Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Kitov Says ISA Investigation Centered On DMC Associated With Phase 3 KIT-302 Study

Feb. 9, 2017 9:51 AM ET|About: Kitov Pharmaceuticals ... (KTOV)|By: Douglas W. House, SA News Editor
Kitov Pharmaceuticals (KTOV) reports that the previously announced investigation by the Israeli Securities Authority (ISA) is focused on matters surrounding the Data Monitoring Committee (DMC) appointed to monitor the data in the company's Phase 3 clinical trial of lead product candidate KIT-302. It says the DMC was established to analyze the preliminary results and determine the number of additional patients, if any, needed to show statistical validity and meet the primary endpoint of the study.

It adds that the data were analyzed by a European specialist services provider named Statistica Medica Ltd. Its analysis showed that the study met its primary endpoint. The company maintains that it will file a New Drug Application (NDA) in the U.S. by the end of next month. It will also continue all other ongoing activities.