{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-036710","form_type":"8-K","ticker":"FLNA","cik":"0001069530","company_name":"FILANA THERAPEUTICS, INC.","filed_at":"2025-12-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.713187+00:00","generated_at":"2026-05-16T15:00:30.336550+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Cassava Sciences receives FDA request for additional info on simufilam IND for TSC-related epilepsy","bullets":["Submitted IND for simufilam in tuberous sclerosis complex (TSC)-related epilepsy.","FDA notified Company on Nov 26, 2025, then on Dec 2, 2025, requesting additional info to assess risks.","Company expects formal FDA letter with details; will work collaboratively to address issues.","Proof-of-concept study initiation still targeted for first half of 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-036710","json":"https://secwatch.observer/filing/0001437749-25-036710.json","markdown":"https://secwatch.observer/filing/0001437749-25-036710.md","text":"https://secwatch.observer/filing/0001437749-25-036710.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1069530/000143774925036710/0001437749-25-036710-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1069530/000143774925036710/sava20251201_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T15:00:30.336550+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"}