PLX - Protalix receives PDUFA extension for NDA for taliglucerase
Protalix BioTherapeutics announced that it received notification from the FDA that the FDA has extended the Prescription Drug User Fee Act, or PDUFA, 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.