Despite an EU approval just a couple of days ago -- the US FDA has declared the Schering anesthesia drug Bridion®, or sugammadex, "not approvable". I'll have much more shortly (including a shiny original graphic -- DONE! -- see at right), but here is the Marketwatch story. Off
9 now 7.5 percent in NASDAQ pre-market trading (small volumes, though, to be fair). Wow.
[I'm tempted to say "told ya' so" -- with my earlier prediction for FDA approval of sugammadex coming in 2009 -- but I won't. He~He!]
It seems the FDA wants additional data on allergic reactions -- and while that doesn't directly point to concerns about efficacy -- it does portend a rather substantial additional delay. As I mentioned last night -- it seems deficient data sets out of Schering are an emerging theme -- first from two Congressional Committee Chairs, now FDA. So much for that "bump" to Schering EPS in 2008 -- or even 2009(?). That would-be $600 million market just became about $200 million, for the foreseeable future. Said another way, the 2.4 cents in EPS pick-up I posited two days ago just became one shiny penny. Just one cent of EPS, for the foreseeable future. Ouch.
Friday, August 1, 2008
Posted by condor at 7:31 AM