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Replies to #73844 on Biotech Values
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drbio45

03/02/09 7:05 PM

#73849 RE: DewDiligence #73844

FDA delays Lumizyme (Myozyme 2000L process) approval, citing CMC issues


They said on the conference call that they recieved the complete response letter on Friday. I know they have 3 business days to make announcements about material news but this news should have been released Friday after hours, but certainly before market open this morning.
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genisi

03/03/09 12:48 PM

#73875 RE: DewDiligence #73844

The Allston facility is also where Cerezyme and Fabrazyme are being produced. Wonder if that unexpected warning letter means more troubles.