Thought this was just a matter of risk assessment and manufacturing BS....now they need more testing? Strange. It appears the delay will cost more than 1 year. Things will be fugly here tomorrow and over at AMLN too I am sure. Glad I was out after the Vivitrol approval, but I confess I thought this approval was basically in hand, and I am shocked....sorry to all of you. My advice is get out immediately at the open, even though it will likely be very ugly, just eat the loss and move on to greener pastures. This is DEAD money for a long time to come now for certain...the good news was last week apparantly, and this being the far more important decision, is very very very bad. I would not be surprised to see this head back towards single digits. This was really a must have approval, and mostly expected one.