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Priority review status, likely given obesity drug precedents, shortens FDA review to approximately six months rather than the standard ten to twelve months

While some peptides can influence hormone production (like growth hormone), they are a distinct class of therapy

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We made certain additional modifications to 413.79 in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53434), and we made changes to the section 5506 application process in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50122 through 50134)

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