FDA Feedback on SPA Estelle®: a New Step Closer to the Launch of Estelle® Phase III Pivotal Clinical Studies

  • Mithra received feedback on the SPA (Special Protocol Assessment) of the FDA (Food and Drug Administration) regarding its Estelle® Phase III Protocol.
  • At the clinical protocol level, only minor recommendations and requests for clarification were expressed by the FDA.
  • This feedback is comforting and in line with objectives and remains on Estelle® Phase III schedule.

Liège, Belgium 05 April 2016 After receiving encouraging news from the different European countries regarding the Estelle® Phase III pivotal clinical studies under approval, Mithra Pharmaceuticals announces today that the FDA (Food and Drug Administration) also gave encouraging feedback regarding the Estelle® Phase III pivotal clinical study protocol in the United States. Mithra already has the answers at its disposal and will provide them through the IND (Investigational New Drug) submission as planned in the course of June 2016. At the clinical level, only minor recommendations and requests for clarification were expressed by the FDA.

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