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boi568

12/26/23 8:31 PM

#444258 RE: Steady_T #444256

Obviously a full EMS review has not yet occurred. But I am making the assumption that they will have already screened for stat sig. I can't see the EMA wasting resources on a non stat sig trial outcome.
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WilliamMunny

12/26/23 9:48 PM

#444271 RE: Steady_T #444256

Steady, Missling said the EMA had seen "the data which has not been published." He did not say "data that has not been published," implying that it could have been only some of the data. I read that sentence from him as meaning the full data.