Santhera Pharmaceuticals (SIX: SANN) announces its intention to file an application for Conditional Marketing Authorization (CMA) for Puldysa (idebenone) for the treatment of respiratory dysfunction in Duchenne muscular dystrophy (DMD) with the European Medicines Agency (EMA).
Following scientific advice from EU regulatory authorities, completion and filing of the CMA for Puldysa in DMD is planned for the second quarter of 2019.
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