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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

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173 PalikarasK.TavernarakisN

Both peptides maintain stability across the same pH range (4.0-8.0), so there are no compatibility concerns in the blended format