Benzinga | Aug 24, 2021 06:37AM EDT

ImmuCell Corporation Announces FDA Has Issued Technical Section Incomplete Letter Coveirng Chemistry, Manufacturing And Controls (CMC) Technical Section For Re-Tain

ImmuCell Corporation (Nasdaq: ICCC) ("ImmuCell" or the "Company"), a growing animal health company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle, today announced that the FDA has issued a Technical Section Incomplete Letter covering the Chemistry, Manufacturing and Controls (CMC) Technical Section for Re-Tain(r) (Nisin A intramammary solution).



The CMC Technical Section covers the commercial manufacturing requirements for the Drug Substance and resulting Drug Product. The Company previously received Technical Section Complete Letters from the FDA covering the other four major Technical Sections required for product approval.

Re-Tain(r) is the Company's new subclinical mastitis treatment for lactating dairy cows without a milk discard or meat withhold requirement. The Company's objective is to demonstrate that its bacteriocin, Nisin A, can play a productive role in the treatment of subclinical mastitis in today's dairy industry by providing a novel alternative to traditional antibiotics.

"We have evaluated the FDA comments and believe we can respond with a re-submission of the CMC Technical Section during the fourth quarter of 2021 without incurring significant costs or delays," commented Michael F. Brigham, President and CEO. "While this is disappointing to us, a second review of a consolidated CMC submission like this, covering Drug Substance and sterile Drug Product, is common. If after another six-month review the FDA issues a Technical Section Complete Letter, the next step would be to file the Administrative New Animal Drug Application, which could lead to a New Animal Drug Approval after a 60-day review by the FDA, thereby positioning us for potential market launch of Re-Tain(r) during the third quarter of 2022, pending ongoing FDA input and concurrence."