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03/13/24 4:32 PM

#678375 RE: exwannabe #678367

exwannabe,

What I stated about missing data is obvious and is well explained by what would have been expected to occur with late pseudoprogression or any other reason for crossover by SOC without true progression first. The reason for regulators deliberately lowering the powering of this trial by pressing NWBO to leave out 17 SOC/placebo patients while all treatment patients were enrolled is also obvious when taking into account that all those or almost all missing were from Germany, you know, the ones who don’t like experimentation with known lesser treatments on their people (ie Fraunhofer’s claim that enrollment occurred to the point statistically necessary). By the way, low absolute lymphocyte count patients enrolled in SOC/placebo only in Germany would not have done very well compared to those enrolled in the treatment arm as those low ALC patients typically event much sooner. Data showed that some low ALC patients were among the longer lived patients. That is a discrepancy that likely showed up quickly.
Just because you don’t like the way this data has been handled or the way the trial was set up does not mean that the trial was set up, or other actions taken, without the best possible outcomes for patients clearly in mind. The set up in this trial clearly helped as many patients as possible benefit as the long tail in GBM and rGBM data clearly shows in peer reviewed data, methods and conclusions. Best wishes.