Submit a biologics license application for donanemab
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
- 3 Aug 2021
- Due
- 31 Dec 2021
- Delivered
- by 31 Dec 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer's disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year”
What we found
Evidence strength A What the grades mean
The company initiated a rolling submission for donanemab in the U.S. during 2021, fulfilling the commitment to submit the application by the end of that year.
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A ELI Lilly & Co 10-K filed 2022-02-23
“We have commenced a rolling submission in the U.S. for donanemab for the treatment of Alzheimer's disease.” ✓ confirmed on the page
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A ELI Lilly & Co 10-Q filed 2022-04-29
“Initiated a rolling submission in the U.S. for accelerated approval in 2021.” ✓ confirmed on the page
Market reaction: the shares moved -0.4% against the S&P 500 over the three sessions around the disclosure (28 Apr 2022 to 3 May 2022). 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
- donanemab biologics license application
- 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: disagreesClaude (Anthropic) re-read the evidence blind and read it as “Not met”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and reads it as “no_evidence”.
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-LLY-004214 · Corrections policy