Canada Approves Clinical Trial Application for Estelle® (E4/DRSP) Phase III Study


Liège, Belgium 20 July 2016 –  Mithra announces today that the Canadian authorities approved its Clinical Trial Application (CTA) for the Phase III study for Estelle® (E4/DRSP), the Estetrol-based product candidate in contraception developed by Mithra. This great news has been received a few weeks after the enrolment of the first patient in the Phase III study in Europe. Mithra should receive a feedback from the American Food and Drug Administration (FDA) in the next few days, as well as ethic committees, representing the last step before the launch of the Phase III study in the United States and in Canada.

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