But they have to submit the package first. That's where we are. I don't know what is left in their phase 3 trials.
Can you imagine the pure hell it must be to compile all that crap in a format the FDA wants? It makes my head hurt thinking about it. There are Companies that do that. I'd love to know if these egg heads are doing that in-house or have outsourced to a third party? That would be a good question for the Company. It would give a little more confidence.
The FDA will allow that kind of PR. Even all that shit is regulated and can give a new drug review a bump in the road. They have to be very careful what they put out.