reason why it is going up so much, page-14

In my view (but dyor) the fda approval is not a great hurdle. Enormous development has gone into the oraline product, it is already in the market (albeit only selling to law enforcement agencies) and is a device not a drug. With timing, I am expecting approval by mid Oct, if the filing is submitted by the end of this week (as anticipated) or next week. The statutory MAXIMUM assessment period is 90 days, but 30 or so days is more likely in this case.