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Re: learningcurve2020 post# 384430

Monday, 06/14/2021 9:04:48 AM

Monday, June 14, 2021 9:04:48 AM

Post# of 700013
When they amended the protocol to increase the size a bit and change the PFS trigger to 248, the also split the alpha between the primary PFS endpoint and the secondary OS enpoint. The study was now powered to detect a difference at 98% certainty (p=0.02) rather than the original 95% certainty (p=0.05). By doing so, they elevated the OS endpoint. There is your reason. Need I post the PR?

None of this need be done with an interim efficacy analysis. Everyone who bother to do basic DD knows that no interim efficacy analysis was ever performed.

Not even a nice try LC.

Reading the old comments everyone who trashed AF ultimately got it all wrong with Germany and the rest.

Do we know exactly when the DMC dissolved?

>>adamfeuerstein Comment

You don't resize a study without a reason. And the DCVax study wasn't just resized, it was radically altered by increasing by 125% the number of PFS events required for the final analysis. If you believe these changes were made without an interim analysis, you know nothing about clinical trial design and conduct and should not be invested in biotech or drug stocks.

NWBO issued two press releases in which it stated clearly, definitively, that an interim efficacy analysis was underway. It's been almost a year, where are the data?

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