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Discovery Labs targets 3Q for Surfaxin FDA filing
Discovery Laboratories sets early 3rd-qtr deadline to file FDA complete response on Surfaxin
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Companies:
o Discovery Laboratories, Inc.

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On Tuesday February 1, 2011, 8:45 am EST

WARRINGTON, Pa. (AP) -- Discovery Laboratories Inc. said Tuesday it aims to file early in the third quarter a complete response to the Food and Drug Administration for its drug Surfaxin.

Surfaxin aims to prevent respiratory distress syndrome in premature infants. The Warrington, Pa., company said it believes a key remaining step it must complete is to satisfy regulators about the final validation of a preclinical fetal rabbit biologic activity test, an important quality control release and stability test for Surfaxin.

Preclinical trials do not involve humans and are shorter and less expensive than trials involving people.

The FDA has been reviewing Surfaxin since 2006, but it has not approved the drug because of concerns about the test used to determine Surfaxin's shelf life, as well as manufacturing issues.

A third-quarter filing could lead to an FDA decision on approval early in the first quarter of next year, Discovery said.

Source:
http://finance.yahoo.com/news/Discovery-Labs-targets-3Q-for-apf-2285567039.html?x=0&.v=1