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Re: amarinbullfromchicago post# 198887

Friday, 06/28/2019 8:36:17 AM

Friday, June 28, 2019 8:36:17 AM

Post# of 425664
There are two different meetings.

The mid-cycle review meeting is an FDA meeting that is part of the approval process. The EMA meeting is to discuss a pediatric waiver.

I believe the EMA Pediatric meeting agenda item is usually a preliminary discussion item, prior to the actual filing.
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