You are attempting to prove that the COL24A1 WT results cannot be considered by the EMA for its blarcamesine MAA. To get there, you cite to a scenario of EMA guidance (5.4) where "The clinical data presented fail to establish statistically persuasive evidence in the primary analysis population but there is interest in identifying a subgroup where a relevant treatment effect and compelling evidence of a favourable risk-benefit profile can be assessed."
The problem with this argument is that its underlying assumption is untrue -- the clinical data show the primary endpoint ADAS-Cog13 met stat sig with a p value of under .025, as did the major secondary endpoint, CDR-SB. The ADL miss is not disqualifying, since this was an early AD trial, per NIA-AA criteria accepted by the EMA (and used by Anavex in the 2b/3). Further, if it were true that the ADL miss were disqualifying, CHMP would have already issued a negative opinion and not indicated to Anavex interest in receiving more data analysis, such as biomarkers, in a re-examination.
You also misattribute (to Section 4.6) and misunderstand how the term "credibility" is used by the EMA. It is a function of several elements, each contributing to the level of credibility achieved. The EMA guidance recognizes elsewhere that, for example, post hoc data may be considered in the context of a single trial, even though "replication" is also an element of credibility.
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