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It remains under investigation in clinical trials registered on ClinicalTrials.gov and the EU Clinical Trials Register, and is not licensed for prescription or self-administration outside of formally approved research settings

Most research on BPC-157 for IBS is preclinical, conducted in animal models, and high-quality human clinical trials are lacking

Comment: Some commenters supported the cancer hospital payment adjustment while one commenter recommended the agency conduct a review to determine if the cancer hospital payment adjustment was still appropriate, including reviewing the accuracy of cost report information