Thursday, June 14, 2018 10:15:31 AM
I think it is important for Dr. Stupp to acknowledge his own conflict of interest in this regard. He was primary investigator for the Optune device (Novocure), which is a competitor for this new vaccine technology.
Additionally it should be pointed out that the primary endpoint for this trial is progression free survival. Progression free survival will not have any crossover effect because the event is calculated at time of progression.
Furthermore it should be known that many of the trials conducted including those Dr. Stupp has been an author of, utilize a date close to the date of surgery as the start date for the time variable of the Kaplan-Meier curve. So his criticism that one has to subtract the date of randomization from the date of surgery Is not accurate when comparing this data to historical standard of care analysis.
It was extremely unscientific for Dr. Stupp to state definitively, “the conduct of the trial makes it certain that we will never know”. How does he know this? This trial has not been yet been unblinded, and the full data has not been presented? This overstatement exemplifies Dr. Stupps own conflict because he erroneously states this without any supporting data of his own. He could have said this in a more honest and less definitive way, but he did not.
Discloser I have ownership in NWBO stock but have no relationship with the company and was not part of the NWBO DcVax-L trail.
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