CTI BioPharma Corp

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Products, Regulatory

CTI Biopharma To Submit A New Drug Application For The Accelerated Approval Of Pacritinib

Published: 09/29/2020 20:30 GMT
CTI BioPharma Corp (CTIC) - Cti Biopharma to Submit a New Drug Application (nda) for the Accelerated Approval of Pacritinib for the Treatment of Myelofibrosis Patients With Severe Thrombocytopenia.
Cti Biopharma Corp - Rolling NDA Expected to Commence in Q4 of 2020.
Cti Biopharma Corp - Company to Proceed With Rolling NDA Submission Following Recent Pre-nda Meeting With FDA.
Cti Biopharma Corp - Completion of NDA Submission Expected in Q1 2021.
Cti Biopharma Corp - Ongoing Phase 3 Pacifica Trial is Expected to Be Completed As a Post-marketing Commitment.
Cti Biopharma - NDA Will Be Based on Available Data From Co's Completed Phase 3 Persist-1 and Persist-2 Trials, Phase 2 Pac203 Dose-ranging Trial.