osinod
Banned
questa è invece la news che potrebbe rendere molto appetibile dsco:
Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval Conference Call Scheduled for Today At 11:00 AM EST WARRINGTON, Pa., Jan. 22, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq
SCO) announced today that it has received guidance from the U.S. Food and Drug Administration (FDA) in a recent meeting regarding the key remaining steps necessary for potential approval of Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The guidance provides the clarity and the defined pathway that Discovery believes is necessary to address key remaining issues identified in the April 2006 FDA Approvable Letter. Discovery anticipates filing its formal response to the Approvable Letter in September or October 2007, followed by a six-month review cycle by the FDA for potential approval of its New Drug Application (NDA) for Surfaxin. The guidance was based on a face-to-face meeting with the FDA on December 21, 2006 as well as the FDA's review of the meeting briefing package submitted by Discovery on September 28, 2006
Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval Conference Call Scheduled for Today At 11:00 AM EST WARRINGTON, Pa., Jan. 22, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq
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