Friday, May 12, 2023 1:07:46 PM
The PR was very clear in stating DOOR is not an endpoint to be used in approvals. Further, it was about the previous trial data, and not the current trial that will determine if Sulopenam gets approved.
The point of the PR has to do with commercial value, not approvability. For antibiotics such as this, once approved it is still a marketplace battle. The PR is laying claim to marketplace value.
IMO, probably not going to be a blockbuster. But still will bring in solid cash if approved. And odds look decent.
Real issue here for investors is that they have over a year to go with the only possible news being a financing.
Recent ITRM News
- 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
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- Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/28/2024 11:00:00 AM
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- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 01:16:14 PM
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- 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
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