Replies to post #460209 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

MI D, remember when the trial began the primary goal had been PFD, patients who weren't on the vaccine were to cross over after progression. If it hadn't been for pseudoprogression perhaps the trial could have been judged years ago based on PFD with limited OS data.

We really still don't know how well we've done with PFD, whether patients who may still be alive, but were viewed to progress many years ago have been reevaluated and determined not to have progressed at all.

To me, this is the real flaw in the original trial design, effectively you lost the control group once progression was called. The company was wise enough not to chance that there was a significant difference between when progression was called for the control, and when it was called for those who received the vaccine up front. Perhaps it could have led to approval years ago, but it also could have led to a failure and we'd never really learn the survival advantage. The changing to OS as the primary goal was the right move, the only real question is whether they could have gotten the regulators to sign off earlier in the process. I believe the regulators took much longer to finalize the SAP than anyone thought they would. The FDA is changing, but change in the FDA makes a snail or turtle look like it's a supersonic jet in comparison.

Gary

[sukus]

So true MID. The shorts think we don’t know statistic. Of course regulators know what is golden standard in statistic.



“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. “

[exwannabe]

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.

Your assertions of facts regarding exactly what happened in summer of 2015 is pure speculation, not fact. It is in disagreement with multiple statements by NWBO.

The idea that the FDA secretly crossed the entire un-progressed patient population is impossible. Every un-progressed patient (even those on treatment) would have had to be given the option. That is a hell of a lot of patients and docs who had to be informed.

There is more yet! That would terminate the PFS primary as all patients would be censored then (OS could go on). That means you are accusing LL of lying when she said they were waiting on PFS events

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