Doc — really appreciate the regulatory context you laid out. The Vectibix example actually highlights how different that situation was: multiple trials, large N, SAP amendments before unblinding, and FDA approval already in place. None of that maps to A273, which has no replication, no prespecified ABCLEAR3 biomarker population, and no U.S. approval to anchor EMA.
I also dug around and couldn’t find a single case where EMA approved a non-FDA drug based on a post-hoc genetic subgroup. Durvalumab (Imfinzi) is the closest analogy, but that was FDA-approved first and based on a protein marker, not a GWAS-derived genetic slice. It really reinforces your point that this is essentially unprecedented, and that EMA almost always acts as a follower rather than a leader on new MoAs, especially in neuro. I guess the cost and safety advantages just don’t trump efficacy and robustness in this setting.
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