Iterum Therapeutics plc announced that it received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021. The CRL provided that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form. In the CRL, the FDA acknowledged that the Phase 3 SURE-1 clinical trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population. However, the FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone. The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug. Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation does not raise an approvability issue. The FDA indicated its willingness to work with Iterum on the design of the clinical trial to address the deficiencies noted. There were no chemistry, manufacturing or controls (CMC) issues identified in the CRL, nor were there any safety issues found in over 1,800 patients treated with sulopenem across the Company’s clinical development program. Iterum intends to review the CRL with its advisors and plans to request a Type A meeting in the coming weeks. Following the Type A meeting, anticipated to be late in the third quarter, Iterum expects to provide an update on next steps as to the potential additional clinical and non-clinical work to be done prior to a resubmission of the NDA for approval of oral sulopenem. Iterum notes that cash, cash equivalents and short-term investments were $100.5 million at the end of the first quarter of 2021. Based on the current operating plan and subject to final determination of the design and planned conduct of additional clinical and potential nonclinical development for sulopenem, the Company believes that it is well positioned financially to fund its operations into the second half of 2023.