I think tspt will come up with some way of addressing the FDA concerns. Probably with a combination of clever packaging as well as a limited indication. It seems like FDA wants TSPT to figure out which subgroup has the highest next day effect and then contra indicate them. Even with a limited label, they will get off label prescriptions. But these studies and analysis will take time and money. My guess is another 1 to 1.5 years. Government now adays just doesn't trust people to take of themselves. They want to control every aspect of people's lives. It's out of hand.