Brief: Immucell Announces Submission Of Manufacturing Technical Section For Purified Nisin Product

ImmuCell

28/02/2019 19:08

Feb 28 (Reuters) - ImmuCell Corp  ICCC.O :
    * IMMUCELL ANNOUNCES SUBMISSION OF MANUFACTURING TECHNICAL
SECTION
FOR ITS PURIFIED NISIN PRODUCT
    * IMMUCELL CORP - SUBMISSION IS SUBJECT TO A SIX-MONTH
REVIEW
PERIOD AND WILL BE FOLLOWED BY A SECOND PHASED SUBMISSION
COVERING NISIN DRUG PRODUCT
    * IMMUCELL CORP - SECOND PHASED NISIN DRUG PRODUCT
SUBMISSION WILL
NOT BE MADE IN TIME TO ACHIEVE PRODUCT APPROVAL BY DECEMBER 2019
    * IMMUCELL CORP - DELAY OF SECOND PHASED NISIN DRUG PRODUCT
SUBMISSION DUE TO UNEXPECTED DIFFICULTIES AND DELAYS AT STAGE OF
DRUG PRODUCT DEVELOPMENT
    * IMMUCELL CORP - MADE REQUESTS TO ITS THIRD-PARTY
MANUFACTURER TO
MODIFY CERTAIN PROVISIONS OF ITS AGREEMENT
    * IMMUCELL - THIRD-PARTY AMENDMENT COULD INCREASE
MANUFACTURING
COSTS/ SHORTEN TERM DURING WHICH MANUFACTURING SERVICES REMAIN
AVAILABLE TO CO
    * IMMUCELL CORP - ACTIVELY INVESTIGATING MULTIPLE PATHS TO
SECURE
ALTERNATIVE FDA-APPROVED MANUFACTURING SERVICES FOR NISIN DRUG
PRODUCT
    * IMMUCELL CORP - ALTERNATE PATHS COULD EXTEND TIMELINE TO
FDA
APPROVAL PAST CURRENTLY PROJECTED GOAL OF FIRST HALF OF 2020
    * IMMUCELL CORP - ALTERNATE PATHS COULD CAUSE INTERRUPTIONS
TO
PRODUCTION AND SALE OF RE-TAIN

Source text for Eikon:  ID:nGNX6sd6rY 
Further company coverage:  ICCC.O 

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