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Wednesday, November 09, 2022 8:45:32 PM
I don't think anyone knows that exactly who and what patients were suddenly given something breaking the set protocol. I actually don't think they would do that. I think rather, no more patients were put onto the placebo arm and patients already enrolled were put onto the treatment arm and that the company was not informed, because to inform them limits their options.
I believe that the Germans initiated the partial halt, but don't know it for sure. I do think they do not like human experimentation for no purpose, and once you have so many crossed over and no more placebo arm, I would think for the Germans, delaying the treatment of patients, at least in Germany, when that placebo arm would effectively be useless if everyone crossed over, which they likely seemed to realize, would be problematic from an ethical perspective for the Germans particularly. But I don't know that is what happened.
The Germans did a deep dive on the study, they had not too long before that partial halt, given the program the Hospital Exemption (the "HE"), which only came after a very deep review of the trial. Further, the German authorization for the HE not only covered glioblastoma, but gliomas and a broader range of tumors, which was very interesting.
I believe that the Germans initiated the partial halt, but don't know it for sure. I do think they do not like human experimentation for no purpose, and once you have so many crossed over and no more placebo arm, I would think for the Germans, delaying the treatment of patients, at least in Germany, when that placebo arm would effectively be useless if everyone crossed over, which they likely seemed to realize, would be problematic from an ethical perspective for the Germans particularly. But I don't know that is what happened.
The Germans did a deep dive on the study, they had not too long before that partial halt, given the program the Hospital Exemption (the "HE"), which only came after a very deep review of the trial. Further, the German authorization for the HE not only covered glioblastoma, but gliomas and a broader range of tumors, which was very interesting.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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