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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)