EMA flexibility

as on ymb :

Shares of Amicus Therapeutics Inc. jumped after a European regulatory panel recommended its drug for a rare genetic disorder
Here's an example of moving forward in EU after being asked by the FDA for more information.
13 months and counting to react to partial clinical hold.

This is a prime example of the EMA showing more flexibility than FDA with orphan disease drugs. In October 2015 FDA asked FOLD for more information after their Phase 3. And yesterday EMA approved FOLD's marketing authorization for the same drug. As we have said many time here, the EMA exhibits more flexibility especially for orphan diseases. This will likely be similar to what Prana will see with the EMA for PBT2.