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Re: attilathehunt post# 15142

Saturday, 03/11/2017 12:49:07 PM

Saturday, March 11, 2017 12:49:07 PM

Post# of 108192
Got it, thanks for the clarification. One of EMA's great strengths (relative to FDA) is transparency. Once they file, expect 5 to 7 months before CHMP recommendation and up to 2 additional months before EC approval. Maybe a little faster if they have orphan drug status or they can convince the agency to give conditional approval. We should be able to follow along on the EMA website as the meetings happen and the agendas are published.

But nothing happens until they file the MAA, and according to their 1/7/17 PR, we should expect that in 2H17.

Anyway, looking forward to Tuesday and any information that might accelerate that timeline!
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