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

IMMUCELL CORP /DE/

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.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.