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6 months ago
BRIEF-Tigenix receives positive feedback from the FDA on Cx601 global phase III trial protocol
March 7, 2017 / 6:14 AM / 6 months ago

BRIEF-Tigenix receives positive feedback from the 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

* Agency has agreed to an improved protocol for global phase III trial of Cx601

* 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

* FDA has agreed to accept fewer patients than originally planned in study, and has endorsed a broader target population that will ultimately facilitate recruitment process

* The global pivotal phase III trial for US registration of Cx601 is expected to begin in H1 of 2017.

* TiGenix is exploring further expedited pathways to accelerate submission and review process for its future BLA Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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