ImmuCell Announces Submission of CMC Technical Section to the FDA
August 29 2023 - 8:00AM
ImmuCell Corporation (Nasdaq: ICCC)
(“ImmuCell” or the “Company”), a growing animal health company that
develops, manufactures and markets scientifically proven and
practical products that improve the health and productivity of
dairy and beef cattle, announced today that it recently
submitted the Chemistry, Manufacturing and Controls (CMC) Technical
Section for
Re-Tain® to the FDA.
On August 10, 2023, the Company issued a disclosure stating that
it anticipated making this submission “shortly” after the filing of
its Quarterly Report on Form 10-Q. The Company is now confirming
that this objective was achieved.
“For the benefit of clarity, we want to inform investors that
this important step in the regulatory process was taken on August
18, 2023,” commented Michael F. Brigham, President and CEO of
ImmuCell. “This kind of submission is subject to a six-month review
by the FDA, and we are excited about the opportunity ahead.”
About ImmuCell:ImmuCell Corporation's
(Nasdaq: ICCC) purpose is to create scientifically
proven and practical products that improve the health and
productivity of dairy and beef cattle. ImmuCell manufactures
and markets First Defense®, providing
Immediate Immunity™ to newborn dairy and beef
calves, and is in the late stages of developing
Re-Tain®, a novel treatment for subclinical
mastitis in dairy cows without a milk discard requirement that
provides an alternative to traditional antibiotics. Press releases
and other information about the Company are available at:
http://www.immucell.com.
Contacts: |
Michael F. Brigham, President and CEO |
|
ImmuCell Corporation |
|
(207) 878-2770 |
|
|
|
Joe Diaz, Robert Blum and Joe
Dorame |
|
Lytham Partners, LLC |
|
(602) 889-9700 |
|
iccc@lythampartners.com |
Cautionary Note Regarding Forward-Looking Statements
(Safe Harbor
Statement):This Press Release contains or may
contain “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements can be identified by the fact that they
do not relate strictly to historical or current facts and will
often include words such as “expects”, “may”, “anticipates”,
“aims”, “intends”, “would”, “could”, “should”, “will”, “plans”,
“believes”, “estimates”, “targets”, “projects”, “forecasts”,
“seeks” and similar words and expressions. Such statements include,
but are not limited to, any forward-looking statements relating to:
our plans and strategies for our business; projections of future
financial or operational performance; the scope and timing of
ongoing and future product development work and commercialization
of our products; the timing and completeness of any regulatory
submissions or milestones and possible regulatory approval of any
of our products (including
Re-Tain®) and any other
statements that are not historical facts. These statements are
intended to provide management's current expectation of future
events as of the date of this Press Release, are based on
management's estimates, projections, beliefs and assumptions as of
the date hereof; and are not guarantees of future performance. Such
statements involve known and unknown risks and uncertainties that
may cause the Company's actual results, financial or operational
performance or achievements to be materially different from those
expressed or implied by these forward-looking statements,
including, but not limited to, those risks and uncertainties
detailed from time to time in filings we make with the Securities
and Exchange Commission (SEC), including our Quarterly Reports on
Form 10-Q, our Annual Reports on Form 10-K and our Current Reports
on Form 8-K. In addition, there can be no assurance that future
risks, uncertainties or developments affecting us will be those
that we anticipate. We undertake no obligation to update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
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