The FDA has approached Protalix BioTherapeutics for treatment protocol of its lead drug candidate for patients with Gaucher disease. It requires that treatment protocols be submitted for a drug that has not yet been approved for marketing but is the subject of clinical development for a serious or life threatening disease for which no comparable or satisfactory alternative drug or therapy is available. The FDA is attempting to reduce the effect of an expected shortage of the drug, Cerezyme [imiglucerase]while one of Genzyme"s facilities has been shutdown due to contamination concerns.