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Butler L, Perone Y, Dehairs J, Lupien LE, de Laat V, Talebi A, Loda M, Kinlaw WB, Swinnen JV

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Maintain aseptic handling to preserve compound integrity.

FDAs 2023 Category 2 placement cited immunogenicity risk for certain routes of administration, peptide-related impurities, complexities in active pharmaceutical ingredient (API) characterization, and limited safety information for the proposed routes

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