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Aducanumab Fall-Out: An Inexpedient Use Of ‘Expedited’ Review

Executive Summary

The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.

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