8-K
 
 
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): July 14, 2009
 
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
         
Florida   000-27836   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):
o     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o     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 July 14, 2009, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that it held a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to discuss the Company’s proposed new drug application (NDA) submission for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase, for the treatment of Gaucher disease and to confirm the clinical, nonclinical and chemistry requirements for the proposed NDA filing. 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 July 14, 2009.

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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: July 14, 2009  By:   /s/ David Aviezer    
    Name:   David Aviezer, Ph.D.   
    Title:   President and Chief Executive Officer   
 

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