ImmuCell Announces Change in Timing of Anticipated FDA Submission
June 28 2023 - 3:05PM
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, today announced a change to its
anticipated FDA submission schedule.
“Although we had planned to make our next FDA submission during
the second quarter of this year, we have decided to add one
additional month to the projected regulatory development process
for Re-Tain®,” commented Michael F. Brigham,
President and CEO of ImmuCell. “The CMC Technical Section is ready
for submission at this time, but we are going to use this extra
time to optimize our readiness for the related pre-approval
re-inspection.”
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
CEOImmuCell Corporation(207) 878-2770Joe Diaz, Robert Blum and Joe
DorameLytham Partners, LLC(602)
889-9700iccc@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
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“aims”, “intends”, “would”, “could”, “should”, “will”, “plans”,
“believes”, “estimates”, “targets”, “projects”, “forecasts”,
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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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