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Biotech / Medical : Versicor (VERS) -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (67)	5/24/2004 11:25:51 AM
From: nigel bates	Read Replies (1) \| Respond to of 83

The PR (Did you listen to the cc ?) - Vicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin For the Treatment of Esophageal Candidiasis Requesting Additional Data Monday May 24, 2:00 am ET - Conference Call Scheduled for 8:30 a.m. EDT - KING OF PRUSSIA, Penn., May 24 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA). However, the letter indicated that the company's NDA submission for anidulafungin does not currently support a labeling claim for the initial treatment of esophageal candidiasis. In the letter, the FDA indicated that Vicuron could potentially achieve approval for anidulafungin upon the completion of Vicuron's ongoing Phase III clinical trial for the treatment of invasive candidiasis/candidemia or the completion of further clinical work in patients with candidal disease refractory to other treatments. "We intend to meet with the FDA to discuss all of our options with respect to the approval of anidulafungin as soon as possible, and intend to complete the Phase III trial in invasive candidiasis/candidemia by the end of this year," said George F. Horner III, President and CEO of Vicuron. "We also will take appropriate management action to reduce the expenses of the company in light of this delay."...