Latest PDUFA date is March 6, 2012
>>WARRINGTON, Pa., Sept. 28, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - News) announced today that the U.S. Food and Drug Administration (FDA) has deemed "complete" the company's Complete Response for SURFAXIN® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA classified the review of the Complete Response as a Class 2 review and established March 6, 2012 as the target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for SURFAXIN.If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.
Discovery Labs will hold a conference call today at 3:00 PM EDT to provide an overview of the SURFAXIN Complete Response filed with the FDA.
Conference Call Details
A live webcast of the conference call, including a slide presentation, is available at us.lrd.yahoo.com**https%3A//us.reg.meeting-stream.com/surfaxin-update and www.discoverylabs.com. An archive of the webcast will be available on Discovery Labs Investor Relations web site for approximately 45 days.
For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the dial-in numbers are (866) 332-5218 (U.S.) or (706) 679-3237 (international). The passcode for the call is 11540927.
An audio replay of the conference call will be available two hours after the call's completion. The dial-in numbers for the replay are (855) 859-2056 or (404) 537-3406. The passcode for the replay is 11540927.<<
snip
They appear to have about a year of cash at present burn, but if they actually get approved before they make an offering, sell the approval after a few days, because they'll need the money to launch. My guess is that they finance at least one more time in the next 6 months. If one dares to play a potential run up to the PDUFA date, immediately after that financing might be a reasonable entry.
Cheers, Tuck |
