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EX-99.1 - EXHIBIT 99.1 - Protalix BioTherapeutics, Inc.v232609_ex99-1.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 

 
FORM 8-K
 

 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
 
Date of Report (Date of Earliest Event Reported): August 17, 2011
 

 
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
 

 
Florida
 
001-33357
 
65-0643773
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)
 
     
2 Snunit Street
   
Science Park, POB 455
   
Carmiel, Israel
 
20100
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code +972-4-988-9488
 
 
(Former name or former address, if changed since last report.)
 

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 


 
 

 
 
Item 8.01. Other Events
 
On August 17, 2011, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food & Drug Administration has accepted for review the resubmission of the taliglucerase alfa New Drug Application (the “NDA”) following the Company’s receipt of a Complete Response Letter in February 2011 with respect to the NDA.  A copy of the press release is attached hereto as Exhibit 99.1.  
 
Item 9.01.  Financial Statements and Exhibits
 
(d)          Exhibits
 
99.1
Press Release dated August 17, 2011
 
 
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SIGNATURES
 
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.
 
 
  PROTALIX BIOTHERAPEUTICS, INC.  
     
       
Date: August 17, 2011
By:
/s/ David Aviezer   
  Name:   David Aviezer, Ph.D.  
 
Title:
President and
 
   
Chief Executive Officer
 
 
 
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