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FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration not the injectable or subcutaneous routes that wellness clinics commonly use

Oral bioavailability of AOD-9604 has not been formally quantified in humans

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These proteins shield Cbl from degradation by stomach acid and enzymes, safeguarding its integrity during the digestive process