Replies to post #402014 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Yes, this would help to explain the clinical hold on the DCVax-L clinical trail on 8/15/2015. There was a lack of true Equipoise, and it did not make any sense to continue to randomize newly diagnosed GBM patients to the control / placebo group.

In my opinion, it is obvious that there was early FDA buy-in to the revised SAP, and the revised Primary and Secondary Endpoints.

In fact, I believe the FDA recommended to Dr. Linda Liau and NWBio for them to use External Control Arms to augment the control group data in the DCVax-L Phase III trial.

I also believe that the FDA was instrumental in getting the other regulatory agencies (UK, Canada, and the EMA) to buy-in to the revised SAP and the revised endpoints.