For all the technical and fundamental analysis supposedly on this board, no one is addressing political risk. This is an election year, the FDA has made a decision that will kill people. As the local papers, radio and TV pick it up, the advocacy groups get rolling, the national media begins to move, letters are sent to Members of Congress (all 435 are up in 2008) and Senators (33 are up in 2008, mostly Republicans ("Dear Congressman, the FDA has said my son has to die.") and eventually 60 Minutes picks it up, the FDA WILL move this forward on a much faster time frame.
Watch the members of the House Energy and Commerce Committee, the one with health care jurisdiction and the Government Op committee (Waxman D-CA) and you will see them get involved.
That is, we are in an election cycle, the actual election is November 08. The reality of today's politics is that Members of Congress run continually and same is true of the one third of the Senate up for election in the cycle.