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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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PV1-wt or PV1-BSOr 310 9 PFU were incubated in PBS either in the absence or presence of various reducing agents (5 mM) or of GSSG (5 mM) (Materials and Methods)