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Re: jb_118 post# 100123

Thursday, 07/29/2010 10:58:06 PM

Thursday, July 29, 2010 10:58:06 PM

Post# of 257579
Enzyme is going to be approved only after clinical trial. Both Shire and Plotalix had to go through clinical trials to get similar enzyme to Cerezyme approved. Most importantly, GENZ's own Myozyme was considered as a different product by FDA by merely changing production from 160L to 4000L bioreactor, the later is called Lumizyme.

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