FDA kills off Amicus’ 2018 accelerated approval plan

FDA kills off Amicus’ 2018 accelerated approval plan

Source: 
Fierce Biotech
snippet: 

The FDA has told Amicus Therapeutics it cannot file for accelerated approval of Pompe disease drug AT-GAA using its existing data. Amicus must now continue adding to its existing phase 1/2 data with a view to sitting down again with the agency next year.