Calliditas provides a regulatory update on EMA process for Nefecon
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2, 2022.In its review of the marketing authorisation application (MAA) for NEFECON, the CHMP has informed us that they will issue an additional list of questions related to manufacturing related information which will result in the opinion from EMA slipping into the second quarter. The continued review does not relate to the safety or efficacy of NEFECON, and