NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

Wrong! What happened in 2015 is what AVII77 said was the silver lining in case of failed PFS due to treatment induced pseudoprogression causing patients to live longer just like Dr. Linda Liau said apparently was happening with all patients in October of that same year. The reference was of course to the entire group which included a huge % of patients that were receiving the vaccine and the associated treatment induced pseudoprogression which she could obviously see was happening.
FDA May have initiated the screening halt but the Germans were the ones that didn’t let any more SOC/placebo patients into the trial. That has not been explained either because it essentially acts as a regulator green light for the treatment itself while commercial scale manufacturing and trial changes, needed to verify treatment effect, were put into place under the auspices of regulators. Those same regulators ALL “accepted” NWBO’s SAP which was then also used in the MHRA PIP trial plan.
The trial completion date was not updated because of the obvious need for manufacturing and probably to wait out guidance and possibly for 7 year data for ancillary evidence. Yes of course the data was the data at data lock but ancillary evidence can be added in for consideration of treatment benefit up until submission of BLA/MAA. Try again; ). Best wishes.