CTI BioPharma Provides Program Update Following Regulatory Feedback on Pacritinib Development from the European Medicines Agency
CTI BioPharma Corp. (CTIC)
Last cti biopharma corp. earnings: 11/1 08:00 am
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Source: PR Newswire
SEATTLE, Nov. 26, 2018 /PRNewswire/ -- 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.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding
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