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Message: The FDA's highly arbitrary decisions

Correction to my previous post: At a cost of $50, Mil ~$50 K annually may not be affordable for many.

BTW-  I'm sure the following still holds true for Aducanumab:

"In EMERGE, the difference in the change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) was statistically significant in the high-dose group (change, —0.40 [23%]; P = .0101) compared to placebo. As well, significant differences were observed for the high dose compared to placebo in Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog 13) scores (change, —1.395 [27%]; P = .0098) and Alzheimer’s Disease Cooperative Study Activities of Daily Living scale for mild cognitive impairment (ADCS-ALD-MCI) scores (change, 1.7 [40%]; P = .0009)."

“The ability to hold onto activities of daily living…if you think about a 40% reduction in decline on the ADCS-ADL-MCI, you’re talking about people at a mild stage of disease still being able to work, bank, shop, travel, enjoy leisure activities for longer—I submit to you that this matters a lot more to our patients than what score they get on a memory test,” principal investigator Sharon Cohen, MD, behavioral neurologist, University of Toronto, said. “I also believe that results on this functional scale of daily activity translate better to our nonspecialist colleagues in medicine, our family physicians who bear the brunt of Alzheimer’s care, as well as to the non-medical community who struggle to understand clinical meaningfulness.”

https://www.neurologylive.com/view/new-analyses-suggest-highdose-aducanumab-reduces-clinical-decline-in-early-alzheimer-disease

 

Koo

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