This would be an interesting outcome for shorts to get trapped! Can DVAX ask for a hearing or submit new data?
John Jenkins, M.D., director of CDER's Office of New Drugs, says, "It's often a combination of problems that prevent approval." Close communication with the FDA early on in a drug's development reduces the chance that an application will have to go through more than one cycle of review, he says. "But it's no guarantee."
The FDA outlines the justification for its decision in a complete response letter to the drug sponsor and CDER gives the sponsor a chance to meet with agency officials to discuss the deficiencies. At that point, the sponsor can ask for a hearing, correct any deficiencies and submit new information, or withdraw the application
I think the delay in DVAX announcing the FDA meeting is because they are working thorugh a very detailed complex solution that works....not holding back bad news and worrying about the stock price....for example didn't the advisory committee notes say that they would have approved DVAX for limited use but they applied for the widespread use?.....why does DVAX need to reapply then? Just provide the other studies to FDA and bring in the advisory committee vote count for that use......the only drawback to this argument is that FDA is a government agency and inherently beaurucratic.....but they are less so than other govt agencies....I am upgrading DVAX to a buy since I think they get some limited approval now without further studies and reapplying....they pull a rabbit out of the hat on everyone...imho