My prediction still maintains they will get the FDA approval. This company is pretty much solely pegged to this one product. All their efforts have been and will continue to be focused on getting approval. They will do whatever it takes to answer every one of the FDA's concerns. I am sure that as of today they are calling up all patients who participated in the study to obtain more data that might potentially be needed to answer concerns over data sufficiency and other stats that might be needed.
In the meantime, we've already got approval in Canada and working towards Europe and Australia. I think we will be just fine long term. I'm sitting on 5,000 shares right now. I will be smiling all the way to the bank in a year or so.