NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

ae kusterer,

Yes, I think approval based on blinded data would be precedent setting but what if something very unusual was happening in this trial. For example, what if Kat's Cure experience of complete remission was not unique but being multiplied in a significant number of cases? Would a DMC or governing body potentially intervene and to what degree if they did? We know the Germans are very willing to intervene if placebo is considered inferior to treatment. Did they intervene first because of seeing something like this but then FDA withdrew the screening hold later once potential changes made in Germany passed the equivalency test and any potential reservations by FDA about changes made to L in process manufacturing were taken care of? Coincidently that might have happened right about the time that blinded PFS data would have been available and under review. Did NIH get involved in this whole process due to their own contamination problems that led to manufacturing changes of their cellular products which led to their patent involvement in the planned Phase 2 combo trials? I don't know for sure but I can't rule this out either. Best wishes.