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Sunday, November 28, 2021 8:03:13 PM
Progression is a surrogate endpoint. Surrogates are believed to adequately correlate with the true endpoint which in the case of GBM is death. If survival is positive on the original design but progression only trends, it is statistical garbage rules that cast doubt on efficacy, not the data itself. A p value of 0.06 says there is only a 6% chance vs a 5% chance the outcome you see is actually just chance. But the p=0.06 gets rejected…crazy stuff to most clinicians.
I think we see positive across the board if IDH mutation is accounted for and if not then 5 out of 6 with the 6th trending close to positive (non-adjudicated PFS) when all is said and done. Most patients that survive never progressed according to LL.
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