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Re: genisi post# 73438

Thursday, 02/19/2009 5:03:47 PM

Thursday, February 19, 2009 5:03:47 PM

Post# of 257273

GENZ – CHMP issued a positive opinion on Myozyme's 4000L production facility.

Presumably, the 4000L Myozyme won’t have to be marketed as a brand new brand in the EU.

It looks like the FDA is being unduly cautious on this matter. It doesn’t help that a permanent FDA commissioner has not yet been appointed.


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