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HDGabor

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HDGabor

Re: OldYeller187 post# 165462

Wednesday, 12/05/2018 7:49:03 PM

Wednesday, December 05, 2018 7:49:03 PM

Post# of 426489
O-

And of course we can hope that the Initial MAA is filed in EU around the same time as the US sNDA. Approval of that would be projected ~ 1 yr from filing, so some time in 1Q 2020.

Do you see any chance for centralised procedure (with European Medicines Agency) and approval within 277 days (217 days in case of accelerated approval) in the EU?

Best,
G

"There are some things money can't buy. For everything else, there's AMRN."

Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for

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