John Carroll - Juno and FDA screwed up. People died. What now?, page-4

And unfortunately the Juno debacle will make it MORE difficult for Prana and others to make their way through the process because the FDA will become even more cautious with the little biotechs--not wanting to be seen making the same mistake twice.

The unusual Sarepta decision earlier this year has probably made things more difficult for Prana as well because the FDA does not want to appear to have "gone soft" listening to patient advocacy groups and financially-strapped companies.

Seems like Europe is definitely the way to go.