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Regulatory Submission & Approval Once a trial demonstrates efficacy and safety, sponsors compile results into a comprehensive regulatory dossier for submission to health authorities such as the FDA (U.S.), EMA (Europe), or PMDA (Japan)

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Patients with NAFLD are twice as likely to die of cardiovascular disease than liver disease as a result of these shared risk factors

BPC-157 is not metabolized by the CYP450 enzyme system in any documented pathway, which reduces the probability of major drug-drug interactions

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