Provenance Record

Well-structured News piece (587 words) using the house Overview / What We Know / What We Don't Know / Analysis format. Clear separation of reported fact from interpretation. Technical depth is appropriate for a regulatory-approval story; the CAR-T comparison in the Analysis section is a fair, non-overstated framing.

All 3 source snapshots fetched at status 200 and read from disk (no re-WebFetch needed). source-0.html.gz (Orca Bio press release via BioSpace, biospace.com) — CONFIRMS: FDA approval July 1 2026; the verbatim indication quote ('for use in matched-donor... in the treatment of adults with hematological malignancies'); Precision-T Phase 3 n=187; primary endpoint cGFS at 12 months; 78% vs 38% cGFS; chronic GVHD 13% vs 44%; OS 94% vs 83%; NRM 3% vs 13%; Tregzi + single-agent tacrolimus vs alloHSCT + TAC/MTX. source-1.html.gz (BioSpace, 'Orca opens up Treg cell therapy...', biospace.com) — CONFIRMS: the 'first approval of a cell therapy using regulatory T cells' superlative (attributed by the source to the biotech); Orca-T clinical name; the four cancers (AML, ALL, MDS, MPAL); Karim Mikhail as acting director of FDA's CBER; Fernhoff 'marks a defining moment for Orca Bio and for the future of allogeneic transplant'; Negrin; 78% vs 38.4% cGFS; OS 94% vs 83%. source-2.html.gz (STAT, statnews.com) — CONFIRMS the Fernhoff interview quote verbatim ('Historically, the choice for a stem cell transplant carried a trade-off... improve survival free from graft-versus-host disease'). The STAT page is a STAT+ paywalled article; the snapshot captured the lead plus the pull quote, which is sufficient to verify the attributed quote. The only dollar figures in the STAT snapshot are STAT's own subscription prices; no drug price appears.

Every hard figure, the approval date, the indication text, the trial design, and all four attributed quotes trace to the cited snapshots and are not overstated. The 'first Treg-based cell therapy' superlative is properly hedged ('according to the biotech' / attributed to BioSpace). The Journalist-flagged unverifiable $428,000 price figure was confirmed ABSENT from the body and does not appear in any snapshot — correctly dropped. One issue: the adverse-reactions list is presented inside quote marks but does not reproduce the source exactly (the source reads 'mucositis, diarrhea, rash, viral infections, infections pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections'; the article capitalizes the leading word, expands 'aGVHD' to 'acute GVHD', and omits 'infections pathogen unspecified'). The set of reactions is otherwise accurate; this is a quote-mark fidelity slip, handled via the corrections trail.

Substantively accurate, well-sourced regulatory-approval story with all central claims verified against the source snapshots. The single quote-fidelity slip in the adverse-reactions passage is honestly summarizable in one corrections note, so APPROVE_WITH_CORRECTIONS rather than REJECT. The article publishes with a public corrections trail.