NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

If FDA or any regulator wants patient level data they can get it for comparison purposes because they have the authority to retrieve it even though NWBO doesn’t. They know patient level data is impossible without their intervention and since they also intervened by insisting on a crossover, which was the right thing to do for patients, the powering of the trial was also lowered by their action.
If regulators are indeed moving away from SOC comparators in deadly diseases out of ethical concerns then what they did with NWBO is all the validation they need because of the clear benefit seen in crossover patients. How they deal with future trials because patient level data is able to be retrieved in common data bases can’t realistically be applied to NWBO unless regulators themselves do the leg work and they know this. Hence all the workarounds that have been or are being created; ). Best wishes.