- TiGenix NV (NASDAQ:TIG) announces that it will submit responses to the Cx601 Marketing Authorization Application (MAA) Day 180 List of Outstanding Issues (LoOI) from European regulators in August.
- Submission of responses to the Committee for Medicinal Products for Human Use (CHMP) Day 180 LoOI is part of the standard regulatory procedure, under which on Day 181 the European Medicines Agency (EMA) continues the review of a file following a clock stop. A CHMP opinion is expected in October and the Company expects to receive a Marketing Authorization decision in Q4.
- Cx601 has been developed for the treatment of complex perianal fistulas in Crohn's disease patients as a first indication. The company licensed it to Takeda Pharmaceutical (OTCPK:TKPYY) for exclusive development and commercialization outside of the US.
- Now read: TiGenix (TIG) Presents At Bank of America Merrill Lynch (NYSE:BAC) 2017 Health Care Conference - Slideshow
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