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Wednesday, 01/16/2013 11:03:23 AM

Wednesday, January 16, 2013 11:03:23 AM

Post# of 12
Trading halted @$12 then jumped to $14 despite delayed PDUFA. Hyperion notified that FDA will not meet the PDUFA action date for Ravicti (HPTX) 12.00 : Co said that the U.S. Food and Drug Administration (FDA) has advised it not to expect a final action by the Prescription Drug User Fee Act action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application for Ravicti (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders.