{"schema":"sb.node.v1","id":"sb:e/c30896a4d2aa68eb4d750324","kind":"entity","label":{"text":"biologics license application","locale":"en"},"identity":{"anchor":"label:en:biologics license application","strength":"label"},"asOf":{"knowledgeCutoff":"2026-10-07T17:37:52.548784+00:00","snapshot":"deploy f96c9fec564ffd4326cb9684cfa400abbd8e63a8"},"lens":{"kind":"public"},"build":{"plane":"projected","builtFrom":["entity_graph.slim.json","entity_receipts (deploy asset)","event_graph.json","truth_records (deploy asset)","corroborated_record.json"],"rule":"node-projection.entity@v1"},"standing":{"evidence":{"supporting":33,"separatePublishers":12,"basis":"documents that mention the subject and the outlets that carried them; a mention is evidence the referent is in use, not evidence about any claim"},"admission":{"state":"provisional","reason":"entity graph provenance 'observed'; the node carries no promotion receipt in v1","policy":"EQ-PROMOTION (receipt not carried)"},"disposition":{"state":"served","reason":"public record"},"validity":{"from":"2026-09-04","to":"2026-10-06","basis":"first and last day we saw it mentioned; not the subject's own lifetime"},"measurement":{"state":"partial","blind":["assertion coverage 0.455: about 54% of mentions carry no typed assertion"]}},"dimensions":{"domains":["auto","biotech_pharma","fda_decisions"],"activeDays":20,"assertions":{"regulatory-approval":5,"legal-ruling":4,"meeting-visit":3,"utterance":1,"price-threshold":1,"funding-round":1}},"up":[],"upNote":"An entity is a root: it is contained by nothing. Pan out by following R.","children":{"count":11,"byKind":{"observation":11},"withheld":{"state":"withheld","count":1,"reason":"1 receipt withheld: no source link (the same rule the topic record applies)"},"items":[{"id":"sb:o/65a2d8d5b4a7232f128512f1","kind":"observation","label":"Clinical Trials Arena · 2026-10-06 · Vaxcyte’s stock up after pneumococcal vaccine proves non-inferiority","url":"https://www.clinicaltrialsarena.com/news/vaxcytes-stock-up-after-pneumococcal-vaccine-proves-non-inferiority/"},{"id":"sb:o/d4fa561650c462cf8172c74f","kind":"observation","label":"The Clinical Trial Vanguard · 2026-10-06 · Novo’s Denecimig Got a Green Light From Clinicians and a Red Light From an Inspector: Who Failed?","url":"https://www.clinicaltrialvanguard.com/clinops-watchdog/novos-denecimig-got-a-green-light-from-clinicians-and-a-red-light-from-an-inspector-who-failed/"},{"id":"sb:o/46c9fc06418d5630b3f757b8","kind":"observation","label":"AllSci News · 2026-10-05 · US FDA delays review of Novo hemophilia drug denecimig over manufacturing issue","url":"https://allsci.com/news/biotech/denecimig-approval-fda-manufacturing-review/"},{"id":"sb:o/984fba6689d364802c6c3f86","kind":"observation","label":"The Clinical Trial Vanguard · 2026-10-03 · FDA extends denecimig review timeline, no decision date set","url":"https://www.clinicaltrialvanguard.com/news/fda-extends-denecimig-review-timeline-no-decision-date-set/"},{"id":"sb:o/4b59c8fb3eb41d28a6742218","kind":"observation","label":"AllSci News · 2026-10-02 · Pierre Fabre, Atara resubmit Ebvallo BLA after two FDA CRLs","url":"https://allsci.com/news/biotech/tabelecleucel-fda-approval-atara-resubmits/"},{"id":"sb:o/eb86097d896d3fbaef88184c","kind":"observation","label":"AllSci News · 2026-10-02 · AstraZeneca, Daiichi team with Summit to pair Datroway with ivonescimab in Phase III TNBC push","url":"https://allsci.com/news/biotech/datroway-ivonescimab-astrazeneca-and-daiichi/"},{"id":"sb:o/b61cfd3897f220f802233dcc","kind":"observation","label":"AllSci News · 2026-10-01 · Lilly’s retatrutide delivers 20.8% weight loss in Phase III diabetes-obesity trial","url":"https://allsci.com/news/clinical-trials/retatrutide-weight-loss-diabetes-lillys-achieves/"},{"id":"sb:o/915109a4a02e683296d21ab9","kind":"observation","label":"Clinical Trials Arena · 2026-10-01 · Invivyd’s Covid-directed mAb hits Phase III safety goals","url":"https://www.clinicaltrialsarena.com/news/invivyd-covid-directed-mab-hits-phase-iii-safety-goals/"},{"id":"sb:o/940e0af1d04ddb41d09f7f5f","kind":"observation","label":"European Medical Journal · 2026-09-30 · Triple-Action Weight-Loss Drug Shows Promise for Heart Health","url":"https://www.emjreviews.com/general-healthcare/news/retatrutide-triple-action-weight-loss-heart-risk-factors/"},{"id":"sb:o/a26bd38b586d0ab2c56df825","kind":"observation","label":"Clinical Trials Arena · 2026-09-30 · Mirum charts positive course for hepatitis delta drug on first Phase III win","url":"https://www.clinicaltrialsarena.com/news/mirum-chronic-hdv-phase-iii/"}],"cursor":"c1.eyJpZCI6InNiOmUvYzMwODk2YTRkMmFhNjhlYjRkNzUwMzI0IiwibCI6ImNoaWxkcmVuIiwibyI6MTAsImsiOm51bGwsImEiOiIyMDI2LTEwLTA3VDE3OjM3OjUyLjU0ODc4NCswMDowMCJ9","order":"newest first; we keep the 11 newest receipts for this entity. Its other observations are counted in standing.evidence.supporting but are not addressable in v1"},"relations":{"count":2,"byKind":{"co-mentioned":2},"items":[{"kind":"relation","label":"co-mentioned with fda (27 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/1b8e05bbc401c4e252c8cbb1"},{"kind":"relation","label":"co-mentioned with drug administration (12 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/96463f62a1399769ade54080"}],"cursor":null,"order":"situations first, then claims (the subject's own maintained record, then site-wide corroborated clusters; each label ends with its standing), then co-mentions by shared documents, descending. Co-mentions are the ten strongest the entity graph keeps per entity"},"edge":{"state":"continues"},"links":{"rest":"/api/v1/node/e/c30896a4d2aa68eb4d750324","mcp":"traverse {\"id\":\"sb:e/c30896a4d2aa68eb4d750324\"}","page":"/entity/biologics-license-application/"},"limits":{"levelsPerCall":1,"pageSize":10,"maxPageSize":50,"membersMax":50,"statement":"One level per call: depth is 1 and only 1, and there is no whole-graph dump. pageSize 1-50 (default 10); a page limit is a cursor, never an edge. Members are listed up to 50. At most 60 traverse calls a minute per caller (runaway-loop protection, not a meter). One knowledge cutoff is served: the deploy's."},"actions":[{"verb":"unfold","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/c30896a4d2aa68eb4d750324\",\"level\":\"children\"}"},{"verb":"fold","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/c30896a4d2aa68eb4d750324\"}"},{"verb":"panOut","lit":false,"effect":"read","layer":"cantina","reason":"An entity is a root: it is contained by nothing. Pan out by following R."},{"verb":"follow","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/c30896a4d2aa68eb4d750324\",\"level\":\"relations\"}"},{"verb":"receipts","lit":false,"effect":"read","layer":"cantina","reason":"receipts are the observations below this node; unfold to reach them"},{"verb":"edge","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/c30896a4d2aa68eb4d750324\"}"},{"verb":"asOf","lit":false,"effect":"read","layer":"cantina","reason":"v1 serves one knowledge cutoff, this deploy's; walking an earlier cutoff needs retained history (EQ-REPLAY), which v1 does not keep"},{"verb":"switchObserver","lit":false,"effect":"read","layer":"cantina","reason":"the public record is the same for every observer; traversal through a Watch's lens is not served in v1"},{"verb":"readOriginal","lit":false,"effect":"read","layer":"cantina","reason":"no translation is applied on this node; every label is the source's own text"},{"verb":"save","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"saving applies to a configured Watch; configure one around this node first (free), then save it"},{"verb":"deliver","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"delivery applies to a saved Watch"},{"verb":"format","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"output format applies to a saved Watch"},{"verb":"deltaR","lit":false,"effect":"read","layer":"workshop","reason":"Delta R needs a saved Watch with a previous reading"},{"verb":"read","lit":false,"effect":"read","layer":"docking-bay","reason":"one-time Reads are parked until the Commander decides their shape (#938)"}]}