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OldYeller187

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OldYeller187

Re: None

Monday, 04/15/2019 5:30:54 PM

Monday, April 15, 2019 5:30:54 PM

Post# of 424759
Next EU submission deadline is June 3. Followed by July 1. Marketing applications are different in EU where there are set cutoff dates to submit. So, w/ the most recent submission deadline of April 8 passing, an EU submission tomorrow is the same as a submission on June 2. Either way EMA will not start review of those submissions until the deadline passes.

We can reasonably expect the EU filing to hit the June 3 deadline, w/ July 1 being a worst case scenario. I see no scenario where it would be any later.
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