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(1) Overview Epithalon is a synthetic tetrapeptide, also known as the AEDG peptide, composed of amino acids Ala-Glu-Asp-Gly

The REDEFINE 3 cardiovascular outcomes trial which will take several years to complete is not a prerequisite for initial market authorisation for obesity treatment, but its results will likely be important for subsequent label expansion and for establishing the cardiovascular benefit profile that has proven so valuable for tirzepatide and semaglutide

Orr-Walker BJ, et al

The regulatory distinction you made is so crucial: the July FDA advisory committee meeting on BPC-157, TB-500, KPV, and others is about compounding access through the 503A pathway, not approval, and not evidence of efficacy