Submit data from the prevalent screening round of the NHS-Galleri trial for premarket approval
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
- 13 May 2025
- Due
- 30 Jun 2026
- Delivered
- January 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“GRAIL plans to submit data from the prevalent screening round of the NHS-Galleri trial as part of our premarket approval application in the first half of 2026.”
What we found
Evidence strength A What the grades mean
Grail submitted its premarket approval application to the FDA in January 2026, which included the required data from the prevalent screening round of the NHS-Galleri trial.
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A Grail, Inc. 10-K filed 2026-03-12
“in January 2026, we submitted a PMA to the FDA including the full prevalent screening round analysis from the NHS-Galleri Trial” ✓ confirmed on the page
Market reaction: the shares moved -0.2% against the S&P 500 over the three sessions around the disclosure (11 Mar 2026 to 16 Mar 2026). 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
- Clinical readout
- Indicative materiality
- Medium rules
- Action
- Submit
- Deliverable
- NHS-Galleri prevalent screening round data submission
- 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: 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-2025-GRAL-003112 · Corrections policy