Discovery Labs (DSCO) Responds to FDA Over SURFAXIN; Plans Q4 Commercialization
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Discovery Laboratories, Inc. (Nasdaq: DSCO) announced that on June 7, 2013 it submitted a response to the U.S. Food and Drug Administration's (FDA) recent correspondence relating to Discovery Labs' recently updated product specifications for SURFAXIN. Discovery Labs expects that the FDA may take up to four months to review the information provided. If its plan is successful and the FDA agrees with the response, Discovery Labs expects to proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013.
In the third quarter of 2012, during a routine review of the results and processes related to the analytical testing and quality control of SURFAXIN drug product, Discovery Labs determined that one of its analytical chemistry methods used to assess SURFAXIN drug product conformance to specifications required improvement and that an update to product specifications was necessary. The Company proactively communicated these findings to the FDA, improved and revalidated the analytical chemistry method, and submitted updated product specifications to the FDA. Subsequently, the FDA requested information and provided recommendations intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method. Discovery Labs has now responded to the FDA's request.
Improvement of the method and the proposed change in SURFAXIN product specifications is expected to have no impact on Discovery Labs' development programs, including AEROSURF®. The AEROSURF program currently remains on track for the initiation of phase 2 clinical program in the fourth quarter of 2013.
In the third quarter of 2012, during a routine review of the results and processes related to the analytical testing and quality control of SURFAXIN drug product, Discovery Labs determined that one of its analytical chemistry methods used to assess SURFAXIN drug product conformance to specifications required improvement and that an update to product specifications was necessary. The Company proactively communicated these findings to the FDA, improved and revalidated the analytical chemistry method, and submitted updated product specifications to the FDA. Subsequently, the FDA requested information and provided recommendations intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method. Discovery Labs has now responded to the FDA's request.
Improvement of the method and the proposed change in SURFAXIN product specifications is expected to have no impact on Discovery Labs' development programs, including AEROSURF®. The AEROSURF program currently remains on track for the initiation of phase 2 clinical program in the fourth quarter of 2013.
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