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

CTI Biopharma

29/09/2020 21:24

Sept 29 (Reuters) - CTI Biopharma Corp  CTIC.O :
    * 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

Source text for Eikon:  ID:nPn8JvCN3a 
Further company coverage:  CTIC.O 

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