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Additionally, the applicant asserted that the Uretero1 TM decision makes clear that the lack of such evidence comparing the nominated device to other disposable devices does not and should not preclude an applicant from meeting the substantial clinical improvement standard

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Only a small number of pilot studies have examined BPC-157 in people, and controlled clinical data are scarce though this is an evolving area, with at least one registered placebo-controlled Phase 2 study of BPC-157 in acute muscle-strain recovery now on record

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