Submit a New Drug Application to the FDA for AGN-190584
Delivered by 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
- 30 Oct 2020
- Due
- 30 Jun 2021
- Delivered
- February 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Additional details from the GEMINI 1 and GEMINI 2 studies will be presented at future medical meetings and will serve as the basis for a New Drug Application (NDA) submission to the FDA in the”
What we found
Evidence strength A What the grades mean
AbbVie submitted the New Drug Application for AGN-190584 to the FDA in February 2021, which is within the first half of 2021 deadline.
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A AbbVie Inc. 10-Q filed 2021-08-02
“In February 2021, AbbVie submitted an NDA to the FDA for investigational AGN-190584 for the treatment of presbyopia.” ✓ confirmed on the page
Market reaction: the shares moved -1.2% against the S&P 500 over the three sessions around the disclosure (30 Jul 2021 to 4 Aug 2021). What this measures
Checked 2 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
- New Drug Application for AGN-190584
- Language
- Firm (“will”, “on track to”)
- 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, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- 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-2020-ABBV-003845 · Corrections policy