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DewDiligence

05/02/13 9:25 PM

#160685 RE: BTH #160681

ARNA—They dropped their EU application.

That’s how things are done in genteel Europe. Before issuing a rejection, the EMA politely suggests that an applicant withdraw the application.

Of course, if the sponsor disagrees strongly with the rejection and intends to appeal (with a new set of rapporteurs), then there is no withdrawal. We saw this with PFE’s Xeljanz.