{ "schema_version": 1, "checked_at_utc": "2026-09-11T03:38:57.932104+00:00", "review_type": "AI-assisted second review of retained packet integrity and targeted source interpretation; not independent human adjudication", "canonical_inventory": { "candidate_packets_sha256": "8cf99b8f0669aa2ebea0a39dc71bfaf373940592148c42fba2b0828985191e0d", "last_retained_production_readback_date": "2026-09-10", "fresh_private_queue_query_performed": false, "warning": "Readiness counts describe the retained 27-case inventory, not a new live ledger query or the full catalogue." }, "readiness": { "total_cases": 27, "awaiting_independent_human_approval": 25, "needs_further_evidence": 2, "human_approvals_performed_in_this_work": 0, "approved_cases_in_retained_inventory": 0, "automated_integrity_recheck": { "matching_retained_production_readbacks": 27, "source_archives_sha256_verified": 38, "json_anchor_checks": 205, "pdf_anchor_metadata_checks": 45, "selected_registry_arm_labels_checked": 37 }, "accuracy_estimate": null, "accuracy_not_available_reason": "No independent human labels or held-out accuracy adjudication were obtained. Digest/anchor/arm-label checks validate preservation and referential consistency, not clinical correctness." }, "adheroza_recheck": { "din": "02550989", "product": "ADHEROZA", "presentation": "TRASTUZUMAB 420 MG / VIAL; Canadian kit with vial and supplied diluent", "cases": [ "pf-103974-02550989-NCT02581748", "pf-103974-02550989-NCT03084237" ], "disposition": "needs_further_evidence; unchanged", "findings": [ { "finding_id": "canadian_presentation", "status": "source_supported", "observation": "The Canadian monograph distinguishes a 150 mg single-use vial from a 420 mg multidose vial packaged with 20 mL bacteriostatic water containing 1.1% benzyl alcohol. The kit descriptor and powder dosage form describe different aspects of the same presentation. This supports structured identity clarification, not trial linkage.", "source_url": "https://pdf.hres.ca/dpd_pm/00084164.PDF", "source_sha256": "1d5379c0b8100c13bf5f58ed6e8f169e967df1fe4a231fd12e54b16a1c38fac7", "source_locator": "Physical PDF pages 11-12 and 15-16", "evidence_access": "Retained body checksum verified; text inspected. Live web fetch unavailable this pass." }, { "finding_id": "official_study_mentions", "status": "source_supported", "observation": "The Health Canada SBD lists DIN 02550989 and both marketed strengths, identifies Adheroza as HLX02, and discusses HLX02-HV01 Part 2 and HLX02-BC01. These are official submission/study references. The inspected manufacturing sections do not explicitly bind the 150 mg clinical vial to the Canadian 420 mg kit.", "source_url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736954230750", "source_sha256": "07d6629a87462fa1628cfb477a498751d5df32b862d8a154cac760444300de38", "source_locator": "/source_fields/15/text, /source_fields/48/text, /source_fields/123/text, /source_fields/132..143/text, /source_fields/159..160/text, /source_fields/162/text", "evidence_access": "Retained normalized body checksum and anchors verified; substantive fields read. Current web fetch returned 403." }, { "finding_id": "hv01_presentation", "status": "source_supported_different_presentation", "observation": "The EMA assessment explicitly identifies the HLX02 presentation in the HV01 study as a 150 mg vial reconstituted using sterile water without preservative; comparator vial information is separate. That is not direct evidence of Canadian 420 mg kit exposure.", "source_url": "https://www.ema.europa.eu/en/documents/assessment-report/zercepac-epar-public-assessment-report_en.pdf", "source_sha256": "c0ee3e92a79d3c7dfe012dd4d3384deb1d67770994d43a5f9d9645ece0dda29c", "source_locator": "Physical PDF page 47, Study HLX02-HV01 Part 2 / Figure 14 preparation details", "evidence_access": "Retained body checksum verified and public web source rechecked this pass." }, { "finding_id": "bc01_presentation", "status": "source_supported_different_presentation", "observation": "The HLX02-BC01 protocol describes the experimental medicine as 150 mg lyophilized powder per vial, reconstituted with sterile water, with docetaxel supplied separately. The 420 mg Canadian kit is not established by these trial preparation instructions.", "source_url": "https://cdn.clinicaltrials.gov/large-docs/37/NCT03084237/Prot_SAP_000.pdf", "source_sha256": "6cff1fe32601f51b37a84e0cc4c8a1a3b62d8aa2663e1d9646051d3e4d505112", "source_locator": "Physical PDF pages 35-38, sections 5.2 and 5.6.1", "evidence_access": "Retained body checksum verified and public web source rechecked this pass." } ], "concrete_evidence_available_now": [ "A source-bound distinction between packaging (kit: vial and diluent) and primary dosage form (powder for IV solution), preserving both raw DPD fields.", "An explicit source-linked submission/study reference for each NCT ID, qualified as not establishing the selected Canadian 420 mg presentation.", "Specific source pages showing the studied 150 mg presentation and why identical reconstituted concentration is insufficient." ], "evidence_not_supplied": [ "An applicable regulator or manufacturer document linking the clinical 150 mg HLX02 preparation to Canadian DIN 02550989 / 420 mg multidose kit for these exact studies or an explicitly applicable development program.", "An independent human approval of the source interpretation and permitted relation." ], "unsafe_substitutions_to_reject": [ "Treating mg/kg dosing as vial strength.", "Treating equal reconstituted concentration as presentation identity.", "Using a comparator vial description as HLX02 evidence.", "Using another country's single-dose 420 mg label or the distinct HV02 study as the missing Canadian HV01/BC01 kit bridge." ], "recommended_product_copy": "Health Canada discusses this study in the Adheroza submission. The retained trial evidence describes a 150 mg vial. A link to this selected Canadian 420 mg kit presentation has not been established." }, "remaining_human_work": { "can_be_prepared_by_ai": [ "Assemble source locators and immutable evidence receipts.", "Flag incorrect scope, conflicting presentation details and missing bridges.", "Prepare a reviewer worksheet and bounded proposed disposition." ], "requires_actual_reviewer": [ "Inspect sources for the 25 complete preparations.", "Record an independent approval, rejection or request for evidence with rationale against the exact candidate digest.", "For any approved relation, retain whether it is direct presentation evidence or an explicit development bridge and preserve cohort/arm/date limitations." ], "existing_gate": "validateReviewDecision requires an authorized human reviewer who is independent of the recorded evidence preparer, plus source, product-scope and independence attestations.", "no_gate_change_recommended": true }, "public_summary": "27 AI-prepared cases were checked again for source integrity and review readiness. Their retained review states remain: 25 awaiting independent human approval and 2 awaiting additional presentation evidence. This is not a clinical accuracy score or a completed human review.", "inventory": [ { "case_id": "pf-102891-02540207-NCT04732871", "din": "02540207", "product_name": "AREXVY", "ingredient_strengths": "RESPIRATORY SYNCYTIAL VIRUS PREFUSION F PROTEIN (RSVPREF3) \u2014 120 MCG / 0.5 ML", "study_id": "NCT04732871", "state": "awaiting_approval", "candidate_digest": "90cf90536609be7ba643cc9c9c2c4468c0ef8af6140b67333e946d52c847283f", "source_archive_count": 2, "evidence_anchor_count": 7, "selected_registry_arms_checked": 3, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102891-02540207-NCT04841577", "din": "02540207", "product_name": "AREXVY", "ingredient_strengths": "RESPIRATORY SYNCYTIAL VIRUS PREFUSION F PROTEIN (RSVPREF3) \u2014 120 MCG / 0.5 ML", "study_id": "NCT04841577", "state": "awaiting_approval", "candidate_digest": "48577d2decd4f358d3d3e2c3d23a415fda7a4522e4da4d63ad688d9ae6ec4fc3", "source_archive_count": 2, "evidence_anchor_count": 7, "selected_registry_arms_checked": 2, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102891-02540207-NCT04886596", "din": "02540207", "product_name": "AREXVY", "ingredient_strengths": "RESPIRATORY SYNCYTIAL VIRUS PREFUSION F PROTEIN (RSVPREF3) \u2014 120 MCG / 0.5 ML", "study_id": "NCT04886596", "state": "awaiting_approval", "candidate_digest": "2b9293c9a20679ea7cd8e5ccc970b08224667167a4fbe199cb550630c71e0db8", "source_archive_count": 3, "evidence_anchor_count": 9, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-106527-02562383-NCT03887455", "din": "02562383", "product_name": "LEQEMBI", "ingredient_strengths": "LECANEMAB \u2014 100 MG / ML", "study_id": "NCT03887455", "state": "awaiting_approval", "candidate_digest": "1dfbce6f2c391718ee973227e3367b5610fc953a8da6b1c13bc3fa1029a0148b", "source_archive_count": 3, "evidence_anchor_count": 11, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-103005-02541416-NCT03470922", "din": "02541416", "product_name": "OPDUALAG", "ingredient_strengths": "NIVOLUMAB \u2014 240 MG / 20 ML | RELATLIMAB \u2014 80 MG / 20 ML", "study_id": "NCT03470922", "state": "awaiting_approval", "candidate_digest": "06d487115fdecbdd692fc743628f1501ebd370f6d6998c0146b6819e8592d195", "source_archive_count": 2, "evidence_anchor_count": 9, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-106527-02562383-NCT01767311", "din": "02562383", "product_name": "LEQEMBI", "ingredient_strengths": "LECANEMAB \u2014 100 MG / ML", "study_id": "NCT01767311", "state": "awaiting_approval", "candidate_digest": "a1ddf341edb086ecd093e04cd22eb8573106dab21b7bf9a0850d9f3f82253724", "source_archive_count": 4, "evidence_anchor_count": 12, "selected_registry_arms_checked": 6, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102229-02533294-NCT03500549", "din": "02533294", "product_name": "EMPAVELI", "ingredient_strengths": "PEGCETACOPLAN \u2014 1080 MG / 20 ML", "study_id": "NCT03500549", "state": "awaiting_approval", "candidate_digest": "f15dfbf984736c73c971d1f57856a325e1beab5ef8ba2e9ec48691a87b576cb2", "source_archive_count": 2, "evidence_anchor_count": 7, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102287-02533979-NCT03777059", "din": "02533979", "product_name": "QULIPTA", "ingredient_strengths": "ATOGEPANT \u2014 10 MG", "study_id": "NCT03777059", "state": "awaiting_approval", "candidate_digest": "7316324b7c81292d9fca21987d8471a4f06c9537b87f059c31b80e8abf65e275", "source_archive_count": 2, "evidence_anchor_count": 6, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102287-02533979-NCT02848326", "din": "02533979", "product_name": "QULIPTA", "ingredient_strengths": "ATOGEPANT \u2014 10 MG", "study_id": "NCT02848326", "state": "awaiting_approval", "candidate_digest": "e7f3efc701fd4cce59f233aea148e7a79a4a6143931e1bc28b9bb264d7bee6f8", "source_archive_count": 4, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102293-02533987-NCT03777059", "din": "02533987", "product_name": "QULIPTA", "ingredient_strengths": "ATOGEPANT \u2014 30 MG", "study_id": "NCT03777059", "state": "awaiting_approval", "candidate_digest": "7541f8483a923e93d82e9da9e002969b92f5449bf63943b586c5110f444b3b9a", "source_archive_count": 2, "evidence_anchor_count": 6, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102293-02533987-NCT02848326", "din": "02533987", "product_name": "QULIPTA", "ingredient_strengths": "ATOGEPANT \u2014 30 MG", "study_id": "NCT02848326", "state": "awaiting_approval", "candidate_digest": "aa9ca5afa845ecca26abb4efe0529f414d6dfa01178da7698fa3ec3f1558e40b", "source_archive_count": 4, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102294-02533995-NCT03777059", "din": "02533995", "product_name": "QULIPTA", "ingredient_strengths": "ATOGEPANT \u2014 60 MG", "study_id": "NCT03777059", "state": "awaiting_approval", "candidate_digest": "30205f241a82c8b7d2181f5063adf9d91bf3153059226d8f5db75ca2e53a4132", "source_archive_count": 2, "evidence_anchor_count": 6, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102294-02533995-NCT02848326", "din": "02533995", "product_name": "QULIPTA", "ingredient_strengths": "ATOGEPANT \u2014 60 MG", "study_id": "NCT02848326", "state": "awaiting_approval", "candidate_digest": "781f371d59fc644f71500770a42e915a1e07adc85212d6f0a39e4ee86c63bdaf", "source_archive_count": 4, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-107134-02569078-NCT05072080", "din": "02569078", "product_name": "VIMKUNYA", "ingredient_strengths": "CHIKUNGUNYA VIRUS VIRUS-LIKE PARTICLE \u2014 40 MCG / 0.8 ML", "study_id": "NCT05072080", "state": "awaiting_approval", "candidate_digest": "b0d970aa6d8f9638fad8e2b08c3ed55258954d4e0ef6a6d4a84ef9be2a29b622", "source_archive_count": 2, "evidence_anchor_count": 8, "selected_registry_arms_checked": 3, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-107134-02569078-NCT05349617", "din": "02569078", "product_name": "VIMKUNYA", "ingredient_strengths": "CHIKUNGUNYA VIRUS VIRUS-LIKE PARTICLE \u2014 40 MCG / 0.8 ML", "study_id": "NCT05349617", "state": "awaiting_approval", "candidate_digest": "ea02ab534516b410a4c292c3fc561f4f8d5269f696d760370b5d81f54740c626", "source_archive_count": 2, "evidence_anchor_count": 8, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102312-02534177-NCT03247673", "din": "02534177", "product_name": "VEGZELMA", "ingredient_strengths": "BEVACIZUMAB \u2014 100 MG / 4 ML", "study_id": "NCT03247673", "state": "awaiting_approval", "candidate_digest": "1a0f805030d0e9e4dedae9ec7369718201980a279715896f37005ebeb4d613c4", "source_archive_count": 4, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102313-02534185-NCT03247673", "din": "02534185", "product_name": "VEGZELMA", "ingredient_strengths": "BEVACIZUMAB \u2014 400 MG / 16 ML", "study_id": "NCT03247673", "state": "awaiting_approval", "candidate_digest": "b2441b396d079398b638df129cbf5aef9c58c6051ce3d03a64ec50541ab7f4ec", "source_archive_count": 3, "evidence_anchor_count": 7, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102312-02534177-NCT03676192", "din": "02534177", "product_name": "VEGZELMA", "ingredient_strengths": "BEVACIZUMAB \u2014 100 MG / 4 ML", "study_id": "NCT03676192", "state": "awaiting_approval", "candidate_digest": "c0318bb47b1c3ede056b27c92df67fb38bb3bec3692945b769f672beec3ccbcd", "source_archive_count": 4, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102313-02534185-NCT03676192", "din": "02534185", "product_name": "VEGZELMA", "ingredient_strengths": "BEVACIZUMAB \u2014 400 MG / 16 ML", "study_id": "NCT03676192", "state": "awaiting_approval", "candidate_digest": "b12e333b1393e8b6a94b5870eceb9d7a8416472d8170c1b0a5dc1299fbee2919", "source_archive_count": 3, "evidence_anchor_count": 7, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102487-02536080-NCT04083781", "din": "02536080", "product_name": "ALHEMO", "ingredient_strengths": "CONCIZUMAB \u2014 15 MG / 1.5 ML", "study_id": "NCT04083781", "state": "awaiting_approval", "candidate_digest": "1efab258de87c1e8ca73845267c1dcb382b35761cb21a37446a2d68939276465", "source_archive_count": 4, "evidence_anchor_count": 13, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102490-02536099-NCT04083781", "din": "02536099", "product_name": "ALHEMO", "ingredient_strengths": "CONCIZUMAB \u2014 60 MG / 1.5 ML", "study_id": "NCT04083781", "state": "awaiting_approval", "candidate_digest": "bcd35e260310c08db8ca09e2bd63f77fdd6533496b1de86ca65967526c3cd92a", "source_archive_count": 3, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102491-02536102-NCT04083781", "din": "02536102", "product_name": "ALHEMO", "ingredient_strengths": "CONCIZUMAB \u2014 150 MG / 1.5 ML", "study_id": "NCT04083781", "state": "awaiting_approval", "candidate_digest": "3eda3a33183c61839679c54be0a782562206db5f0683e84d84dffcab50edf408", "source_archive_count": 3, "evidence_anchor_count": 10, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-102492-02536110-NCT04083781", "din": "02536110", "product_name": "ALHEMO", "ingredient_strengths": "CONCIZUMAB \u2014 300 MG / 3 ML", "study_id": "NCT04083781", "state": "awaiting_approval", "candidate_digest": "5084086aee7d1539d0da9eac499639cacb168409f9f3140ba1b9bd3b5375f782", "source_archive_count": 4, "evidence_anchor_count": 13, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-103973-02550970-NCT02581748", "din": "02550970", "product_name": "ADHEROZA", "ingredient_strengths": "TRASTUZUMAB \u2014 150 MG / VIAL", "study_id": "NCT02581748", "state": "awaiting_approval", "candidate_digest": "6e1ebf55af43244f518a60edb999917bd0e10749de70302b2b07f47f264a3191", "source_archive_count": 3, "evidence_anchor_count": 11, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-103973-02550970-NCT03084237", "din": "02550970", "product_name": "ADHEROZA", "ingredient_strengths": "TRASTUZUMAB \u2014 150 MG / VIAL", "study_id": "NCT03084237", "state": "awaiting_approval", "candidate_digest": "3ce6b15dfc9e3d441d1734e2c805f0c034a97664c77e117a467c99eca9728835", "source_archive_count": 3, "evidence_anchor_count": 8, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-103974-02550989-NCT02581748", "din": "02550989", "product_name": "ADHEROZA", "ingredient_strengths": "TRASTUZUMAB \u2014 420 MG / VIAL", "study_id": "NCT02581748", "state": "needs_further_evidence", "candidate_digest": "23da9d022e885b1549e16fdb5ffed5170109b9448c225d852eabf81424d1e83f", "source_archive_count": 4, "evidence_anchor_count": 14, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false }, { "case_id": "pf-103974-02550989-NCT03084237", "din": "02550989", "product_name": "ADHEROZA", "ingredient_strengths": "TRASTUZUMAB \u2014 420 MG / VIAL", "study_id": "NCT03084237", "state": "needs_further_evidence", "candidate_digest": "032e680d4bdd81191acff1f2ca2ea5f78aaf9dbcb7d42deb25b02c4c489137ba", "source_archive_count": 4, "evidence_anchor_count": 11, "selected_registry_arms_checked": 1, "preparation_only": true, "human_approval_performed": false } ] }