Friday, September 26, 2025 11:54:10 AM
Well, leighlogan, the approval of LEQEMBI (upon appeal) pretty much made the approval of Kisunla (upon appeal) a lock. With Blarcamesine objectively more efficacious in slowing the decline in cognition and far safer for the patient than either of those mAbs, as well as far easier and less expensive to deliver and monitor, it will now be extremely difficult for the EMA to reject its MAA. I say that before even considering the genomic result of much better cognitive preservation for carriers of (pre-specified) WT Sigmar-1 (i.e., ABCLEAR1 results), let alone the relatively stunning results for those (more than 70% of) WT Sigmar-1 patients who were also carriers of WT COL24A1 (i.e., ABCLEAR3 results).
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