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Wednesday, August 03, 2022 1:42:46 PM
The ECA control guidelines address this. We’re simply repeating that and I expect that has been addressed in the ECA.
I positing a hypothetical doesn’t make it right, or correct and even in a real trial, the placebo are the placebo, not the treated group, and they go in there. The ECA placebo is statistically I expect quite consistent with the broad outcome. And if they were sicker than usual, the entire group was likely sicker than usual. That their disease was fast makes them less consistent with the broad statistical comparison if you are going to hypothesize they were sicker than typical patients and they would therefore make the results even better than normal if they were statistically most likely to be the control arm in such a trial that picked patients with larger than usual tumors at an early stage. Then the results here against an ECA of much healthier and less sick patients would actually demonstrate that DCVax-L performed better than is even shown by the current external control arm.
I positing a hypothetical doesn’t make it right, or correct and even in a real trial, the placebo are the placebo, not the treated group, and they go in there. The ECA placebo is statistically I expect quite consistent with the broad outcome. And if they were sicker than usual, the entire group was likely sicker than usual. That their disease was fast makes them less consistent with the broad statistical comparison if you are going to hypothesize they were sicker than typical patients and they would therefore make the results even better than normal if they were statistically most likely to be the control arm in such a trial that picked patients with larger than usual tumors at an early stage. Then the results here against an ECA of much healthier and less sick patients would actually demonstrate that DCVax-L performed better than is even shown by the current external control arm.
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