Complete analysis of the HOPE-B safety event and submit it to the FDA
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 1 Mar 2021
- Due
- 31 Mar 2021
- Delivered
- 26 Mar 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Analysis of the HOPE-B safety event expected to be completed and submitted to the FDA before end of the first quarter of 2021”
What we found
Evidence strength A What the grades mean
Later filings state the HOPE-B HCC investigation results were submitted to the FDA on March 26, 2021, before the March 31, 2021 deadline.
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A uniQure N.V. 8-K filed 2021-04-01
“Data from investigation submitted to U.S Food and Drug Administration (FDA) on March 26, 2021” ✓ confirmed on the page
-
A uniQure N.V. 10-Q filed 2021-05-10
“On March 26, 2021, we submitted the results of a comprehensive investigation into the case of HCC to the FDA.” ✓ confirmed on the page
Checked 26 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
- HOPE-B safety event analysis submitted to FDA
- Language
- Aspirational (“aims”, “intends”)
- 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, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-QURE-024797 · Corrections policy