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Biotech / Medical : dsco Discovery Laboratories

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From: Arthur Radley	9/30/2009 8:44:09 AM
	of 318

Talk about the rise of the Phoenix one more time.......getting rid of the CEO has done wonders for this company. UPDATE 1-Discovery Labs says FDA agrees on lung drug program Wed Sep 30, 2009 8:17am EDT * Says co, FDA establish path for potential Surfaxin approval * Says to submit final protocol to FDA in mid-Q4 * Shares rise 61 pct pre-market Sept 30 (Reuters) - Discovery Laboratories Inc (DSCO.O: Quote, Profile, Research, Stock Buzz) said U.S. health regulators agreed upon its proposed program to resolve questions about the company's experimental lung drug, sending its shares up 61 percent. Discovery said the U.S. Food and Drug Administration at a meeting indicated the company's proposed program to optimize and validate a quality-control test was reasonable. The company said it expects to finalize a protocol and submit it to the FDA in mid-fourth quarter. The drug, Surfaxin, is being developed for the prevention of respiratory distress syndrome in premature infants. In April, the FDA declined to approve the drug, raising questions on certain aspects of a biological activity test. Shares of the company rose as much as 61 percent to $1.79 in pre-market trade. They had closed at $1.11 Tuesday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Vinu Pilakkott) ((anuradha.ramanathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800: Reuters Messaging: anuradha.ramanathan.reuters.com@reuters.net))

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