I can't believe that Missling hasn't already been scoping out Canada as a second option... hence the consistent referral to "North America" for trial site location.
We have already been shamed internationally for individual healthcare, and our middle class is dwindling. A loss of dominance in drug research and approval would signal further breakdown of U.S. economic and political power.
The FDA is between a rock and a hard place. Damage control by the FDA IS the reason for the delay.