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Within a 68-page briefing document for the committee meeting, the FDA’s 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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244 This process is particularly important in conditions such as diabetic microangiopathy, where altered SUMOylation dynamics can affect pathological angiogenesis
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