Discovery Labs (DSCO) Receives Complete Response From FDA for Surfaxin for Prevention of RDS

April 20, 2009 7:49 AM EDT

Discovery Laboratories, Inc. (Nasdaq: DSCO) announced that, on April 17, 2009, it received a Complete Response letter from the U.S. FDA for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. In its letter, the FDA focuses primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before the Surfaxin application can be approved. Discovery Labs will host a conference call today at 9:00 AM. The call-in number for the conference call is 866-332-5218.

Discovery Labs believes that it has already submitted data necessary to respond to the questions raised by the FDA in the Complete Response letter and that its New Drug Application (NDA) is sufficient to gain marketing approval of Surfaxin. At this time, there are no questions regarding Discovery Labs' Phase 3 clinical trials, no comments regarding drug substance impurities, and no issues related to the manufacturing process for Surfaxin. Discovery Labs plans to seek an end of review meeting with the FDA to be scheduled as soon as possible. If the meeting is successful, Discovery Labs anticipates that Surfaxin may be approved in 2009.

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