Thursday, August 04, 2022 12:13:10 PM
Not correct. The naive GBM patients in the treatment armed received a original DCVax-L dose. The crossover was designed as a rescue dose for the patient that has recurrence. What that does is gives the patient a second dose that very likely affects their overall survival (OS). NWBO has repeated stated that that crossover dosing confound the OS data -- that creates significant bias in the trial in the favor of DCVax-L as they get more doses that the SoC control arm or any well-controlled trail used as a comparator. As stated in the protocol:
"All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression."
Patients were given DCVax-L as a rescue medication if they have a had recurrence (the PFS failure), not as a planned part of the treatment arm dosing schedule.
"All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression."
Patients were given DCVax-L as a rescue medication if they have a had recurrence (the PFS failure), not as a planned part of the treatment arm dosing schedule.
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