Replies to post #460174 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Nonsensical statements in light of LL's talk at the University of Miami on April 1.

[biosectinvestor]

This was in fact an adaptive trial, including the jumping from phase 1/2 to 3.

That you think something other than actual adaptation is necessary, is just you.

This trial was run as it was BECAUSE that was the requirement at the time, but the rules changed and the regulators were open to changing the adaptive trial to address the very reasons for the requirements/guidelines/policies changing. And why would they not? To be FORMALISTIC? That would be nonsense and cause patients to lose out both in the trial and in the long-run. It would serve no policy interest to run a regulator like you suggest except as a punitive game playing entity, which, while there are those who believe that is what regulation is all about, is not my view either of why regulation exists nor about how the FDA or any of the other regulators operate, but particularly not the FDA and I think the MHRA as well, at the least.

The thing is, that you not only posit that the regulator is stupidly rigid, but it MUST be stupidly rigid to make your predictions real. That is not the case, and particularly not in diseases and conditions like GBM.

[MI Dendream]

I clicked back, and am wasting time here but so be it.

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.