Immucell updates status of product development initiative for Re-Tain

ImmuCell Corporation provided a regulatory update on the status of its product development initiative for Re-Tain As previously disclosed, the Company recently received a Technical Section Incomplete Letter or Incomplete Letter, from the United States Food and Drug Administration or FDA, in response to its third submission of the Chemistry, Manufacturing and Controls, CMC, Technical Section, which is its fifth and final major Technical Section required for its New Animal Drug Application or NADA. Since then, the Company has prepared the fourth submission of its CMC Technical Section, responding to the comments provided in the Incomplete Letter that are not complex. Once the facility inspection at the Drug Product facility of the Company’s contract manufacturer is cleared by the FDA, the Company anticipates submitting a Non-Administrative NADA that would include the Company’s fourth submission of the CMC Technical Section, together with the minor technical sections covering All Other Information and Product Labeling. By statute, this submission would be subject to a review period of up to 180 days. However, the Company believes that a shorter review period may be provided because the responses to the CMC Incomplete Letter are not complex. The goal of submitting this combined filing would be to eliminate the need for an additional 60-day review period of an Administrative NADA submission at the end of the application process, after all five major Technical Section Complete Letters are received. Upon FDA approval, the Company intends to implement its previously disclosed limited distribution, controlled launch strategy with product expiration dating estimated at between the second quarter of 2025 and the first quarter of 2026, subject to final product shelf-life disposition by the FDA “We will remain focused on the commercial opportunity we have with First Defense, as we push forward to finish this regulatory process to bring Re-Tain(R) to market,” commented Michael F. Brigham, President and CEO of ImmuCell.