Brief: ImmuCell Receives FDA Response To First CMC Submission For Re-Tain

ImmuCell

29/08/2019 13:38

Aug 29 (Reuters) - ImmuCell Corp  ICCC.O :
    * IMMUCELL RECEIVES FDA RESPONSE TO FIRST CMC SUBMISSION FOR
RE-TAIN™
    * IMMUCELL CORP - FDA ISSUED A TECHNICAL SECTION INCOMPLETE
LETTER
WITH VARIOUS REQUESTS AND QUERIES
    * IMMUCELL CORP - SECOND PHASED DRUG SUBSTANCE AND DRUG
PRODUCT
CMC TECHNICAL SECTION SUBMISSION IS EXPECTED TO BE MADE AROUND
Q3 OF 2020
    * IMMUCELL CORP - HAVING REVIEWED COMMENTS FROM FDA, SEE NO
ROAD
BLOCKS ON OUR PATH TO FDA APPROVAL FOR RE-TAIN
    * IMMUCELL CORP - BELIEVE CAN RESPOND EFFECTIVELY TO FDA'S
COMMENTS WITHOUT SIGNIFICANT ADDITIONAL COST OR TIME DELAYS

Source text for Eikon:  ID:nGNX5r6zqZ 
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 (Reuters.Briefs@thomsonreuters.com)