Discovery Laboratories is signaling investors to hang on for a few weeks more. After seeing its stock price go into meltdown mode Friday on the FDA's third approvable letter for Surfaxin [1], Discovery execs announced that they believe they can respond to the agency in six to eight weeks and may get another review in as few as 60 days.
"Discovery Labs firmly believes that this recent approvable letter reflects notable progress towards gaining FDA approval for Surfaxin," the company said on Monday. There is no requirement for a new trial of the drug, which treats respiratory distress syndrome in premature babies. Discovery Labs may be making an impact. Its stock price climbed more than 10 percent this morning.
- check out the Discovery release [2]
Related Articles:
FDA delays Discovery Labs approval [1]
Discovery Labs to raise $25M [3]
Discovery Labs to explore "strategic alternatives" [4]
Discovery Labs pulls marketing app for Surfaxin [5]
Discovery Labs shares sink on data demand [6]
Links:
[1] http://www.fiercebiotech.com/story/fda-delays-discovery-labs-approval/2008-05-02
[2] http://www.fiercebiotech.com/press-releases/discovery-labs-provides-guidance-fda-approvable-letter-surfaxin-rds
[3] http://www.fiercebiotech.com/story/discovery-labs-raise-25m/2007-12-07
[4] http://www.fiercebiotech.com/story/discovery-labs-to-explore-strategic-alternatives/2006-06-20
[5] http://www.fiercebiotech.com/story/discovery-labs-pulls-marketing-app-for-surfaxin/2006-06-07
[6] http://www.fiercebiotech.com/story/discovery-labs-shares-sink-on-data-demand/2006-04-05