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Discovery Laboratories (DSCO) and FDA Meet to Clarify Limited Items in SURFAXIN® Approvable Letter

Discovery Laboratories, Inc. (NASDAQ: DSCO), a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases, held a teleconference on June 18, 2008, with the FDA. During this meeting, Discovery Labs discussed the remaining key items, originally identified on May 1, 2008 within the approvable letter from the FDA, in order for the company to potentially gain U.S. marketing approval of SURFAXIN® for the prevention of Respiratory Distress Syndrome (RDS) in premature babies.

Although the approvable letter from the FDA did not require any additional clinical trials to gain final approval for SURFAXIN®, one of the two items requires additional SURFAXIN® biological activity test data. These additional data will be correlated with results of previously conducted pre-clinical studies and will also be used to justify the acceptance criteria for the biological activity test.

The second remaining item involves justifying the proposed specifications for certain lipid-related impurities in the individual active pharmaceutical ingredients (APIs) that comprise SURFAXIN®. The company believes that it will be able to develop this information based on existing scientific literature. Discovery Labs is working to complete the activities related to finalizing these two items in order to submit its formal response to the approvable letter in September 2008.

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