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Re: meirluc post# 505233

Monday, 08/15/2022 7:18:39 PM

Monday, August 15, 2022 7:18:39 PM

Post# of 747581
Maybe the delay in release of the JA is related in part to the difficulty of comparing the excellent survival results of the 64 crossover patients with the much less stellar results of the ECAs because only 64 of the 99 non treatment patients (64.6% were robust enough to crossover and hence represent a group that had it received only SOC, would have had a somewhat better result than the ECAs. A comparison to the ECAs could therefore represent statisticians with a problem. I don't know if a comparison could be made between the survival results of the 64 crossover patients and the survival results of the top 64.6% survivors of the ECAs

Having said that, I strongly believe that the more robust 64.6% of the ECAs would not have anywhere near the survival record displayed by the 64 crossover patients in the phase 3 trial. The challenge is to use acceptable statistics that document in a JA, the survival superiority of the 64 crossover patients. Hopefully that can be done by comparing the crossover patients with the more robust patients in the ECAs.
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