Submit a Biologics License Application for ABP 798 in the U.S
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
- 29 Oct 2019
- Due
- 31 Mar 2020
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Submission of a Biologics License Application in the U.S. for ABP 798 is expected in Q1 2020.”
What we found
Evidence strength A What the grades mean
Amgen's SEC filings confirm the FDA had already set a target action date for the ABP 798 BLA by April 2020, implying the submission occurred by the Q1 2020 deadline.
-
A Amgen Inc. 8-K filed 2020-04-30
“The FDA has set a Biosimilar User Fee Act target action date of Dec. 19, 2020 for the Biologics License Application for ABP 798” ✓ confirmed on the page
Market reaction: the shares moved +1.3% against the S&P 500 over the three sessions around the disclosure (29 Apr 2020 to 4 May 2020). What this measures
Checked 1 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
- Biologics License Application for ABP 798
- Where
- U.S.
- Language
- Expected (“expects”, “plans”)
- 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 agrees with the recorded outcome.
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-2019-AMGN-001679 · Corrections policy