Linda is saying that no one wants to release their patient level data and the FDA guidance says that is the ideal way to move forward. There was no way for NWBO to get patient level data to compare with their own. Pretty simple really. The adjudication of this L Phase 3 can only be done with next best data and that includes the fact that historical comps have not changed much over many years in this disease and the use of generally matched comparators by an independent group not associated with NWBO was tested various ways for bias with non found. You can attack the method all you want but the method itself was externally checked by independents and passed muster; ). The bear arguments… not so much; ). Best wishes.
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