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BRIEF-Tigenix receives positive feedback from FDA on Cx601 global phase III trial protocol
March 7, 2017 / 6:10 AM / 7 months ago

BRIEF-Tigenix receives positive feedback from FDA on Cx601 global phase III trial protocol

March 7 (Reuters) - Tigenix Nv:

* Tigenix receives positive feedback from the FDA on Cx601 global phase III trial protocol

* Tigenix NV - received positive feedback from U.S. FDA on an improved protocol for its global phase III trial for treatment of complex perianal fistulas

* Tigenix NV - FDA has agreed that BLA could be filed based on efficacy and safety follow-up of patients assessed at week 24, instead of week 52

* Tigenix NV - FDA has agreed to accept fewer patients than originally planned in study

* Tigenix NV - global pivotal phase iii trial for U.S. Registration of Cx601 is expected to begin in first half of 2017

* Tigenix NV - is exploring further expedited pathways to accelerate submission and review process for its future BLA Source text for Eikon: Further company coverage:

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