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exwannabe

07/15/23 7:31 PM

#610179 RE: supersteve13 #610166

Please prove that a futility recommendation occurred. :)


We know for a fact that an efficacy IA occurred in early 2015 despite continued denials by longs here. Per the JAMA paper in the SAP:

One of the two planned interim efficacy analysis was conducted in March 2015 after 56.4% of subjects had completed 6 months follow up.



We know that the endpoint for that was PFS. We know that PFS was clearly futile from the now published data.

And right after the DSMB conducts an efficacy IA that should result in a futility recommendation the FDA takes actions that are 100% consistent with a futility recommendation and no other known explanation.

I would also say the NWBO actions are 100% consistent with a futility recommendation.

The funny thing is that NWBO would be better off if they just came clean on the subject. Even I can say PFS futility did not make the drug a failure. But alas that might have "issues".