Iterum Therapeutics (ITRM)

[Here Today]

Just basing it on the 8K and PR which states that before the FDA can begin discussing the Labeling and Marketing, they need to clear up the deficiencies that were discovered. No Where does it state that the deficiencies has anything to do with labeling!!! That’s basic English language READING COMPREHENSION:


“On July 1, 2021, Iterum Therapeutics plc (the “Company”) issued a press release announcing that it had received a letter from the U.S. Food and Drug Administration (“FDA”) stating that, as part of their ongoing review of the Company’s New Drug Application for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that PRECLUDE the continuation of the discussion of labeling and post marketing requirements/commitments at this time.”