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Re: dennisdave post# 521818

Friday, 10/14/2022 2:35:28 PM

Friday, October 14, 2022 2:35:28 PM

Post# of 818652
As for measurements of efficacy, it will differ for other tumor types not encased in a skull, but also even for the combination trial, they have a whole slew of different additional measures and new tactics also for measuring PFS that were not the standard when the Phase 3 trial started, and you cannot change such a measure mid-trial, so they had what they had because pseudoprogression was not understood when that trial was started and the encasement in a skull made it particularly difficult at that time, relying just on scans at certain particular and early dates with no further protocol. Now they have a bit longer protocol for validation of PFS. Doesn’t take as long as OS, but it’s also not the only measure, nor the primary one.

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