Friday, November 04, 2022 9:54:57 PM
"If the resubmission addresses all deficiencies in the complete response letter received in July 2021 from the FDA, then the FDA’s review and action will occur six months from receipt of the resubmission...."
"Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications including uUTI."
One of the Big Pharma companies could make a contingency partnership, but wondering why it takes so long to recruit patients?
If successful ka-ching, ka-ching in late 2024.
Recent ITRM News
- Form 8-K - Current report • Edgar (US Regulatory) • 10/15/2024 12:00:08 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 10/11/2024 08:01:41 PM
- Iterum Therapeutics to Present Data at IDWeek 2024 • GlobeNewswire Inc. • 10/10/2024 12:30:00 PM
- Iterum Therapeutics to Participate at the 2024 Maxim Healthcare Virtual Summit • GlobeNewswire Inc. • 10/09/2024 09:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/08/2024 01:15:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/04/2024 09:20:07 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/30/2024 08:15:02 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/30/2024 11:30:02 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/24/2024 01:01:07 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/24/2024 12:59:25 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/23/2024 10:30:01 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/11/2024 08:50:02 PM
- Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women • GlobeNewswire Inc. • 09/10/2024 11:00:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/09/2024 10:15:02 AM
- Iterum Therapeutics to Present at the 26th Annual H.C. Wainwright Global Investment Conference • GlobeNewswire Inc. • 09/06/2024 08:30:00 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/14/2024 08:15:03 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 11:30:26 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 11:15:36 AM
- Iterum Therapeutics Reports Second Quarter 2024 Financial Results • GlobeNewswire Inc. • 08/14/2024 11:00:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/14/2024 04:15:16 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 08/09/2024 09:28:56 PM
- Iterum Therapeutics to Report Second Quarter 2024 Financial Results on August 14, 2024 • GlobeNewswire Inc. • 08/07/2024 08:30:00 PM
- Iterum Therapeutics Announces Expiration and Results of Rights Offering • GlobeNewswire Inc. • 08/06/2024 09:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 09:25:18 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 08/02/2024 08:30:02 PM
SANUWAVE Announces Reverse Stock Split, Note and Warrant Exchange, and PIPE Offering • SNWV • Oct 18, 2024 9:31 AM
Vocodia Addresses Recent Stock Price Movement and Future Strategic Partnerships • VHAI • Oct 18, 2024 9:00 AM
Mass Megawatts Announces the Start of an Online Discount Solar Energy Equipment Business with Revenue Recognized for the First Time Since Year 2010 in this Fiscal Quarter • MMMW • Oct 18, 2024 7:32 AM
Unitronix Corp Advances DeFi Innovation with Tokenized Real-World Assets Integration • UTRX • Oct 17, 2024 7:38 AM
Mass Megawatts Commences Solar Energy Sales Efforts • MMMW • Oct 16, 2024 7:45 AM
SANUWAVE Health Announces 1-For-375 Reverse Stock Split • SNWV • Oct 16, 2024 7:40 AM