secwatch.observer — SEC 8-K summary
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Issuer:     IMMUCELL CORP /DE/ (ICCC)
CIK:        0000811641
Form:       8-K
Filed at:   2024-06-06T23:59:59+00:00
Accession:  0001213900-24-050197
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

ImmuCell provides Re-Tain® FDA update; NADA submission after contract manufacturer clearance
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/811641/000121390024050197/0001213900-24-050197-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/811641/000121390024050197/ea0207422-8k_immucell.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-050197

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer