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CMO Henry Fuchs stated that this was due to, "conversations with opinion leaders as well as from the study of the regulatory landscape about the requirements for registration support. And as I think I've mentioned before, what's clear is that a switching study would be required to support the registration of 701. And a switching study is something that we can start relatively readily, we believe." Improvements in BioMarin's manufacturing capabilities related to BMN 701 are also leading to an accelerated clinical trial schedule.

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