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Replies to #73438 on Biotech Values
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DewDiligence

02/19/09 5:03 PM

#73444 RE: genisi #73438

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.