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Monday, June 28, 2021 2:26:07 PM
I've not really followed CVM. I'm curious, out of the 923 trial patients, does anyone know how many of them ended up in the subgroup that the company intends to seek approval on? This would be the group that didn't receive chemotherapy treatment (but yet received SOC?).
To be clear about the populations.
The trial decided at entry if patients would get chemo as part of SOC or not based on the nature of the cancer. Patient fairly low risk would not get chemo. Then everybody was randomized for Multikine or not.
EDIT: I think I have the order of the above reversed.
Per a Gert tweet, the non chemo (low risk) group was about 50%. I do not believe this at all. It should be more like 20%.
That is not the real issue there though. There is no hint this was any sort of also assigned analysis. And the primary analysis failed. And likely failed bad.
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