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For individuals who have already obtained an unlicensed peptide, the safest course of action is to seek medical advice before use rather than attempting to store or administer the product independently

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[276] In public comments on the CY 2024 proposed rule, the manufacturer of Leqembi explained that Leqembi's Phase III confirmatory trial was already fully enrolled and complete prior to FDA granting accelerated approval, and as such, there was no RCT in which to enroll Medicare beneficiaries