Provide complete response to FDA requests on VY-HTT01 IND application
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
- 25 Feb 2021
- Due
- 30 Jun 2021
- Delivered
- Q1 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Voyager plans to provide its complete response to the FDA in the first half of 2021”
What we found
Evidence strength A What the grades mean
Later 10-Q and 10-K filings state the company provided its complete response to FDA requests on the VY-HTT01 IND in Q1 2021, before the June 2021 deadline. Later decisions to not start the trial are separate.
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A Voyager Therapeutics, Inc. 10-Q filed 2021-08-09
“We provided a complete response to the additional requests from the FDA regarding the IND application for VY-HTT01 in the first quarter of 2021, and the FDA removed its clinical hold on the IND” ✓ confirmed on the page
-
A Voyager Therapeutics, Inc. 10-K filed 2022-03-08
“We provided a complete response to the additional requests from the FDA regarding the IND application for VY-HTT01 in the first quarter of 2021” ✓ 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
- Provide
- Deliverable
- Complete response to FDA on VY-HTT01 IND application
- Language
- Expected (“expects”, “plans”)
- 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, 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-VYGR-024610 · Corrections policy