Complete interactions with the FDA regarding the OTL-200 BLA filing path
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
- 30 Jun 2021
- Delivered
- June 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“By mid-2021, complete interactions with the U.S. Food and Drug Administration (FDA) to determine the path to a BLA filing for OTL-200.”
What we found
Evidence strength A What the grades mean
Orchard Therapeutics confirmed in June 2021 that it held a productive meeting with the FDA and received written feedback regarding the clinical package required for the OTL-200 BLA filing.
-
A Orchard Therapeutics plc 8-K filed 2021-08-04
“In June 2021, Orchard announced several portfolio updates following recent regulatory interactions... Orchard held a productive meeting with the U.S. Food and Drug Administration (FDA) and has received written feedback concerning the clinical package expected to support a Biologics License Applicati” ✓ 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
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Complete
- Deliverable
- FDA interactions for OTL-200
- Where
- U.S.
- In the company’s control
- Medium
- 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: disagreesClaude (Anthropic) re-read the evidence blind and read it as “Not met”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the recorded outcome.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
Are you Orchard Therapeutics plc? You can publish an official statement next to this entry, free. Add a statement.
Is something here wrong or out of date? Companies and readers can ask us to check it. Please bring a link to a public source.
Report an error in this entry Reference: KI-C-2021-C748907-021796 · Corrections policy