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Re: Doc logic post# 661734

Friday, 01/05/2024 12:22:05 PM

Friday, January 05, 2024 12:22:05 PM

Post# of 724214

...because SOC no longer was fit for purpose or because of Fraunhofer’s claim that enrollment only occurred to the point statistically necessary.


That is really kind of ironic.

At that time there is no question the primary endpoint was PFS. There is no question that was failing badly (the K/M curve has been published), and almost certainly would have been declared futile by the DSM in 2015, And despite remaining blinded to the patient level data NWBO would have known the DSMB recommendation.

At which point there was no reason to continue to randomize into the trial because they had sufficient statistical evidence to answer the question. I.E., the trial failed. Not sure how Fraunhofer came upon this, or why they disclosed it. But it is clear the trial could not possibly have been a stat success at the time when the primary was failing badly.
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