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Re: meirluc post# 730079

Monday, 11/04/2024 8:08:06 AM

Monday, November 04, 2024 8:08:06 AM

Post# of 818329

Was it not the FDA that mandated that placebo patients who
progressed have the option of receiving DCVax-L after progression?


Not per the trial SAP published in JAMA. Other sources have been inconsistent on this. And LP clearly said it was not an FDA decision, it was needed to enhance recruitment.

Regardless, that decision was for a P2 not designed to establish an OS efficacy benefit. The primary outcome was PFS and wold not be effected by crossover. It was NWBO that elected to repurpose an old quasi-dormant P2 into the P3. That is also why they used an outdated system for determining progression that was already known to fail in immno-onocology in GBM prior to the trial re-launch.
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