{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-050197","form_type":"8-K","ticker":"ICCC","cik":"0000811641","company_name":"IMMUCELL CORP /DE/","filed_at":"2024-06-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:22.042958+00:00","generated_at":"2026-06-01T06:06:15.221053+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"ImmuCell provides Re-Tain® FDA update; NADA submission after contract manufacturer clearance","bullets":["Received FDA Incomplete Letter on CMC Technical Section for Re-Tain®; fourth submission prepared.","ImmuCell's drug substance facility inspection cleared; contract manufacturer responses due by end of June 2024.","Anticipates submitting Non-Administrative NADA with up to 180-day review, possibly shorter.","Targets product expiration dating between Q2 2025 and Q1 2026, subject to FDA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-050197","json":"https://secwatch.observer/filing/0001213900-24-050197.json","markdown":"https://secwatch.observer/filing/0001213900-24-050197.md","text":"https://secwatch.observer/filing/0001213900-24-050197.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/811641/000121390024050197/0001213900-24-050197-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/811641/000121390024050197/ea0207422-8k_immucell.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T06:06:15.221053+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"}