CTI BioPharmaMore Questions on Pacritinib from Euro Medicines Agency

CTI BioPharma Corp. (NASDAQ:CTIC) today announced that the Company has received a second round of questions related to the Day 180 List of Outstanding Issues, for the marketing authorization application (MAA) for pacritinib, from the European Medicines Agency (EMA). The Company plans to submit responses to the EMA, which will include data from the ongoing open label PAC203 trial, by the end of the year. In addition, the Company is preparing for an Oral Explanation meeting before the Committee for Medicinal Products for Human Use (CHMP). A decision by CHMP on the MAA is expected in the first quarter of 2019.

https://www.biospace.com/article/releases/cti-biopharma-provides-program-update-following-regulatory-feedback-on-pacritinib-development-from-the-european-medicines-agency/