Anavex Life Sciences Corp (AVXL)

[boi568]

Credit to Liliy posting on Stocktwits, who found EMA guidance "on the investigation of subgroups in confirmatory clinical trials":

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf

The guidance addresses the "'Credibility' of a subgroup finding" and allows the EMA to consider subgroups that have not been pre specified:

"Knowledge available when planning the trial will inform the choices that are made for which factors are used to stratify randomisation or analysis, and which further subgroup investigations are planned (Section 6). Such pre-specification, reflecting that there is plausibility for differential outcomes between subgroups, can lend credibility to positive or negative subgroup findings. Conversely, the absence of pre-specification cannot be taken as a direct argument that results in a particular subgroup lack credibility. In particular, for adverse findings in subgroups there should be no disincentive to properly consider and pre-specify all relevant subgroups at the planning stage. Instead, arguments for lack of credibility should focus on biological plausibility and (absence of) replication." At pp. 10-11.