Terrific post and you really seem to know what you are talking about
A company investing so much money in a trial without thought in advance to how the data would be analyzed would just be incredibly sloppy (and hopefully not the case for NWBO)
Simply described: Ofcourse they had. Their first focus was more toward PFS, as any other sponsor would working in the field NWBO is working in. Then you got the pseudo-problems. And now the focus is most probably more in the direction of OS then PFS (as an endpoint)
For this a new SAP was needed. Again I expect the endpoints in the SAP to be accepted by the FDA. But it remains uncertain to the market then if the new endpoints were the direction when the trail was designed in the first place.
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