Discovery Labs’ Second Surfaxin Approvable Letter Highlights CMC Concerns
This article was originally published in The Pink Sheet Daily
Executive Summary
The company does not foresee the need for additional clinical trials.
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Discovery Labs has received a second FDA "approvable" letter for its premature infant respiratory distress syndrome treatment Surfaxin (lucinactant) requesting information on the chemistry, manufacturing and controls section of the firm's 2004 NDA. "The information in the letter predominantly involves the further tightening of active ingredients and drug product specifications and the related controls thereof," Discovery Labs CEO Robert Capetola said during a conference call April 5. The company's first approvable letter for the surfactant - received in February 2005 - also focused on manufacturing issues (1 (Also see "Discovery Labs Continues Dialogue With FDA On Surfaxin Surfactant" - Pink Sheet, 19 Aug, 2005.)). The company does not anticipate the need to conduct additional trials. "We do not have any clinical or biostatistical questions related to trials, or even any hint that any new trials will need to be conducted," Capetola said. Discovery Labs is currently arranging a meeting with FDA to establish the conditions necessary for approval. "We feel that we're rounding third base and coming into home," Capetola said. "If we can get this clarity that we need with the FDA, we're going to be there." -Mary Bruce |