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DNA methyltransferase expression in triple-negative breast cancer predicts sensitivity to decitabine

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With respect to the applicant's assertion that TERLIVAZ significantly improves clinical outcomes, we note that the applicant provided evidence from data on file for the clinical study report of the CONFIRM trial that appear to consist of post-hoc analyses of patient subgroups, for example, improvement in renal function for patients with alcoholic hepatitis at baseline, and reduction in RTT requirements in patients who received a liver transplant