susmoose Share Thursday, December 16, 2010 11:03:30 AM
Re: None Post # of 366034
UPDATE 1-Discovery Labs says drug likely to get FDA nod
Wed Dec 16,2011 11:00EST Discovery Laboratories, Inc.
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Discovery Labs, commented, "We are pleased with the guidance received and outcomes obtained from our interaction with the FDA. This guidance provides a viable option for Surfaxin and meaningfully supports advancing our pipeline initiatives to potentially address a broad range of respiratory diseases such as RDS, Acute Respiratory Failure, Acute Lung Injury and Cystic Fibrosis. We look forward to continued productive dialogue with the FDA.
"Our most advanced programs from our KL4 surfactant pipeline, Surfaxin, Surfaxin LS(TM) and Aerosurf(R), have the potential to greatly improve the management of RDS and to redefine the RDS market. Our top priority is to secure strategic alliance partners and access capital to advance our pipeline and build shareholder value. As we move forward, we will take into account further interaction with the FDA and make strategic assessment, together with existing and potential new partners to determine the appropriate level and timing of Surfaxin investment and to maximize the value of our KL4 pipeline for RDS."
Accordingly, Discovery Labs initiated a series of side-by-side studies employing both the preterm lamb model of RDS and the BAT and believes that the correlated results demonstrate comparability and support approval of Surfaxin.
Our goal as a company is to bring life changes into the medical community,and to bring profitabilty back to our shareholders. Rating :