Isofol reports successful outcome from the scientific advice with the EMA
Isofol Medical AB (publ) has received positive feedback in scientific advice from the European Medicines Agency (EMA) regarding its candidate drug arfolitixorin (Modufolin®) intended for the treatment of advanced colorectal (colon) cancer. Thereby the significant parameters for the pivotal phase III study has been agreed upon with both the EMA and the FDA for the Marketing Authorisation Application (MAA) and a New Drug Application (NDA) for arfolitixorin (Modufolin®).The recent successful outcome of the scientific advice from the EMA and the successful completion of the End-of-Phase II (