Moberg Pharma intends to submit a registration application in Europe in 2021
STOCKHOLM, October 14[th], 2020, Moberg Pharma AB (OMX: MOB) announced today its decision to request pre-submission meetings with regulatory agencies, with the goal of submitting a registration application in the second half of 2021 in Europe.In June, Moberg Pharma presented topline results from the second of two clinical Phase 3 studies for MOB-015. In the European study – as well as in the North American study – the primary endpoint was achieved and no serious adverse events were reported. MOB-015’s superior mycological cure (percentage of patients who were fungus free) has now been