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Furthermore, BPC 157 therapy in severe conditions involving multiple organs and vascular failure in counteracting occlusion/occlusion-like syndrome as a whole offers illustrative examples of how the risks associated with this complexity can be managed or resolved

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FDA’s stated rationale is still published there: compounded drugs containing BPC-157 “may pose risk for immunogenicity for certain routes of administration” and may have complexities regarding peptide-related impurities and active pharmaceutical ingredient characterisation, and FDA “has identified no, or only limited, safety-related information for the proposed routes of administration” [10]