Kaviaar schreef op 3 juli 2018 18:18:
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Kiadis Pharma on track with European regulatory review for ATIR101
Responses submitted to EMA
Day 120 list of questions
Amsterdam, The Netherlands, March 28, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) in hematopoietic stem cell transplantations (HSCT), today confirms it has submitted its responses to the European Medicines Agency’s (EMA) Day 120 List of Questions for its lead product candidate ATIR101 within the timeline that had been agreed with EMA
and announced in September 2017.
Arthur Lahr, CEO of Kiadis Pharma, commented: “We are pleased to have submitted our responses to EMA’s Day 120 List of Questions in a timely manner. We believe we have adequately addressed the questions and remain on track to potentially obtain a positive CHMP opinion for ATIR101 in Q4 2018 and (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019.
www.kiadis.com/kiadis-pharma-on-track...