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Absent additional guidance, we believe that hospitals have the capability to report this market-based data for cost reporting periods ending on or after January 1, 2026

Key mechanistic features: Pulsatile GH release: Maintains natural GH secretion patterns rather than constant elevation Feedback preservation: Does not override normal hypothalamic-pituitary feedback loops IGF-1 elevation: Secondary increase in insulin-like growth factor-1 (IGF-1) through hepatic stimulation Lipolytic effects: Documented reduction in visceral adipose tissue (VAT) in clinical trials Tesamorelin FDA Approval History The Egrifta FDA approval timeline represents one of the few success stories for peptide therapeutics reaching market authorization