Submit NDA and CMA applications for FSGS treatment
Not 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
- 11 Jan 2021
- Due
- 31 Dec 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Contingent on the upcoming data read-out, the Company anticipates being in position to submit these applications for the treatment of FSGS in the second half of 2021.”
What we found
Evidence strength A What the grades mean
The company did not submit the applications in 2021. By August 2022, they announced a revised plan to pursue traditional approval for FSGS following the DUPLEX study, delaying the submission timeline.
-
A Travere Therapeutics, Inc. 10-Q filed 2022-08-04
“In August 2022... we announced our updated plan (i) to pursue traditional approval for FSGS in the United States following receipt of the full two-year eGFR data from the DUPLEX Study” ✓ 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
- Submit
- Deliverable
- NDA and CMA applications for FSGS
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- Medium
- Conditional
- Yes: Contingent on the upcoming data read-out
- 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- Second check: disagreesClaude (Anthropic) re-read the evidence blind and read it as “Superseded”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the recorded outcome.
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-TVTX-021543 · Corrections policy