Complete the rolling submission for lecanemab under the accelerated approval pathway
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
- 3 May 2022
- Due
- 30 Jun 2022
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Biogen and Eisai plan to complete the rolling submission for lecanemab under the accelerated approval pathway in the U.S. in the second quarter of 2022.”
What we found
Evidence strength A What the grades mean
Later 10-Q filings state Eisai completed the BLA submission for accelerated approval in May 2022, before the June 30 deadline. One filing says July 2022, a conflict.
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A Biogen 10-Q filed 2022-07-20
“In May 2022 Eisai completed the submission of a Biologics License Application (BLA) to the FDA for the accelerated approval of lecanemab.” ✓ confirmed on the page
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A Biogen 10-Q filed 2022-07-20
“In May 2022 we and our collaboration partner Eisai announced the completed submission of a Biologics License Application (BLA) to the FDA for the accelerated approval of lecanemab” ✓ confirmed on the page
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A Biogen 10-Q filed 2022-07-20
“In July 2022 Eisai completed the submission of a BLA to the FDA for the accelerated approval of lecanemab.” ✓ confirmed on the page
Market reaction: the shares moved -7.1% against the S&P 500 over the three sessions around the disclosure (19 Jul 2022 to 22 Jul 2022). What this measures
Checked 10 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 other
- Indicative materiality
- Medium rules
- Action
- Complete
- Deliverable
- lecanemab rolling submission
- Where
- U.S.
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Partner
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.
- Second check: agreesA different AI model, Gemini (Google), 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-2022-BIIB-005345 · Corrections policy