Rhea-AI Summary
Moberg Pharma AB announced its intention to request pre-submission meetings with regulatory agencies, aiming to submit a registration application for MOB-015 in Europe in the second half of 2021. The Phase 3 studies for MOB-015 demonstrated significant mycological cure rates, with 70% in North America and 84% in Europe. This establishes MOB-015 as a potential leader in the onychomycosis market, addressing the need for safer topical treatments compared to oral terbinafine. The company also plans to discuss U.S. market strategies following the European meetings.
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