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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

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Are they worried it may cut into the profits of their other drugs, such as NSAIDs, PPIs, and biologics

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Namely, it is always applied alone (Sikiric et al., 1993