Without a formal statistical analysis of actual trial observations, then any statements from Don or the FDA are simply based on pre trial assumptions and not based on actual BETonMACE data. For example, the placebo group event rate, apabetalone effect, drop out rate, and other variables were all predicted/modeled based on past apabetalone trials and other CVOT trials in similar patient populations. This info was used to model BETonMACE. But without running analysis on the actual BETonMACE trial observations, then one simply cannot conclude that BETonMACE is unequivocally sufficiently powered.
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