Discovery Labs Pulls Surfaxin Application In EU, Citing Manufacturing, Data Issues
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm may be required to conduct additional clinical trials comparing lucinactant to the leading EU surfactant, Curosurf.
You may also be interested in...
Discovery Labs Anticipates Surfaxin Approval In 2008 For Respiratory Distress Syndrome
Firm is resolving outstanding manufacturing issues with the synthetic surfactant, with plans to submit six-month stability data in a “complete response” to FDA.
Discovery Labs Anticipates Surfaxin Approval In 2008 For Respiratory Distress Syndrome
Firm is resolving outstanding manufacturing issues with the synthetic surfactant, with plans to submit six-month stability data in a “complete response” to FDA.
Discovery Labs’ Second Surfaxin Approvable Letter Highlights CMC Concerns
The company does not foresee the need for additional clinical trials.