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everything else is uncontrolled No approval process underway : no sponsor has pursued formal approval Quality concerns : peptide impurities and characterization challenges in unregulated manufacturing The economic reality: Unpatentable peptides cannot justify the $50100M+ investment required for Phase 3 clinical trials, which is why BPC-157 has peer-reviewed preclinical data and one underpowered controlled trial rather than a development programme

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The effects of Melanotan-2 peptides on receptor function and cell signaling have been extensively studied