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Sunday, March 03, 2013 4:52:51 AM
I am nfortunately not an expert in drug approval, but what I know is that one of my client filled its US FDA request last July and received the approval last December (5 months review). The company submitted quite at the same time the EU request (last August) but this one has not been approved yet.
Based on the above, I will prefer that atrs decides to already submit its EU request this even if they are still discussing with some EU partners.
Hope this could help,
Garci
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