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Published material on the related Pliva development codes PL-10, PLD-116, and PL-14736 has concentrated on preclinical wound, tissue-protection, and gastrointestinal-injury models rather than randomized human efficacy data, and the peer-reviewed record does not contain a confirmatory efficacy readout for the indications most commonly associated with BPC-157 in informal discussion

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Implant failure is exacerbated by the increase in antibiotic resistance among oral microorganisms

As proposed at 428.401(d), we noted in the CY 2025 PFS proposed rule (89 FR 61980) that we believe that it is necessary and appropriate for CMS to recalculate the rebate amount for an applicable period at regular intervals to include updated information about key data elements included in the calculation of the rebate amount, not limited to those data described in section 1860D-14B(b)(6) of the Act