CorMedix(CRMD) - 2023 Q3 - Quarterly Report

As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the prespecified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safet ...