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Burn Sanderson

10/14/19 10:39 PM

#219278 RE: Mr1979 #219274

Because in EU/EMA you apply for accelerated assessment in advance of the submission. It’s different than US.

VuBru

10/15/19 9:38 AM

#219390 RE: Mr1979 #219274

Mr - I believe the EMA determines priority review before submission of the full application.