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Re: BioBS2012 post# 184808

Monday, 04/01/2019 7:22:08 AM

Monday, April 01, 2019 7:22:08 AM

Post# of 425255
What additional information requirements are you referencing? There is actually no requirement for patient data listings/CRFs for EU, which actually makes the EU dossier much simpler compared to US from that perspective.

Yes, US submission is an sNDA, where EU filing is an original application...this is a factor, but the EU filing can simply leverage this previously submitted info from the US applications in the EU dossier. So yes, it’s a consideration, but not a big deal. It’s all about content reuse.

I think your projection of 2 more months is a good one. And it could be much sooner.
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