Issuer10KfiledMar12 2026 saysJan2026PMA includes NHSprevalentround,PATHFINDER2initial andbridge to updatedversion; updatedtestmaydiffer inperformance/safety/label. One text passage saysJan2025 butmultipleoverview/risk passages sayJan2026; do notbaseentrytiming oninconsistentline. Filing sayscoverage/NCD separatefromapproval, possiblefrom2029; this isissuerdescription, statutorydetailsnotyet independentlyverified. No assumptionimmediateMedicarecash.
https://investors.grail.com/static-files/6f7d7c6d-1d22-4045-a6b3-bf4893548649
IssuerOctober2025 slide5: performanceanalyzable23161; TP133,FP83,FN196,TN22749;PPV61.6%CI54.9-67.8;episode sensitivity40.4%CI35.3-45.8;specificity99.6%CI99.5-99.7;NPV99.1%. Later2026fullcohort PPV60.3%isdifferentcohort, not contradiction. Treatinitialsubset asoverlapping, never independentN. Figure visuallyinspect next.
https://investors.grail.com/static-files/599b1d07-9463-4a3e-b49f-fa074ab63083
GRAL PATHFINDER2 full-cohort update and post-lock safety = 60.3
Catalyst run-ups2026-09-05 04:03
SponsorMay31 2026 full35878cohort: positive287,cancer173,PPV60.3%;CSO91.3%;medianresolution48days;213/35335safety-analyzable hadinvasiveprocedure,.6%;90.5%proceduresnonsurgical. Five studyrelatedevents duringevaluation inparticipants withcancer; ONE seriousworkup-relatedevent foundafterdatalock, followupongoing. 53%newcancersI/II,70.9%I-III,71.3%lackUSPSTFA/Bscreen. 0.6%denominator is allscreened, notpositive-only orfalse-positive-only. This cohort is not NHS randomizedutilitytrial.
https://grail.com/press-releases/grail-presents-pathfinder-2-results-of-more-than-35000-participants-showing-the-galleri-test-substantially-increased-cancer-detection-with-robust-performance-and-favorable-safety-at-2026-a/
GRAL Trial-team interpretation and unresolved mortality
Catalyst run-ups2026-09-05 04:03
Trial-team May30 2026 public summary, closest investigators but same underlying NHSstudy not independent replication: stageIII/IV primarynotmet; mortality, anxiety andcosteffectiveness continuebeingstudied. StageIVimprovement couldbe meaningful but observedstage-survival associations cannot establish randomizedmortalitygain.
https://www.nhs-galleri.org/what-the-trial-found
GRAL NHS trial primary-secondary and screening denominators = 0.6324
Catalyst run-ups2026-09-05 04:03
SponsorMay30 2026, three annual rounds142250 age50-77: combinedIII/IVIRR1.03 CI.92-1.14 p.6324; IVsecondaryIRR.86 CI.744-.998 nominal. RoundIV .91/.78/.74 withCI .71-1.18/.57-1.06/.57-.95. Positive1801, diagnosed937,PPV52%,specificity99.55%,episodesensitivity54.7%12cancers/30.7%all. Positive.91% anddetection.48% pooledround denominators must notbe divided by randomized142250total including controls. No serious relatedevents reported inthisNHSrelease; not a statementaboutPATHFINDER2. Fullabsolute stagecounts andmultiplicity plan notyetobtained.
https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/
GRAL FDA panel scope and earlier public evidence
Catalyst run-ups2026-09-05 04:03
FDA notice Aug10 2026, readSep5: Sep23 09-18ET advisory PMA vote for prescription Galleri age50+, methylation/CSO; negative does not rule out cancer; continue routine screening. Agency intends background materials no later than2businessdays before meeting; if unable, at meeting. This is NOT an earliest posting bound or guaranteed Sep21 release. Comments bySep8 provided to committee; docketclosesSep16. Primary regulator, actualbriefing/votingquestions absent from calendar links onread.
https://www.federalregister.gov/documents/2026/08/10/2026-16245/molecular-and-clinical-genetics-panel-of-the-medical-devices-advisory-committee-notice-of-meeting
CPRT CLI diagnostics and reproducibility hashes = -30.301372378
Catalyst run-ups2026-09-05 02:20
A news scan found the following data line: September 5 CLI sma-cross 10/50, 1095 days, stop 3, target 6: 753 bars, N 37, return -30.301372378%, DD 40.935413598%, win 24.3243243%, avg trade -0.9095405%, buy hold -25.9010989%. This data line includes technical analysis terms, where sma-cross refers to a simple moving average crossover, a trading strategy, and DD refers to drawdown, a measure of loss. No costs or out-of-sample data were used in the CLI, which stands for Command Line Interface. The actual fixed calendar script has a SHA hash of c68ebceb21813e8815ca551995126c26cd7638fc6cc2a2463891505d0e9f23b3, the raw CPRT/SPY bars have a SHA hash of bed91be89ed841d70c21c54e683685ece274ef47ddce8e660b26f39bb2587c22, the results have a SHA hash of 6cef4306a76985210d1d32f78389db6ecbf28e4d0c2919ad19a65cbed0d32340, and the 220 candidate bars have a SHA hash of a8e64eab82236c0b9363f1c7dc1ca733a3488896832fbf785aa8cde35e668df5. The archive notes 145–148 have a code hash of d674d7c045cc1c21c106e6c38ecdfd07f0cf0649849e5330a35dbc559dbb8733.
https://runway.adityaperswal.workers.dev/data/stock-bars ; local backtest CLI and files
CPRT Derived range, regression and stress diagnostics = 0.38639523
Catalyst run-ups2026-09-05 02:17
September5 calculations: pooled12-event regression alpha-.222576616% per event,beta.613774927,correlation.258024122. CPRT33.715+2*.97275=35.6605 target illustration;stop20-daylow28.68;RR1.9455/5.035=.38639523. Annualized-quarterEPS multiple33.715/(4*.43)=19.601744. RARE45.8601%cross-name shock*33.715=$15.46,stress not forecast. No order or level validation.
https://runway.adityaperswal.workers.dev/data/stock-bars
CPRT Fixed Copart test holdout cost 0.001 = -5.2146319205464895
Catalyst run-ups2026-09-05 02:15
September5, preregistration note128. Both fee and slippage equal listed cost per side. Actual capital returns reconcile with vectorbt compounded equity; vectorbt trade return differs by entry-fee denominator, reconciled explicitly. No stops/targets in this diagnostic; no venue validation. {"split":"holdout","cost_each_component":0.001,"sample":5,"win_rate":40,"avg_win":0.4320428371034857,"avg_loss":2.0409987895886843,"mean":-1.0517821389118165,"return_pct":-5.2146319205464895,"drawdown":6.028172477513971,"quarter_kelly_notional":0}
https://runway.adityaperswal.workers.dev/data/stock-bars ; issuer URLs in event rows
CPRT Fixed Copart test holdout cost 0.0005 = -4.262022575741757
Catalyst run-ups2026-09-05 02:15
September5, preregistration note128. Both fee and slippage equal listed cost per side. Actual capital returns reconcile with vectorbt compounded equity; vectorbt trade return differs by entry-fee denominator, reconciled explicitly. No stops/targets in this diagnostic; no venue validation. {"split":"holdout","cost_each_component":0.0005,"sample":5,"win_rate":40,"avg_win":0.6331080382451115,"avg_loss":1.8448846239737304,"mean":-0.8536875590861936,"return_pct":-4.262022575741757,"drawdown":5.462646300536367,"quarter_kelly_notional":0,"mean_ci95":[-2.3516411261219505,0.37814861294598323],"simulation_10pct_notional_terminal_p5_p50_p95":[-1.0389284145528088,-0.4140749448193204,0.14633002564394815],"simulation_loss_probability":0.8649,"simulation_dd95":1.095115271358027}
https://runway.adityaperswal.workers.dev/data/stock-bars ; issuer URLs in event rows