Submit a New Drug Application for ACER-001 for urea cycle disorders
Delivered after 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
- 30 Jun 2021
- Delivered
- August 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Mid-2021: ACER-001 NDA submission for treatment of patients with Urea Cycle Disorders (UCDs) is anticipated in mid-2021, provided that no additional data is requested by the FDA”
What we found
Evidence strength A What the grades mean
The NDA for ACER-001 was submitted in August 2021, after the mid-2021 (June 30, 2021) target. An 8-K filed 2021-08-09 also reports the submission.
-
A Acer Therapeutics Inc. 8-K filed 2021-08-09
“With the NDA now submitted, we will continue our efforts to back ACER-001’s development in Europe” ✓ confirmed on the page
-
A Acer Therapeutics Inc. 8-K filed 2021-08-10
“submitted a New Drug Application (NDA) in August 2021 for ACER-001 for the treatment of Urea Cycle Disorders (UCDs)” ✓ 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 submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- ACER-001 NDA submission for urea cycle disorders
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- Medium
- Conditional
- Yes: provided that no additional data is requested by the FDA during the pre-NDA meeting; ongoing development activities are successfully completed, including evaluation of long-term product stability data
- 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
Are you Acer Therapeutics Inc.? 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Is something here wrong or out of date?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-C069308-024921 · Corrections policy