If this Q & A becomes a reality, it would demonstrate absolutely no compassion by the FDA to address the severe and tragic disease that Alzheimer's causes.
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Question: Do you rule out the possibility that the FDA would grant accelerated approval, with your one additional large study being designated a confirmatory trial, because A 273 appears to be active with super responders, and safer than the amyloid drugs, in a complex illness that has a great unmet need for beneficial drugs?
Doc's Answer: I think its very unlikely. Alzheimer is common and a larger study or two studies could have been done. Safety is good but not enough to get a drug approved.
(This is just shocking to me. If safety is good, why not give AA with an additional large confirmatory trial? This is just common sense in my opinion.)
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