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Investor2014

06/22/21 11:50 AM

#316662 RE: abew4me #316644

Being stat sig over a placebo arm that includes standard or care is more difficult.

To then not get accelerated approval, based on suggestions made by the FDA, just shows that its not so easy to predict what the FDA will say to apparently excellent data.

Sometimes when it doesn't seem warranted the FDA say yes or decide opposite of the Aduhelm situation and then in rare disease with no treatment in children with short life expectancy.