I’d like to see a large RCT to definitively answer function, subgroup efficacy (ADCLEAR1 vs ADCLEAR3), and biomarkers (brain atrophy, p42/40). In oncology and even with donanemab, regulators have often allowed approval first with a confirmatory trial. Given blarcamesine’s safety profile and cognitive benefit, I’m wondering what criteria CHMP uses to decide between granting approval with a confirmatory trial versus requiring a new trial upfront — curious how you see it?
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