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FDA On What Aduhelm AdCom Got Wrong: Statistics, Investigational Drugs, Patient Perspective

Executive Summary

After a searing advisory committee on aducanumab, FDA reviewers undertook an extensive effort to counter or discount the panel’s criticisms, newly released review documents show. Among the unusual moves by the agency was the citation of data from two investigational products, Lilly’s donanemab and Biogen/Eisai’s BAN2401, as evidence in support of aducanumab.

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