Launch oral sulopenem in the U.S
Not delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 1 Feb 2021
- Due
- 31 Dec 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“We will be working diligently to ensure we are ready for the potential launch of oral sulopenem in the U.S. in the fourth quarter of 2021.”
What we found
Evidence strength A What the grades mean
The company did not launch oral sulopenem in 2021 because it received a Complete Response Letter from the FDA in July 2021, which required additional clinical trials before approval could be granted.
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A Iterum Therapeutics plc 10-Q filed 2022-05-13
“We received a CRL from the FDA on July 23, 2021 in respect of our NDA. The CRL provided that additional data are necessary to support approval of oral sulopenem” ✓ confirmed on the page
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A Iterum Therapeutics plc 10-Q filed 2022-05-13
“Following receipt of the CRL in the third quarter of 2021, in order to reduce operating expenses and conserve cash resources, we halted any remaining pre-commercial activities for oral sulopenem” ✓ confirmed on the page
Checked 25 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Commercial launch
- Indicative materiality
- Medium rules
- Action
- Launch
- Deliverable
- oral sulopenem
- Where
- U.S.
- Language
- Firm (“will”, “on track to”)
- In the company’s control
- Medium
- Specificity
- Medium
- Conditional
- Yes: potential launch
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
- Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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