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Re: ThomasS post# 5440

Thursday, 11/01/2007 11:39:31 PM

Thursday, November 01, 2007 11:39:31 PM

Post# of 19309
>Canada: Do they just accept FDA and/or EU data for approval via some mutual recognition process?<

Canada has its own full-fledged review process.

It is not necessary to have Canadian trial sites to get Canadian approval, but it may help in certain instnaces. Leo has a Canadian trial site in the phase-2 DIC study in progress.

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