"As far as I can tell from the recent data PR, the results presented was based on Completer rather than ITT population analysis accounting for dropouts. I have doubts if that will wash with the EMA as reliable results from a proper RCT."
Well how can they give the results at 48 weeks as pre-specified time point on participants who haven't completed the trial to 48 weeks? (either dosed or placebo).
Completer analysis isn't a post hoc, Donnenamab gave their results based on 76% completion was that a post hoc too? It got FDA approval.
"The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study."
It doesn't say a full blown phase 3 study just a "confirmatory study". Anyway, since then FDA have changed their guidance so ADL is no longer required as it is too hard to show on early AD which hadn't been announced by FDA at this time.
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