In the reread of images obtained from previous phase III studies, the company said that it has met all prespecified points agreed to with the U.S. Food and Drug Administration (FDA).
Epix plans to resubmit a new drug application (NDA) to the FDA for Vasovist in mid-2008. Vasovist currently is approved for marketing in 33 countries.
Epix reaches agreement with FDA over Vasovist, February 1, 2008
Epix to raise $16.3 million, November 12, 2007
Epix receives FDA response, June 19, 2007
Epix posts big Q1 loss, May 9, 2007
Epix chairman to retire, May 2, 2007
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