Koro schreef op 17 oktober 2019 17:54:
Kiadis Pharma provides regulatory update on ATIR101
Kiadis no longer expects EU conditional marketing authorization for ATIR101 in 2020
Kiadis plans to refile at the conclusion of the ongoing phase 3 trial
Amsterdam, The Netherlands, 17 October 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it no longer expects to receive EU conditional marketing authorization for ATIR101 in 2020. The Company expects that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) will issue a negative opinion and recommend against conditional marketing authorization at the next CHMP meeting in November 2019.
Kiadis Contacts: