CorMedix Inc (CRMD)

[dshade]

"..the unblinded data for our Phase 3 LOCK-IT-100 clinical trial interim analysis based on the 28 CRBSI cases and recommended the trial be halted for efficacy as it had met the pre-defined criteria for stopping and no safety concerns were identified. We were thrilled at this outcome, which was the best case scenario for the Neutrolin study and it is an uncommon occurrence in Phase 3 development.

While we were optimistic that a positive interim analysis might occur given the available body of data for taurolidine Neutrolin, we believe this outcome is a remarkable achievement. In light of this achievement, we plan to seek the FDA agreement that we file an NDA based on a single clinical trial specifically LOCK-IT-100. Based on the DSMB’s recommendation, we have stopped enrollment activity for the trial and began the process of terminating the study in accordance with good clinical practice. The company has remained blinded to the specific results of the interim analysis to ensure that no bias is introduced while the trial is being terminated."

nice