Tuesday, January 21, 2025 10:49:39 AM
Much better to have a smaller, successful phase 2b/3 in the endpoints EMA care most about, in which due to being smaller it's harder to have low p values than a 'proper' phase 3, that also has a fair amount of dropouts in the case of Donnanemab, that can in rare cases kill patients, causes ARIA, shrinks the brain without us knowing why yet and has less good ADAS COG and CDR vs placebo than Blarcamesine does despite having 18 months to have a gap versus 11 months for Blarcamesine.
Also in the case of Lecanumab, to appears to have been the case that participants would have been just as well of taking a placebo for 18 months then could have moved onto the drug and 18 months later (3 years in total) and be almost at same stage as someone taking it the full 3 years. In this case being better as an absolute measure than expected deterioration (though if this mattered most than Blarcamesine would be approved for RETT based on excellence trial absolute scores).
Meanwhile Blarcamsine it would appear one does need to take the drug as soon as possible as there is no catching up, we dont' know absolute scores yet.
Also Blarcamesine with added support in terms of safety from RETT and Parkinsons trials.
Also in the case of Lecanumab, to appears to have been the case that participants would have been just as well of taking a placebo for 18 months then could have moved onto the drug and 18 months later (3 years in total) and be almost at same stage as someone taking it the full 3 years. In this case being better as an absolute measure than expected deterioration (though if this mattered most than Blarcamesine would be approved for RETT based on excellence trial absolute scores).
Meanwhile Blarcamsine it would appear one does need to take the drug as soon as possible as there is no catching up, we dont' know absolute scores yet.
Also Blarcamesine with added support in terms of safety from RETT and Parkinsons trials.
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