EPIX Pharmaceuticals (EPIX) Files Appeal With FDA Regarding Vasovist(TM) Approvable Letters
7/5/2006 2:58:21 PM
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 30, 2006--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX - News), a developer of innovative pharmaceuticals for magnetic resonance imaging (MRI) which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that it has submitted a formal appeal to the U.S. Food and Drug Administration (FDA) asking the FDA to approve the Company's novel blood-pool imaging agent Vasovist(TM). The Company submitted the appeal to the Office of New Drugs of the FDA and has asked that an Advisory Committee be utilized as part of the appeal process. The Company expects that the Office of New Drugs will respond to the Company's submission within approximately 30 days, although any decision could be delayed if the Office of New Drugs grants the Company's request for an Advisory Committee.