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ImmuCell Announces Submission of CMC Technical Section to the FDA
PORTLAND, Maine, Aug. 29, 2023 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that
About this update from Immucell Corporation
[{"type":"text","content":"PORTLAND, Maine, Aug. 29, 2023 (GLOBE NEWSWIRE) -- 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, announced today that it recently submitted the Chemistry, Manufacturing and Controls (CMC) Technical Section for Re-Tain® to the FDA. On August 10, 2023, the Company issued a disclosure stating that it anticipated making this submission “shortly” after the filing of its Quarterly Report on Form 10-Q. The Company is now confirming that this objective was achieved. “For the benefit of clarity, we want to inform investors that this important step in the regulatory process was taken on August 18, 2023,” commented Michael F. Brigham, President and CEO of ImmuCell. “This kind of submission is subject to a six-month review by the FDA, and we are excited about the opportunity ahead.” About ImmuCell:ImmuCell Corporation's (Nasdaq: ICCC) purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell manufactures and markets First Defense®, providing Immediate Immunity™ to newborn dairy and beef calves, and is in the late stages of developing Re-Tain®, a novel treatment for subclinical mastitis in dairy cows without a milk discard requirement that provides an alternative to traditional antibiotics. Press releases and other information about the Company are available at: http://www.immucell.com. Contacts:Michael F. Brigham, President and CEO ImmuCell Corporation (207) 878-2770 Joe Diaz, Robert Blum and Joe Dorame Lytham Partners, LLC (602) 889-9700 [email protected] Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):This Press Release contains or may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and will often include words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. Such state...