Complete modular PMA submission for Galleri
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
- 20 Feb 2025
- Due
- 30 Jun 2026
- Delivered
- January 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“complete our modular PMA submission in the first half of 2026.”
What we found
Evidence strength A What the grades mean
The company submitted its PMA application to the FDA in January 2026, which occurred before the first half of 2026 deadline.
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A Grail, Inc. 10-K filed 2026-03-12
“In January 2026, we submitted a PMA to the FDA to help support broad access for Galleri in the United States.” ✓ 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 lineage
Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.
- Deadline drift -91 days
- 2 versions
-
Version 1 · original · stated 20 Feb 2025
Deadline 30 Jun 2026 (“in the first half of 2026”)
-
Version 2 · stated 12 Nov 2025
Deadline 31 Mar 2026 (“in the first quarter of 2026”) · wording expected
“we anticipate completing our PMA submission for Galleri to the FDA in the first quarter of 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
- Modular PMA submission
- 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-003109 · Corrections policy