I thought this was an interesting article in regard to FDA hold...

I thought this  was an interesting article in regard to FDA hold on PBT

Money quote

Senators Ted Cruz, R-Texas, and Mike Lee, R-Utah, recently introduced the RESULT Act ("Reciprocity Ensures Streamlined Use of Lifesaving Treatments"). Under the legislation, drugs and medical devices that are approved in certain other countries could be quickly approved in the United States as well.

In line with such insight, the Cruz-Lee reform would bust the FDA's monopoly on giving permission. The European Medicines Agency (EMA), for example, could instead give effective permission in the U.S. market.


http://www.realclearpolicy.com/blog/2016/01/13/a_simple_way_to_speed_drug_approvals_1517.html

Regards
Chris