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Acer Therapeutics Inc.

Submit the NDA for ACER-001 for UCDs

Delivered after 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
15 Jan 2021
Due
30 Jun 2021
Delivered
August 2021
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“ACER-001 (UCDs) NDA submission*$: Mid-2021”

What we found

Evidence strength A What the grades mean

The company committed to a mid-2021 NDA submission, but filings confirm the submission occurred in August 2021, which is after the June 30, 2021 deadline.

  • A
    Acer Therapeutics Inc. 8-K filed 2021-08-10 Regulatory filing · published 10 Aug 2021 · retrieved 24 Oct 2026 · kept permanently by the SEC · fingerprint 1cc27dfab464
    “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 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 submission
Indicative materiality
High rules
Action
Submit
Deliverable
ACER-001 NDA submission
In the company’s control
Medium
Specificity
High
Conditional
Yes: Assuming successful outcomes of BE trial under fed conditions; additional nonclinical work; long-term stability data; Subject to additional capital
Depends on
Regulatory

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
  3. Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.

Confirmed. This outcome counts towards the company's Kept Score. How verification works

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Report an error in this entry Reference: KI-C-2021-C069308-022134 · Corrections policy

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