Feb 16 (Reuters) - Discovery Laboratories Inc:
* Labs receives FDA guidance regarding pathway to potential Surfaxin(R)
approval
* Says will now focus on a pathway that would entail solely performing
additional preclinical work
* Says recently-received guidance from FDA advises that this model could be
used as an acceptable alternative
* FDA acknowledged that co had successfully demonstrated comparability of
clinical drug to to-be-marketed product
* Says believes a complete response could be submitted to the FDA in the first
quarter of 2011
((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780))
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* Labs receives FDA guidance regarding pathway to potential Surfaxin(R)
approval
* Says will now focus on a pathway that would entail solely performing
additional preclinical work
* Says recently-received guidance from FDA advises that this model could be
used as an acceptable alternative
* FDA acknowledged that co had successfully demonstrated comparability of
clinical drug to to-be-marketed product
* Says believes a complete response could be submitted to the FDA in the first
quarter of 2011
((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780))
(For more news, please click here) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.