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<SEC-DOCUMENT>0001102624-11-000100.txt : 20110218
<SEC-HEADER>0001102624-11-000100.hdr.sgml : 20110218
<ACCEPTANCE-DATETIME>20110218154457
ACCESSION NUMBER:		0001102624-11-000100
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110216
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110218
DATE AS OF CHANGE:		20110218

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			IMMUCELL CORP /DE/
		CENTRAL INDEX KEY:			0000811641
		STANDARD INDUSTRIAL CLASSIFICATION:	IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
		IRS NUMBER:				010382980
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12934
		FILM NUMBER:		11624436

	BUSINESS ADDRESS:	
		STREET 1:		56 EVERGREEN DR
		CITY:			PORTLAND
		STATE:			ME
		ZIP:			04103
		BUSINESS PHONE:		2078782770

	MAIL ADDRESS:	
		STREET 1:		56 EVERGREEN DRIVE
		CITY:			PORTLAND
		STATE:			ME
		ZIP:			04103
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">Date of Report: February 16, 2011</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">Item 8.01&#160;&#160;Other Events</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">On February 16, 2011 ImmuCell Corporation (the "Company") issued a press release announcing that it received an Effectiveness Technical Section Incomplete Letter from the Center for Veterinary Medicine, U.S. Food and Drug Administration.&#160;&#160;The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">The information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act (the "Exchange Act") or otherwise subject to liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 of the Exchange Act, except as expressly set forth by specific reference in such filing.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman"><font id="TAB2" style="LETTER-SPACING: 9pt">&#160;&#160;&#160;</font>&#160;Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</font></div>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;<font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">Dated: February 18, 2011</font></font></td>
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<div style="DISPLAY: block; TEXT-INDENT: 0pt"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">IMMUCELL CORPORATION</font></font></div>
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<div style="DISPLAY: block; TEXT-INDENT: 0pt"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">By: <font style="TEXT-DECORATION: underline">/s/ Michael F. Brigham&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font></font></font></div>
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<div align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Press Release of ImmuCell Corporation dated February 16, 2011.</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt; TEXT-ALIGN: left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 12pt; FONT-FAMILY: Times New Roman"><img src="immucellogo.jpg" alt=""></font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 12pt; FONT-FAMILY: Times New Roman">IMMUCELL RECEIVES EFFECTIVENESS TECHNICAL SECTION INCOMPLETE LETTER FROM FDA</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">PORTLAND, Maine &#8211;&#160;&#160;February 16, 2011 -- <font style="DISPLAY: inline; FONT-WEIGHT: bold">ImmuCell Corporation (NASDAQ: ICCC)</font> today announced that it received an Effectiveness Technical Section Incomplete Letter from the Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA).</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#8220;While this is a setback to our development program in terms of timing, there is nothing in this communication that suggests the FDA will not ultimately concur with our fundamental conclusions about the effectiveness of <font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font>,&#8221; commented Joseph H. Crabb, Vice President and Chief Scientific Officer.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Additional clinical studies are not required.&#160;&#160;The FDA has requested additional information in the areas of raw data, subject eligibility and statistical analyses and has requested that certain treatment outcomes be changed or justified.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#8220;It is a disappointment not to have received approval of this lengthy submission, but this is not an unusual path for a drug development program of this magnitude,&#8221; added Michael F. Brigham, President and CEO.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">This Technical Section submission was comprised of data from a study completed in 2009 of approximately 300 qualified cows with subclinical mastitis conducted at sixteen sites across the United States.&#160;&#160;The <font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> treatment group showed a statistically, highly significant&#160;&#160;(p &lt; 0.0001) overall cure rate in comparison to the placebo group.&#160;&#160;The response to the items detailed in the Technical Section Incomplete Letter is not expected to materially change these initial conclusions.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -9.35pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Commercial introduction of <font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top;" face="Symbol, serif">&#210;</font> in the United States is subject to review and approval of our administrative New Animal Drug Application (NADA) submission by the FDA, which approval cannot be assured.&#160;&#160;The NADA is comprised of five Technical Sections under the FDA&#8217;s phased review of a NADA.&#160;&#160;The Effectiveness Technical Section is one of these.&#160;&#160;The Company intends to continue disclosing the current status of each Technical Section in its periodic filings with the Securities and Exchange Commission.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">By acquiring certain rights and patents in April 2000, ImmuCell began its development of <font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top;" face="Symbol, serif">&#210;</font>,<font style="DISPLAY: inline; FONT-WEIGHT: bold">&#160;</font>which is<font style="DISPLAY: inline; FONT-WEIGHT: bold">&#160;</font>an intramammary infusion product containing Nisin for the treatment of subclinical mastitis in lactating dairy cows.&#160;&#160;The dual purpose of such a subclinical treatment would be to both clear the infection at an early stage and earn premiums for higher quality milk (low Somatic Cell Counts).&#160;&#160;Many fear that the possible overuse of antibiotics in livestock could undermine the effectiveness of drugs to combat human illnesses and may be a
 contributing factor to the rising problem of bacterial drug resistance.&#160;&#160;The FDA is committed to addressing its concern with respect to this important public health issue.&#160;&#160;<font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top;" face="Symbol, serif">&#210;</font> could potentially reduce the use of traditional antibiotics that are currently approved for use in the treatment of mastitis.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 5.4pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Nisin (which is the same active ingredient contained in ImmuCell&#8217;s product, <font style="DISPLAY: inline; FONT-WEIGHT: bold">Wipe Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top;" face="Symbol, serif">&#210;</font><font style="DISPLAY: inline; FONT-WEIGHT: bold"> Dairy Wipes)</font> is<font style="DISPLAY: inline; FONT-WEIGHT: bold">&#160;</font>an antibacterial peptide that is commonly used as a preservative in dairy food products.&#160;&#160;Nisin is known to have activity against most gram positive and some gram negative bacteria.&#160;&#160;The label claim allowing the use of <font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top;" face="Symbol, serif">&#210;</font> without a milk discard requirement is subject to a
pproval of the Human Food Safety Technical Section that was submitted to the FDA for review during the fourth quarter of 2010.&#160;&#160;<font style="DISPLAY: inline; FONT-WEIGHT: bold">Mast Out</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top;" face="Symbol, serif">&#210;</font> could be the first product of its kind with such a claim, which would allow it to compete effectively against products currently on the market that are all used subject to a requirement to discard milk during treatment and for a period of time thereafter.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About ImmuCell:</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">ImmuCell Corporation&#8217;s (NASDAQ: ICCC) purpose is to create scientifically-proven and practical products that result in a measurable economic impact on animal health and productivity in the dairy and beef industries.&#160;&#160;Press releases and other information about the Company are available at our web-site, (<font style="DISPLAY: inline; TEXT-DECORATION: underline">http://www.immucell.com</font>).</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -9.35pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Contact:</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -9.35pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Michael F. Brigham</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -9.35pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">President and Chief Executive Officer</font></div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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