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Biotech / Medical : dsco Discovery Laboratories
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From: tnsaf5/29/2008 11:13:22 AM
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7:01AM Discovery Labs and FDA to meet on June 18, 2008 to clarify limited items in SURFAXIN approvable letter (DSCO) 1.78 : Co announces it has received written notification from the FDA that a meeting has been scheduled for June 18, 2008 via teleconference. This meeting is intended to confirm with the FDA Discovery Labs' approach to address the limited key remaining items necessary to gain U.S. marketing approval of SURFAXIN for the prevention of R.D.S in premature infants. On May 1, 2008, Discovery Labs received an Approvable Letter from the FDA for SURFAXIN that reflected notable progress towards gaining FDA approval.
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