After a sit-down plan with the FDA regulators over the possibility of a limited trial, shares of Discovery Laboratories suddenly saw an upwards trend. This meeting will help Discovery Laboratories to get more information and data to overcome the outstanding primary concerns related to its respiratory drug Surfaxin.
The Food and Drug Administration has decided to have a meeting with Discovery Laboratories to resolve marketing approval issues of Surfaxin. Back in April, shares of Discovery Laboratories went tumbling down the index when FDA had raised questions about the biological activity test of Surfaxin drug.
Surfaxin is a synthetic surfactant therapy, for prevention of respiratory distress in premature infants. However, soon after the rejection call by FDA, stock analyst predicted that this situation was not healthy for Discovery Laboratories. FDA has given a written notification to Discovery Laboratories, Inc. (Nasdaq:DSCO) that a meeting has been scheduled for September 29, 2009 which will serve as a follow-up to the June 2, 2009 meeting and FDA’s April 17 Complete Response letter.
FDA will provide the options to Discovery Labs to resolve their primary issues related to Surfaxin which prevents RDS in premature infants. Additionally, Discovery Laboratories plan to talk about the limited clinical trials of Surfaxin, and to employ the fetal rabbit Biological Activity Test, that would help them address the key requirements for approval of Surfaxin.