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Within a 68-page briefing document for the committee meeting, the FDAs own experts wrote that there is a lack of evidence to make a conclusion on the effectiveness of BPC-157 for treating ulcerative colitis and there already are FDA-approved drugs available to treat ulcerative colitis, and they proposed not adding BPC-157 to the 503A Bulks List

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Nevertheless, this proposed mechanism lacks direct biochemical validation and relies heavily on circumstantial evidence from functional studies