FDA Plays

[BarbaraT]

06:30 PLX Protalix BioTherapeutics receives from FDA a Complete Response Letter regarding co's New Drug Application for taliglucerase alfa for the treatment of Gaucher disease; FDA requests additional data (9.36 ) -Update-

The main questions raised by the FDA regarding the NDA relate to clinical and chemistry, manufacturing and controls. In the clinical section, the FDA requested additional data from the Company's switchover trial and long-term extension trial. At the time the NDA was submitted, full data from these trials was not available. In the CMC section, the FDA requested information regarding testing specifications and assay validation. "While we are disappointed by the receipt of the Complete Response Letter, we appreciate the FDA's efforts to complete the review of our NDA. We noted that the FDA did not request additional clinical studies. Moreover, the FDA inspected our manufacturing facilities finding them acceptable. FDA also did not identify any issues in its audit of our clinical sites..."