ABBV/ENTA’s guidance is an early 2015 EU launch of the 3-DAA HCV regimen, based on the EMA’s conducting an Accelerated Assessment* of the MAA.
ENTA's $20M milestone from the MAA submission matches the $20M milestone ENTA receved from ABBV on the NDA submission to the FDA in April. ENTA will receive an additional $155M in milestones from regulatory approvals of the 3-DAA regimen; all but a tiny fraction of this $155M is attributable to approvals in the US and EU (#msg-100940717).
*EMA’s Accelerated Assessment is similar to FDA priority review, but it lacks a firm deadline due to stoppages in the review clock while the applicant is responding to formal written questions from the EMA.
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