Brief: Immucell Receives Technical Section Incomplete Letter From FDA Pertaining To Re-Tain

ImmuCell

28/07/2022 01:09

July 27 (Reuters) - ImmuCell Corp  ICCC.O :
    * IMMUCELL RECEIVES TECHNICAL SECTION INCOMPLETE LETTER FROM
FDA
PERTAINING TO RE-TAIN
    * PRINCIPAL ISSUE REMAINING IS A SUCCESSFUL PRE-APPROVAL
RE-INSPECTION OF ITS MANUFACTURING FACILITY
    * COMPLETING PREPARATIONS FOR SUCH AND INTENDS TO NOTIFY THE
FDA
OF ITS READINESS FOR THE RE-INSPECTION DURING THE THIRD QUARTER
    * COMPANY INTENDS TO MAKE A THIRD SUBMISSION OF ITS CMC
TECHNICAL
SECTION IN RESPONSE TO THESE QUESTIONS DURING Q3
    * FINALIZING THE REMAINING MINOR TECHNICAL SECTIONS AND
PREPARING
TO FILE THE ADMINISTRATIVE NADA WHILE PLANNING FOR MARKET LAUNCH
    * SIX COMMENTS RECEIVED FROM FDA APPEAR NOT TO BE
SUBSTANTIVE AND
ARE NOT RELATED TO SAFETY NOR EFFICACY OF PRODUCT

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

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