SPX4,274.04-31.16 -0.72%
DIA340.20-1.54 -0.45%
IXIC12,938.12-164.43 -1.25%

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

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

Reuters · 07/27/2022 20:09
BRIEF-Immucell Receives Technical Section Incomplete Letter From FDA Pertaining To Re-Tain

- ImmuCell Corp ICCC:

  • 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

Source text for Eikon: ID:

Further company coverage: ICCC


((Reuters.Brief@thomsonreuters.com;))