NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I had a chance to listen to the full audio of Dr. Linda Liau’s presentation at the University of Pittsburgh on 11/3/2022. There were a few statements about the DCVax-L Phase III trial that stood out to me:

(1) Dr. Liau directly stated that they will be “reporting out” the DCVax-L Phase III trial results at the SNO meeting later this month.

(2) Dr. Liau said that the FDA required them to have a crossover arm / option in the DCVax-L Phase III trial because the required leukapheresis procedure was invasive, and they had to give all of the trial participants the ability to crossover to receive the DCVax-L treatment, if their tumor progressed / recurred.

It would be unfair, illogical and unreasonable for the FDA to require a crossover feature in the DCVax-L trial, then turn around and penalize NWBio for allowing trial patients to crossover to DCVax-L after perceived progression.