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Post# of 426647
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SonamKapoor

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SonamKapoor

Re: sts66 post# 167281

Wednesday, 12/26/2018 12:03:38 PM

Wednesday, December 26, 2018 12:03:38 PM

Post# of 426647
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.


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