Langostino, it is hard for anyone to disagree with your comment that "only the FDA and EMA matter." Furthermore, I won't in a general sense take issue with your observation that "we have to hope that the bar is set so low that approval won't be an issue even with mediocre-to-good data with excellent data for a small population." However, it is worthwhile to recall the height of the bar that Leqembi crawled over. It excluded 80% of the mild/moderate AD patients, and was thereby culled down to a group which achieved mediocre-to-good data. Anavex accepted 80%-90% of the patients who were available. Put another way, there is no data on 80% of relevant AD patients for Leqembi and the remainder are good-to-moderate, while blarcamesine scored good-to-moderate data for 80%-90% of the total relevant mild/moderate AD patients and excellent data for a subset thereof (in a significantly shorter period of time). This only covers the efficacy bar. Safety as well as the relevant incremental cost and convenience for patients didn't turn out to be a bar for Leqembi (at least in the US), and clearly blarcamesine scores far more favorably on those issues. (Boi has already pointed out that blarcamesine reduces brain shrinkage, and, unless I am mistaken, mAb's tend to accelerate that process.)
So, this is a long winded way of saying that I agree with you, but that I would note that if the bars are set fairly and equitably to what leqembi faced (and what donanamab likely faces), then they are clearly not insurmountable.
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