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(2021) 106:e1071e83

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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Specifically, we identified Lactobacillus murinus as a bacterium that produces high levels of GSH when provided with sufficient L-NAC as a substrate