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Oxygen is a primary driver of oxidation, one of the major degradation pathways for peptides

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By delivering comparable weight loss results to injectable semaglutide in clinical trials, without the need for injections, it provides GLP-1 therapy as an option for patients who prefer oral medications or who have avoided injectables

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A plausible scenario, then, looks like this: Phase 3 primary completion in late 2025, NDA submission in the second half of 2025, FDA filing acceptance and review initiation in early 2026, and a PDUFA (Prescription Drug User Fee Act) action date likely in mid to late 2026