i do not no what happens next but if we get fda app this thing will take off, if they ask for more info, which i don't think is the case, there will be a big set back. i am not expecting that, as the fda had a shot at asking for all kinds of things in sept. and they did not.
You are correct, hence, that is why they were issued an approvable letter which highlighted those studies or data analysis necessary to obtain approval. As all will recall, they responded pretty quickly so it could not have been much.
It is also possible that an approval ahead of the pdufa date might occur, though doubtfull.
All in all, its good to be a long these next several weeks, particularly at these lower prices. All one needs to do is look back one year at the potential price we should be seeing. Risk reward ratio is very positive.