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10.1097/00006534-200005000-00019 81 NumataY.TeruiT.OkuyamaR.HirasawaN.SugiuraY.MiyoshiI.et al (2006)

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

Untreated, it can lead to neurological complications, and in serious cases, death