Moberg Pharma announces regulatory submission to FDA for North American phase 3 study
Moberg Pharma AB (publ) has submitted regulatory filing for the next clinical Phase 3 study for MOB-015 (nail fungus treatment) to the U.S. Food and Drug Administration (FDA).The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The company expects to start enrolling patients in the second quarter of this year. The study design builds on the experience gained from the previous