Initiate a registrational trial for OTL-203
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
- 11 Jan 2021
- Due
- 31 Dec 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Initiate a registrational trial for OTL-203 by year-end 2021.”
What we found
Evidence strength A What the grades mean
The company failed to initiate the registrational trial for OTL-203 by the end of 2021, subsequently pushing the target for regulatory clearance and trial initiation to later dates in 2022 and 2023.
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A Orchard Therapeutics plc 10-K filed 2023-03-14
“In December 2022 we received IND clearance of OTL-203 from the FDA, which allows us to initiate a global registrational study in MPS-IH. We plan to initiate the study... in the second half of 2023.” ✓ confirmed on the page
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A Orchard Therapeutics plc 8-K filed 2022-01-10
“OTL-203 for MPS-IH: Obtain the necessary regulatory clearance in mid-2022 to enable the initiation of the OTL-203 global registrational study in MPS-IH by year end.” ✓ 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
- Clinical milestone
- Indicative materiality
- Medium rules
- Action
- Initiate
- Deliverable
- OTL-203 registrational trial
- In the company’s control
- High
- Specificity
- High
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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