LEXINGTON, Mass.--(BUSINESS WIRE)--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today provided an update regarding the status of its formal appeal to Steven Galson, M.D., director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), asking the CDER director to approve the company's novel blood-pool imaging agent Vasovist™ (gadofosveset trisodium injection). The appeal was submitted on February 28, 2007, and the company is currently in discussions with the Agency regarding the appeals process. Based on these discussions, it is now clear that the Agency’s decision-making process will extend beyond the originally anticipated 30-day period.
