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AOD9604 and Oral Bioavailability Research Pharmacokinetic profiling in pigs confirmed that AOD9604 is orally bioavailable, with intact peptide and its principal N-terminal truncation degradants (2aa and 3aa fragments) detected in plasma following oral dosing

Response: Although we acknowledge the applicant's concerns regarding the descriptor for C1739, we do not agree that the device category code should be withdrawn and replaced with a new code effective January 1, 2026, for the following reasons: First, per the applicant's request prior to CY 2026 rulemaking, CMS revised the descriptor for C1739 to read, effective October 1, 2025: Tissue marker, uniquely detectable and identifiable with probe/sensor, any method (implantable), with delivery system

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