Discovery Laboratories, Inc has received written notification from the US Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve as a follow-up to the June 2 meeting with the FDA and the FDA's April 17 Complete Response letter. The objective of this meeting is to define the options available to Discovery Labs to resolve the remaining primary issue that Discovery Labs must address to gain US marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.
At the upcoming September 29 meeting, Discovery Labs plans to discuss with the FDA a limited Surfaxin clinical trial design and whether conducting such trial, while simultaneously employing the fetal rabbit Biological Activity Test (BAT, a quality control and stability release test), could potentially address the key remaining requirement for Surfaxin approval. This approach was suggested by the FDA at the June 2 meeting as a way for Discovery Labs to increase the likelihood of gaining Surfaxin approval. In addition, Discovery Labs plans to review its ongoing quality improvement efforts, intended to further refine the BAT in accordance with Discovery Labs' continuing quality improvement initiatives, with the FDA.
Discovery Laboratories is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing.