Rochester, NY 7/15/2009 4:07:37 PM
DSCO - DSCO: "a significant hurdle for approval." Drug Features
Discovery Laboratories, Inc.
Discovery Laboratories, Inc., DSCO
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Discovery Laboratories said late Wednesday that its lead drug candidate, a treatment for respiratory distress syndrome in premature infants called Surfaxin, faces “a significant hurdle for approval.”The news sent Discovery shares down by 52 percent Thursday, to 50 cents.Wednesday’s announcement was tied to the Warrington, Pa.-based company’s disclosure that it had received written minutes of its June 2 meeting with the Food and Drug Administration. At the meeting, according to Discovery, the FDA said it will “apply a newly-defined standard to determine whether Discovery Labs has adequately demonstrated comparability” of Surfaxin used in clinical tries to Surfaxin intended for commercial use. Surfaxin is meant to imitate the function of the lung’s natural surfactants, fluids with a soapy consistency that reduce friction and help breathing.
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