Sjonnie2 schreef op 31 augustus 2018 09:31:
@Ronn. Hier is het antwoord op je eerste vraag, dit staat trouwens ook onderaan het persbericht van de halfjaarcijfers op de Kiadis website.
De EMA procedure heb ik als bijlage nog maar weer eens bijgevoegd.
Ps: Sanderus zijn verhaal is juist.
About Kiadis Pharma
Kiadis Pharma is initially developing its lead product candidate, ATIR101, for use in conjunction with haploidentical HSCT for adult blood cancers to address key limitations of haploidentical HSCT, without prophylactic immunosuppression and its associated morbidity and mortality. Based on the positive results from the single dose Phase II CR-AIR-007 study, the Company submitted a marketing authorization application, or MAA,
to the European Medicines Agency, or EMA, in April 2017 for approval of ATIR101 as an adjunctive treatment in haploidentical HSCT for high risk adult hematological malignancies. Kiadis Pharma submitted responses to the EMA’s Day 180 List of Issues in August 2018. The Company expects a Committee for Medicinal Products for Human Use, or CHMP, opinion in the fourth quarter of 2018 which, if positive, would enable it to receive a conditional marketing approval from the European Commission as early as in the first quarter of 2019. If then conditionally approved, Kiadis Pharma intends to launch ATIR101 in selected countries in Europe through its own commercial organization starting in the second half of 2019.