough with such small numbers ? This is part of the problem we ran into with CD12."
My couple of thoughts about lowering the enrollment numbers in Brazil are that this is great news first of all, to getthis approved by Anvisa.
The DSMC peek at 15 patients, I think confirms a theory of mine. That is, we are expecting such good numbers from 700mgIV, followed by 3 x 700mgSQ treatments.
I am not suggesting that we will hit Stat Sig at interim or full enrollment, but if we show anything like 82% survival, at not just day 14, but also at days 21, and 28...AND...and we have a BTD in mTNBC from US FDA, topline numbers from NASH and filed BTD for NASH with US FDA, than Anvisa may just say, "Let's do this. We don't need to see anymore."
Again, I'm not saying the reduction in overall enrollment will result in Stat Sig, but I am saying that maybe it is not a mistake.
Best of Luck,
chazzle
My couple of thoughts about lowering the enrollment numbers in Brazil are that this is great news first of all, to getthis approved by Anvisa.
The DSMC peek at 15 patients, I think confirms a theory of mine. That is, we are expecting such good numbers from 700mgIV, followed by 3 x 700mgSQ treatments.
I am not suggesting that we will hit Stat Sig at interim or full enrollment, but if we show anything like 82% survival, at not just day 14, but also at days 21, and 28...AND...and we have a BTD in mTNBC from US FDA, topline numbers from NASH and filed BTD for NASH with US FDA, than Anvisa may just say, "Let's do this. We don't need to see anymore."
Again, I'm not saying the reduction in overall enrollment will result in Stat Sig, but I am saying that maybe it is not a mistake.
Best of Luck,
chazzle
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