NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Great post, I was about to answer another post on a similar topic, but I think you covered it well. I would add that by the time of the halt without being unblinded NWBO had to know that the only way PFS could be made into a valid endpoint is if they could go back to every patient deemed to have progressed and determine who had actually progressed and who had pseudo progressed. I don't think they could find a way of doing this, and at that time they worked on getting the regulators to base the entire trial on OS, and also compare with historical data while immediately crossing everyone over to DCVax-L.

The company didn't need to be unblinded to know that this had to be done, and the agreement to do it was made during the halt but took year to document to the regulators satisfaction. The regulators have not fully documented it to this day.

Gary