![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Saturday, July 03, 2021 4:27:40 PM
I believe what's very clear is that the FDA will eventually approve the drug, whether this time is the charm or not, it will happen.
I've never liked the delays and costs imposed by the FDA, but I think it's clear that once the company agrees to their terms, it will be approved. Hopefully that's possible in the next few weeks.
I have seen many approvals delayed for products I was certain would be approved, not a single one failed to ultimately be approved. Sadly the FDA never seems to care how much their actions cost the drug developers in time and money, and more importantly how many patients have to suffer, and in some cases die, because the FDA is unwilling to be more flexible.
What would be the harm if the FDA said, approved, but it's conditional to making labeling or other changes. I believe the changes could easily be made knowing that when they were the product would immediately be on the market.
Gary
Recent ITRM News
- Iterum Therapeutics Announces FDA Advisory Committee Meeting to discuss NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections • GlobeNewswire Inc. • 06/21/2024 12:00:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 06/07/2024 08:11:36 PM
- Iterum Therapeutics to Present Data at ASM Microbe 2024 • GlobeNewswire Inc. • 06/05/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 12:30:12 PM
- Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections • GlobeNewswire Inc. • 05/31/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/13/2024 11:30:38 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 11:15:13 AM
- Iterum Therapeutics Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/13/2024 11:00:00 AM
- Iterum Therapeutics to Report First Quarter 2024 Financial Results on May 13, 2024 • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem • GlobeNewswire Inc. • 04/29/2024 12:00:00 PM
- US Stock Futures Stable in Pre-Market On Path for Consecutive Quarterly Gains, Oil Prices Rise • IH Market News • 03/28/2024 11:42:00 AM
- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/28/2024 11:00:00 AM
- Iterum Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024 • GlobeNewswire Inc. • 03/21/2024 08:30:00 PM
- Iterum Therapeutics to Participate in H.C. Wainwright Virtual @Home Fireside Chat • GlobeNewswire Inc. • 03/15/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 01:16:14 PM
- Iterum Therapeutics Provides Business Update • GlobeNewswire Inc. • 03/06/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 10:00:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 12:15:32 PM
- Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections • PR Newswire (US) • 01/30/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/29/2023 09:30:15 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 12/14/2023 12:45:02 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 12/14/2023 12:30:02 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 12/04/2023 10:15:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/04/2023 10:00:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/04/2023 01:30:09 PM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM