{"schema_version":"secwatch.filing_event.v1","accession":"0001645113-24-000005","form_type":"8-K","ticker":"NVCR","cik":"0001645113","company_name":"NovoCure Ltd","filed_at":"2024-01-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.960335+00:00","generated_at":"2026-06-06T21:57:57.571462+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA accepts Novocure's PMA for TTFields in NSCLC post-platinum; decision H2 2024","bullets":["PMA application accepted for filing; FDA begins substantive review.","Submission filed Dec 15, 2023; regulatory decision expected in second half 2024.","TTFields therapy plus standard systemic therapies for NSCLC after progression on platinum-based therapy.","CEO states milestone brings therapy closer to patients with few non-toxic options.","Application based on LUNAR trial data in post-platinum NSCLC."],"urls":{"canonical":"https://secwatch.observer/filing/0001645113-24-000005","json":"https://secwatch.observer/filing/0001645113-24-000005.json","markdown":"https://secwatch.observer/filing/0001645113-24-000005.md","text":"https://secwatch.observer/filing/0001645113-24-000005.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645113/000164511324000005/0001645113-24-000005-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645113/000164511324000005/nvcr-20240118.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T21:57:57.571462+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}