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Four of the 19 refined hits were common to both XChem screens, although the binding pose of two of the hits had changed substantially (Table 3

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Second, while we concurred that avoiding post-cystoscopy infections is important, we noted that none of the studies the applicant submitted as evidence evaluated or assessed the VersaVue [TM] Single-Use Flexible Cystoscope and that none of the studies compared clinical outcomes, such as adverse events (including post-cystoscopy infection) associated with the use of the VersaVue [TM] Single-Use Flexible Cystoscope to clinical outcomes associated with reusable cystoscopes

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