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This helped ensure that every recommended option adheres to high standards of care and compliance

30 A 505(b)(2) sponsor who can patent a more efficient or greener manufacturing process gains a significant cost advantage that functions as a secondary moat after the primary patents expire

For example, the FDAs approval of Lillys ZepBound (tirzepatide for chronic weight management) in late 2023 was based on phase III data showing superior weight loss compared to placebo

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After detection of an abnormality on a CT scan, patients are immediately surrounded by an interdisciplinary support team devoted to their well-being