* Says on track to complete preclinical program
* To file complete response to FDA in Q1, 2011
May 19 (Reuters) - Drug developer Discovery Laboratories Inc said it completed the revalidation of quality control and stability test of its drug to treat respiratory illness in infants.
In April, the U.S. Food and Drug Administration declined to approve the drug, Surfaxin, raising questions on certain aspects of a biological activity test (BAT) -- a quality control stability and release test.
'The optimization and successful revalidation of the BAT is a key milestone in Discovery Labs' plans to resolve the sole remaining Chemistry, Manufacturing & Control issue,' the company said in a statement.
The BAT optimization and recently completed revalidation has taken into account FDA suggestions and comments, Discovery said.
The company said it remains on track to complete the preclinical program and submit its complete response to the FDA in the first quarter of 2011.
Shares of the company closed at $0.49 Tuesday on Nasdaq.
(Reporting by Anand Basu in Bangalore; Editing by Don Sebastian) Keywords: DISCOVERYLABORATORIES/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:anand.basu.reuters.com@reuters.net) 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.
* To file complete response to FDA in Q1, 2011
May 19 (Reuters) - Drug developer Discovery Laboratories Inc said it completed the revalidation of quality control and stability test of its drug to treat respiratory illness in infants.
In April, the U.S. Food and Drug Administration declined to approve the drug, Surfaxin, raising questions on certain aspects of a biological activity test (BAT) -- a quality control stability and release test.
'The optimization and successful revalidation of the BAT is a key milestone in Discovery Labs' plans to resolve the sole remaining Chemistry, Manufacturing & Control issue,' the company said in a statement.
The BAT optimization and recently completed revalidation has taken into account FDA suggestions and comments, Discovery said.
The company said it remains on track to complete the preclinical program and submit its complete response to the FDA in the first quarter of 2011.
Shares of the company closed at $0.49 Tuesday on Nasdaq.
(Reporting by Anand Basu in Bangalore; Editing by Don Sebastian) Keywords: DISCOVERYLABORATORIES/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:anand.basu.reuters.com@reuters.net) 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.
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