ARTICLE | Company News
Discovery Labs gains on Surfaxin update
October 2, 2007 1:27 AM UTC
DSCO gained $0.47 (17%) to $3.16 on Monday after the company said it remains on track to submit a response this month to an April 2006 approvable letter for Surfaxin lucinactant to prevent respiratory distress syndrome (RDS) in premature infants. The company expects a six-month review for the lung surfactant. DSCO also said that new process validation production batches of Surfaxin have demonstrated acceptable stability at six months. It plans to submit the data and address CMC issues identified in the April 2006 approvable letter in its response to FDA. ...