Yes, it doesn't sound like the EMA is going to pull Omacor in Q1'19 like Michael Yee was forecasting on his analyst news timeline based off the 12/14/18 EMA CHMP opinion. Maybe an EMA final decision will be in Q3'19?
- Its now being reported that an appeal request was filed with the CHMP to re-examine the post-MI indication.
- The request will stop the process and the EMA will have to seat a new rapporteur/co-rapporteur to the case to review old/new information.
- New CHMP opinion expected on the appeal in Q2'19.