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 1, 2011
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Florida
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001-33357
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65-0643773
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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2 Snunit Street
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20100
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Science Park, POB 455
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Carmiel, Israel
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(Address of principal executive offices)
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(Zip Code)
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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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01. Other Events
On August 1, 2011, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that it has submitted its reply to the Complete Response Letter issued in February 2011 by the U.S. Food and Drug Administration after its review of the Company’s New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. The reply includes top-line results from the Company’s switchover trial. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
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99.1
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Press Release dated August 1, 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.
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PROTALIX BIOTHERAPEUTICS, INC. |
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Date: August 1, 2011
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By:
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David Aviezer |
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Name: |
David Aviezer, Ph.D. |
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Title: |
President and Chief Executive Officer |
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