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Doc logic

03/07/24 9:17 PM

#677207 RE: sentiment_stocks #677190

sentiment_stocks,

In the treatment arm it doesn’t matter as much to make a determination about treatment effect since pseudoprogression is part of a reaction to SOC and L is additive to that as long as there is a fair comparison to SOC/placebo pseudoprogressors without L added into the mix. That wasn’t happening in this trial because of improper progression diagnosis and move to L. Another issue is that late pseudoprogressors do better than early pseudoprogressors so late pseudoprogressors from SOC/placebo might be expected to do exceptionally well with L added thus skewing results even more. Hence the possible need for blinded sensoring of SOC/placebo pseudoprogressors to determine true treatment effect which could only be done with ECAs and true progressors being classified as rGBM to measure treatment effect on them. This turned out to be very significant as we all saw from the data. Best wishes.
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GermanCol

03/11/24 4:10 PM

#677862 RE: sentiment_stocks #677190

I never said or implied they could detect psPD in the 99 arm and not in the 232 arm. What I said is that in the 99 patients arm, all patients that were pseudo progressors, that were additionally thought to be progressors and, as consequence of that, crossed over (and started to recieve DCVax L) had to be censored not only for PFS, but also for OS. And that is because they were not SOC-only patients anymore, they started receiving DCVax from pseudoprogression, so their OS could not be used for the purpose of comparing against SOC after that. On the other hand, that is not the case for the 232 patients arm, because anyway they were receiving DCVax from the beginning. So for the case of this arm, they needed to be censored for PFS, but not for OS.

The whole explanation is in my answer to Ex. Post 677821