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frrol

06/28/20 8:50 AM

#256616 RE: Investor2014 #256607

Some good points.

Having done OLS statistical analysis for complex econometric models, I can say that subgroup stratification doesn't take much more time. With sophisticated statistical software packages like SAS it takes a couple hours. With Excel, it takes a couple more hours. This is not to say that data analysis only takes hours. The marginal difference in stratifying data among multiple cohorts is only hours. The entire effort can take weeks, and then there is of course weeks for review and audit.
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XenaLives

06/28/20 9:14 AM

#256622 RE: Investor2014 #256607

Stat sig topline results are not necessary for approval.

Substantial relief where there is none for all patients will be adequate.

We are not dealing with typical symptomatic treatment here, the MOA addresses the root cause of the dysfunction, cellular homeostasis, so I expect benefit to be wide spread.

The scenario I have in mind is that about 25% of patients across treatment arms may respond well, which is unlikely to yield stat sig topline results.