isn't it funny that CHMP and FDA lokking at medicine differently?
Their guidelines are slightly different. On one checklist they make it and on the other, they don't. Simple as that. If ARNA needs to raise their efficacy for EU and they know that they can't, then they are done. Pull the application and move on.
i thought usually FDA was more demanding and critical
Actually the EU has very similar diet drug requirement but they expect more efficacy