File an MAA for OTL-103 in the EU
Not delivered by the deadline
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- Announced
- 11 Jan 2021
- Due
- 31 Dec 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“File an MAA for OTL-103 in the EU by year-end 2021.”
What we found
Evidence strength A What the grades mean
The company failed to file the MAA by the year-end 2021 deadline, subsequently announcing in January 2022 that it was preparing for a submission in mid-2022.
-
A Orchard Therapeutics plc 8-K filed 2022-01-10
“Orchard is preparing for a Marketing Authorization Application (MAA) submission for OTL-103 in Europe in mid-2022.” ✓ 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
- Regulatory submission
- Indicative materiality
- High rules
- Action
- File
- Deliverable
- MAA for OTL-103
- Where
- EU
- 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.
- 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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