Discovery Laboratories, Inc. (DSCO) said it has submitted to the U.S. Food and Drug Administration its proposed protocol for a Surfaxin limited clinical trial. The protocol incorporates a clinical trial design that is primarily intended to assess a pharmacodynamic, or PD, response following Surfaxin administration in preterm infants with Respiratory Distress Syndrome, or RDS.
Discovery Labs proposed this trial design in response to a comment by the FDA that a limited clinical trial could potentially resolve the key remaining issue for approval of Surfaxin for the prevention of RDS in premature infants.
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