Good thing we've started working on this years ago:
Here is a bit more on the experience of the University of Iowa in obtaining an NDA approval just to provide a little insight into what is involved. The NDA process is not for the faint of heart. For the University of Iowa, it was a consuming four-year journey.
and unlike the professors at Iowa, we're not distracted by things such as seeking tenure. We only have one mission, which is to get 273 approved for something.