Item 8.01. Other Events.
On May 27, 2021, Iterum Therapeutics plc (the "Company") issued a press release
announcing that on May 26, 2021 the Company participated in a late-cycle meeting
with the U.S. Food and Drug Administration ("FDA") during which, the FDA shared,
and the Company responded to, 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. 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
The full text of the press release issued in connection with this announcement
is attached as Exhibit 99.1 to this Current Report of Form 8-K and incorporated
herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press Release of Iterum Therapeutics plc dated May 27, 2021
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