if you go for Complete MA, isn't it still very possible that the regulators will approve with conditions anyway
IIRC, "conditional approval" under the EMA is very similar to "accelerated approval" under the FDA. I believe neither are differentiated from regular approvals with respect to label conditions, which are imposed as needed under any of the approval pathways.
The extra "condition" with respect to the EMA conditional approval is the requirement to conduct a post-approval trial.
In both the EMA "conditional approval" and FDA "accelerated approval" pathways, the drug sponsor is asking the agency to rely more on biomarkers as surrogate endpoints since the trial's results for direct clinical outcomes may not be sufficiently persuasive. I'm not sure how much weight would be placed on blarcamesine's great brain-volume-loss data under the complete approval pathway compared to the conditional pathway.
I'm no expert either, but (unless the OLE data changes things) I saw the P2b/3 clinical outcomes as borderline approvable, with the biomarkers very -- especially re brain volume -- persuasive, enough to get 2-73 across the finish line. If my interpretation of the different approval types is accurate, then Missling and Jin must find the clinical outcomes more persuasive than I find them, or the OLE data will be a very enjoyable reveal for us. Or maybe they figure the biomarkers will be given enough weight even under complete approval. Or they're foolishly taking a chance because complete approval is better for marketing. (I suppose it could also be Missling persisting in playing cheaply and not wanting to pay for an additional trial -- but that seems too foolish in this context even with his propensity for thrift.)
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