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Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

How Sarepta And Biogen Are Following The Actimmune Playbook

Executive Summary

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

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