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Aducanumab's Big Day Arrives, But How Much Will US FDA Panel Vote Matter?

Executive Summary

Agency thinks Biogen’s sucessful Phase III study supports approval, but given the negative outcome of another trial and disease-modifying mechansim of action, an advisory committee endorsement could go a long way in assuring the public the Alzheimer's drug actually works; the panel will comprise 11 voting members, four of whom were added as temporary members for their expertise in neurology, biostatistics and patient advocacy.

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