Horizon Therapeutics Public Ltd Co
Submit data from the first increased scale TEPEZZA manufacturing lot to the FDA
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
- 11 Jan 2021
- Due
- 31 Jan 2021
- Delivered
- 25 Jan 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“we are on track to submit the resultant data to the FDA by the end of this month.”
What we found
Evidence strength A What the grades mean
Horizon Therapeutics submitted a prior approval supplement to the FDA in January 2021, which included the required data to support increased scale production of TEPEZZA.
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A Horizon Therapeutics Public Ltd Co 8-K filed 2021-02-01
“Last week, Horizon submitted a prior approval supplement to the U.S. Food and Drug Administration (FDA) to support increased scale production of TEPEZZA drug product for the treatment of Thyroid Eye Disease (TED).” ✓ confirmed on the page
Checked 24 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Clinical readout
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- TEPEZZA manufacturing data
- Language
- Firm (“will”, “on track to”)
- In the company’s control
- High
- Specificity
- High
- 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.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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