I have to cut my losses, going to hold 5 million shares, and sell the rest. I gave this a shot ,and lost.  I am not going to hold this another 6-8 months, and still not get approved. in my opinion, the fda chances have greatly diminished after that recent news. I made my decision after much contemplation, was not an easy decision, but pps is going down to the teens, and im not sticking around for it.
good luck longs, I wish you all the best