Item 8.01. Other Events
On August 17, 2009, Protalix BioTherapeutics, Inc. (the "Company") issued a press release announcing that that U.S. Food and Drug Administration (FDA) has approved the Company's treatment protocol for prGCD, for the use of prGCD in patients with Gaucher disease. The Company previously announced, on July 6, 2009, that the FDA approached the Company and asked it to consider submitting a treatment protocol for prGCD in order to address an expected shortage of the current enzyme replacement therapy approved for Gaucher disease. 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, 2009.

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