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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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Size:Capsules (30x500mg)
Following centrifugation, the pellet was dispersed in 1.5 mL of 2 N HCl/MeOH/CHCl 3 (1:3:6), vortexed, and allowed to separate
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