The US Food and Drug Administration (FDA) has notified Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) that it has extended the target date for approving the company treatment for Gaucher's disease by three months, to May 1, 2012. The original date for Protalix's New Drug Application for taliglucerase alfa Prescription Drug User Fee Act (PDUFA) (NDA) was February 1.
Protalix's share price fell 16.6% in premarket trading on the news to $5.16, giving a market cap of $400 million, and fell 16.2% by mid-afternoon on the TASE to NIS 19.42.
In November 2011 at the request of the FDA, Protalix submitted certain clinical information regarding taliglucerase alfa. Since the information was requested and provided within 90 days of the February 1, 2012 PDUFA goal date, the FDA has the option to extend the goal date by three months, in order to complete its review.
Protalix says that the three-month extension is the standard period granted, and that the FDA has not requested any additional data or informed the company about deficiency in the application for the drug.
Protalix president and CEO Dr. David Aviezer said, "We believe we have addressed the FDA's request. We look forward to working closely with the agency as it continues its review."
Published by Globes [online], Israel business news - www.globes-online.com - on December 6, 2011
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