ImmuCell Corporation announced that the FDA has issued a Technical Section Incomplete Letter regarding its New Animal Drug Application (NADA) for Re-Tain®. The Company received a Technical Section Incomplete Letter from the FDA with regards to its second full submission of the Chemistry, Manufacturing and Controls (CMC) Technical Section, which had been submitted for review during the first quarter of this year. The principal issue remaining is a successful pre-approval re-inspection of its manufacturing facility.

The Company is completing preparations for such and intends to notify the FDA of its readiness for the re-inspection during the third quarter. Continued focus on these preparations is critical to a successful re-inspection outcome. This clarifies the required path to product approval, if not the precise timing.

Substantive issues that could have caused further significant delays did not appear in the FDA comments, indicating that they have been resolved to the FDA's satisfaction. The six comments received appear not to be substantive and are not related to the safety nor efficacy of the product. The Company intends to make a third submission of its CMC Technical Section in response to these questions during the third quarter.

The Company is also finalizing the remaining minor technical sections (Labeling and All Other Information) and preparing to file the Administrative NADA while planning for market launch.