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Sunday, April 17, 2022 12:12:23 AM
The placebo arm was destroyed in multiple ways by regulator edict in my opinion based on numerous facts lining up to produce only one plausible conclusion. You have tried, others have tried but no one has another rational explanation that cannot be and if I read it was blown to smithereens, likely if I didn’t Biosect did.
First all patients in screening at the time of the halt were placed on treatment as placebo was no longer ethical (see also Geneva Convention). Next, if placebo is no longer ethical, the placebo being removed means that original placbos who had not evented were moved to treatment with DCVax. Finally the reduction in power caused by this has dramatic effect on the ability to show statistical difference even though it means all patients in the unadulterated placebo arm either evented and then moved to DCVax or evented and died. Only 3 patients even got resected a 2nd time.
Regulators did this to the trial, a trial in a rare disease which is universally fatal and has predictable deterioration in morbity leading to mortality. While this is usually adult onset and a malignancy, it has similar issues to Muscular Dystrophy. Zolgensma was approved with a single arm study in a handful of kids.
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