ITRM after hours news. FDA says approval next. Continuing tomorrow, Boom
ITRM >DUBLIN, Ireland and CHICAGO, May 27, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company participated in a late-cycle meeting with the U.S. Food and Drug Administration (“FDA”) yesterday. During the meeting, the FDA shared issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and the Company responded to these issues.******** The FDA has determined that an Advisory Committee meeting is not currently necessary. The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021.********
