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With respect to the applicant's assertion that TERLIVAZ® offers a treatment option for a patient population unresponsive to currently available treatments because among patients in the CONFIRM trial, patients that had failed prior therapy with available options achieved a statistically significant improvement in renal function with TERLIVAZ®, we note that the applicant provided evidence from data on file for the clinical study report of the CONFIRM trial Size:Capsules (30x500mg) Wellbeing Nutrition Skin & Hair Beauty Pack | Collagen, L-Glutathione, Hyaluronic Acid Plant Based Biotin Fo ti Extract (15 Effervescent Tabs + 30 Oral Thin Strips) Bogo https://domorpharma.mx/wp-content/uploads/2024/08/24-600x600.png

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