Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin
Press Release Source: Discovery Laboratories
Monday August 15, 7:00 am ET
WARRINGTON, Pa., Aug. 15, 2005 (PRIMEZONE) -- Discovery Laboratories, Inc. (NasdaqNM:DSCO - News), announces that it has received a preliminary communication from the U.S. Food and Drug Administration (FDA) indicating that the Company's previously submitted Response Letter is not considered complete at this time. The FDA notified Discovery that it will provide, later this week, its official written communication regarding select matters for which the FDA may be requesting additional information. The Company previously submitted its Response Letter to the FDA's Approvable Letter for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants on July 29, 2005.
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Robert J. Capetola, Ph.D., President and CEO of Discovery, commented, ``The response we recently submitted to the FDA's Approvable Letter for Surfaxin was encyclopedic and comprehensive. Based upon the thoroughness of our Response Letter, we are optimistic that the FDA's issues will center on a few select items that are capable of being addressed in an as timely and efficient manner as possible. Of course, we will have greater clarity on these matters once we have received and fully assessed the FDA's official communication which we expect later this week. At that time, we anticipate holding a conference call to communicate more detailed information with our shareholders. We believe that our relationship with the FDA has always been collaborative and very productive. We anticipate prompt discussions with the FDA and moving forward to finalize a complete response as quickly as possible.''
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