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BioWorld - Sunday, July 27, 2025
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Home » Apocalypse later? Lilly CRL for donanemab in AD no bombshell, phase III data key
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Apocalypse later? Lilly CRL for donanemab in AD no bombshell, phase III data key

Jan. 20, 2023
By Randy Osborne
Eli Lilly and Co.’s complete response letter (CRL) from the U.S. FDA relating to accelerated approval of Alzheimer’s disease (AD) candidate donanemab set off a round of speculation regarding not only what the move might mean for the pharma giant but also for others in the embattled therapeutic space and beyond. The answer, if you believe analysts: not much.
BioWorld Regulatory Neurology/psychiatric FDA

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