Monday, July 13, 2020 9:23:16 PM
This is what happened with Cormedix.
Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. The company will submit the results of the interim analysis to the U.S. Food and Drug Administration for its review.
http://www.cormedix.com/cormedix-inc-announces-positive-results-neutrolin-phase-3-lock-100-study-based-recommendation-independent-data-safety-monitoring-board/
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