Submit a supplemental Biologics License Application for Trodelvy
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
- 14 Sep 2020
- Due
- 31 Dec 2020
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States in the fourth quarter of 2020.”
What we found
Evidence strength A What the grades mean
Gilead's SEC filings confirm the submission of the supplemental Biologics License Application for Trodelvy, which subsequently received full FDA approval in April 2021.
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A Gilead Sciences Inc. 10-K filed 2021-02-25
“We submitted a supplemental Biologics License Application (“sBLA”) to FDA for approval of Trodelvy as a treatment for adult patients with mTNBC” ✓ confirmed on the page
Market reaction: the shares moved -1.4% against the S&P 500 over the three sessions around the disclosure (24 Feb 2021 to 1 Mar 2021). 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
- Supplemental Biologics License Application
- Where
- United States
- 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 “no_evidence”.
- 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-2020-GILD-003181 · Corrections policy