The way I see it the company has agreed on a specific threshold for PCR reduction in n=72 patients at Week 35. They've termed this in the trial design as the "primary uPCR endpoint at week 35" (taken from the trial design poster). Obviously this will not be identical to the endpoint criteria for final analysis at week 104 but it's still an endpoint at that point in time with those number of patients (as I understand it) and be set in way that translates into the statistical likelihood that it either is or isn't possible for the final endpoint to be met (futility of the trial). Whether this is the difference in percentage of patients achieving FPRE on DMX vs placebo, or an actual threshold for reduction of PCR we don't necessarily know. We also don't know if they'll divulge any of that actual data next month. But there has to be a specific criteria that has been set and agreed on, otherwise there's no possible way of assessing whether the results are meaningful and/or have statistical significance at this interim stage. It has to be driven by data and not just a qualitative assessment.
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The way I see it the company has agreed on a specific threshold...
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