If you thought that Eli Lilly's donanemab could ensure a smooth regulatory flight in the slipstream of Eisai and Biogen, the FDA has other ideas.
The decision to call a last-minute advisory committee meeting last month for the Alzheimer’s disease med came as a surprise to Lilly’s donanemab team. Not for the request to discuss the therapy’s safety and efficacy, but for the timing of it.
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