{"service":"biotech catalyst / FDA regulatory-decision calendar","method":"Deterministic regex/structural extraction (NO LLM) of regulatory-decision dates from PRIMARY SEC filings. Every date is grounded in an in-sentence quote co-occurring with an event keyword; no keyword<->date co-occurrence means the date is NOT emitted (precision-first: an honest miss, never invented).","sources":[{"key":"sec_efts","name":"SEC EDGAR full-text search","url":"https://efts.sec.gov/LATEST/search-index","license":"US public domain (SEC EDGAR)"},{"key":"sec_archives","name":"SEC EDGAR primary filing documents","url":"https://www.sec.gov/Archives/edgar/data","license":"US public domain (SEC EDGAR)"}],"event_types":[{"id":"pdufa","label":"PDUFA target action date","keywords":["pdufa","target action date","prescription drug user fee act","goal date","pdufa action date","pdufa date","action date"],"description":"FDA target decision date for a marketing application (NDA/BLA), set under PDUFA."},{"id":"adcomm","label":"FDA advisory committee meeting","keywords":["advisory committee","advisory committee meeting","adcom","odac","advisory committee will","advisory committee is scheduled"],"description":"Date of an FDA advisory committee (AdComm) meeting reviewing an application."},{"id":"crl","label":"Complete Response Letter","keywords":["complete response letter","crl"],"description":"FDA Complete Response Letter — a decision NOT to approve in the current form."},{"id":"priority_review","label":"Priority review","keywords":["priority review"],"description":"FDA priority-review designation (shortens the PDUFA review clock to ~6 months)."},{"id":"pdufa_extension","label":"PDUFA extension","keywords":["extended the pdufa","extension of the review","three-month extension","pdufa goal date has been extended","extended pdufa","new pdufa"],"description":"An extension of a previously-set PDUFA goal date (a superseding/pushed date)."}],"forms":["8-K","6-K"],"caps":{"max_docs_calendar":8,"max_docs_upcoming":15,"default_lookback_days":270,"default_forward_days":365,"keyword_date_distance_chars":160},"coverage_gaps":["Coarse-granularity guidance (e.g. 'mid-2026', 'second half of 2026', 'first quarter') is NOT emitted — only specific calendar dates (precision-first).","A bare 'Month Day' with no year has its year inferred from the filing date and is flagged year_inferred:true.","AdComm/CHMP phrasing is diverse; recall is lower than PDUFA (precision-first, recall is not guaranteed)."],"attribution":"SEC EDGAR (public domain); efts.sec.gov full-text search + www.sec.gov filings.","disclaimer":"Informational calendar extracted from primary SEC filings. Regulatory dates are set by the FDA and may be extended, missed or superseded; each date is quoted from the cited filing. Not investment advice."}