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Protalix Says FDA Extends Taliglucerase Alfa PDUFA Date To May 1, 2012

Protalix BioTherapeutics, Inc. (PLX) Tuesday said it has received notification from the U.S. Food and Drug Administration that the FDA has extended the Prescription Drug User Fee Act goal date of the New Drug Application for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

Taliglucerase alfa is the Company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase, which is being developed for the treatment of Gaucher disease.

In November 2011, the Company submitted certain clinical information regarding taliglucerase alfa in response to an FDA request. This request related mainly to the presentation of select data provided in the NDA.

by RTT Staff Writer

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