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Re: kld2 post# 60514

Tuesday, 04/26/2016 7:51:59 AM

Tuesday, April 26, 2016 7:51:59 AM

Post# of 458802

I wonder if FDA would be willing to explore other primary endpoints, such as ADSC-ADL.



daily function and improved cognition remain a required combined feature for any pivotal trial design approved by regulators on both sides of the Atlantic.


ADCS-ADL measures function -

functional endpoint ADCS-iADL


http://www.fiercebiotech.com/financials/will-eli-lilly-s-11th-hour-regulatory-gambit-salvage-or-sink-its-alzheimer-s-drug?mkt_tok=3RkMMJWWfF9wsRokuKnMd%252B%252FhmjTEU5z17%252BktUaK%252Fg4kz2EFye%252BLIHETpodcMSspjNbrYDBceEJhqyQJxPr3HJdQN18R7RhHnDg%253D%253D&mrkid=%257B%257Blead.Id%257D%257D&utm_medium=nl&utm_source=internal

Dr. Macfarlane is not alone in his belief that function is more important than improved cognition -

Many of the clinicians in the field would far prefer to see an improvement in function, Schenk adds, with practical evidence that patients are better able to care for themselves day to day, than in cognition, where there's likely to be less agreement on the significance of an observed improvement as "different parts of the brain do different things."


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