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

Protalix BioTherapeutics, Inc.

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)

 

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.

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.