Successful End-of-Phase 2 meeting with FDA and Phase 3 Program for Modufolin® agreed
Isofol Medical AB (publ), developing Modufolin®(arfolitixorin) as treatment for advanced colorectal cancer, has had a successful regulatory meeting with the United States Food and Drug Administration (FDA), an important milestone in the regulatory process.The successful completion of the End-of-Phase II meeting with the FDA marks the beginning of the final phase III study for Modufolin®, ISO-CC-007, which is set to commence in mid 2018 in the US and EU. Consensus with the FDA was reached on the significant parameters for the phase III study set to support a New Drug Application (NDA) for