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HyGro

08/01/22 2:59 PM

#500106 RE: GPha #499797

NWBO and clinicians had no reason to unblind recurrent patients. They had all signed an informed consent for a NAIVE GBM trial (the original protocol) and that protocol specified that EVERY patient that had recurrence would be offered a rescue treatment.

Here's the clinicaltrials.gov:
"All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)"

Otherwise they would drop out of the trial. There is NO need to unblind patients at anytime in this trial.