ImmuCell Receives FDA Response To First CMC Submission for Re-Tain™
ImmuCell Corporation (ICCC)
US:NASDAQ Investor Relations:
immucell.com/investors
Company Research
Source: GlobeNewswire
Second Submission Anticipated Around Q3 2020 PORTLAND, Maine, Aug. 29, 2019 (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 – today announced that it has received a response from the U.S. Food and Drug Administration (FDA) to its first phased Nisin Drug Substance submission of the Chemistry, Manufacturing and Controls (CMC) Technical Section for Re-Tain™, the Company’s novel treatment in development for subclinical mastitis in lactating dairy cows. Under the FDA’s phased submission process, Phase 1 concerns the Nisin Drug Substance, and Phase 2 concerns the Re-Tain™ Drug Product (formulated Nisin filled in a syringe). As part of the phased submission process, the FDA issued a Technical Section Incomplete Letter with various requests and queries in addition to re
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ICCC
Sec Filings
- 4/10/24 - Form EFFECT
- 4/10/24 - Form 424B2
- 4/10/24 - Form 424B2
- ICCC's page on the SEC website