A submission has already been sent to the Swedish Medicinal Products Agency. Additional submissions will be sent to other European countries. The study is proposed to include approximately 300 patients at 30-50 European clinical sites in 3-5 countries.
Elisabeth Lindner, CEO of Diamyd Medical, said: “We are looking forward, through the coming national applications, to the gradual inclusion of more European countries and diabetes clinics in the European Phase III Study.”