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Post# of 426436
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Re: Danburydude post# 165524

Thursday, 12/06/2018 4:05:30 AM

Thursday, December 06, 2018 4:05:30 AM

Post# of 426436
Incorrect. They didn't say they needed to file in US to be able to later file in EU. They said the package need for EU will require the sNDA package to be completed as most info for EU package will come from sNDA package. They can literally file together. The timelines for approval may be different. OldYeller can confirm what I understood from the call.
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