Wow...DSCO at .95 now...not sure I understand why???...but here is the news...Discovery Labs Receives Complete Response From FDA for Surfaxin for Prevention of RDS; FDA focused on whether the BAT can adequately distinguish change in Surfaxin drug (1.80 ) : Co announces that on April 17, 2009, it received a Complete Response letter from the U.S. Food and Drug Administration for Surfaxin for the prevention of Respiratory Distress Syndrome in premature infants. In its Complete Response letter, the FDA focused on whether the BAT can adequately distinguish change in Surfaxin drug product over time and whether Discovery Labs has adequately validated the BAT and determined its final acceptance criteria. Validation of the BAT would confirm the comparability of Surfaxin drug product used in the clinical trials to the commercial Surfaxin drug product. Discovery Labs believes that data already submitted to the FDA support the comparability of Surfaxin clinical drug product to commercial Surfaxin drug product and demonstrate that the BAT can adequately distinguish change in Surfaxin over time and is an appropriate test for monitoring Surfaxin biological activity throughout its shelf-life. In the Complete Response letter, the FDA also indicated that Discovery Labs needs to tighten one drug product specification, which can be readily implemented. The Complete Response letter also contained routine requests to update safety and other information in the NDA as well as information requests about certain regulatory matters. In addition, the FDA has approved the trade name Surfaxin. Discovery Labs will host a conference call today at 9:00 AM.
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