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Re: iclight post# 610150

Sunday, 07/16/2023 9:51:20 AM

Sunday, July 16, 2023 9:51:20 AM

Post# of 823794
iclight,

Do you understand the process of a futility recommendation?; ). It’s a back and forth after given if given and if you recall NWBO submitted documents to the regulators who then decided not to enroll anymore SOC/placebo patients but continued to allow treatment patients to do so to their full prescribed number. The trial can be allowed to continue if it does no harm. The problem was that positive treatment effect was received by those who took L but not being received by those unwilling or unable to crossover so guess what they did?; ). Low and behold they allowed no more SOC/placebo patients into the trial because anyone not starting in the treatment arm or not crossing over was being harmed compared to the treatment first arm or crossover. That’s a big no, no in Germany. This action actually reduced the powering of this trial too. Now why would a regulator deliberately reduce the powering of a trial that they also only allow treatment arm patients to continue to enroll in?; )))). Hint, it’s not only because SOC is no longer fit for purpose which is the safe claim. Maybe the answer lies more in Fraunhofer’s claim that enrollment was only done to the point statistically necessary and that being backed up by JAMA Oncolgy publishing the Phase 3 DCVax-L (Murcidencel) results 7 years later. Hmmm. Best wishes.

PS. Just a friendly reminder. If you want to see this better step outside tomorrow morning into the daylight of a cloudless sky, open up your eyes and you will see it’s a new day.
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