The FDA's letter didn't "reflect a final decision on the information under review," according to Iterum. But it seems a foregone conclusion that any potential approval for sulopenem etzadroxil/probenecid will be later than expected.
In May, Iterum met with the FDA, and the agency shared some issues that were still under review at that time. The company said that it had responded to those issues, and that the FDA decided not to convene an advisory committee meeting to review the application for approval of sulopenem etzadroxil/probenecid.
Now what
Iterum now plans to work with the FDA to learn more about the deficiencies mentioned in the agency's letter. CEO Corey Fishman said that his company will "resolve the issues as expeditiously as possible in order to continue advancing this much needed antibiotic."