Rochester, NY 7/15/2009 11:38:55 PM
PLX - Protalix Holds Pre-NDA Meeting with FDA for prGCD
Protalix BioTherapeutics, Inc., PLX
Protalix BioTherapeutics, Inc., PLX
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Protalix BioTherapeutics, Inc. announced today that the Company 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. prGCD, the Company’s lead product candidate, is currently the subject of a pivotal Phase III clinical trial being conducted under the FDA’s Special Protocol Assessment (SPA) for the treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms.
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