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Re: OakesCS post# 81739

Saturday, 08/01/2009 11:54:51 AM

Saturday, August 01, 2009 11:54:51 AM

Post# of 252390
GENZ - the Allston plant saga

GENZ has restarted production of Fabrazyme and Cerezyme at the Allston plant. Will they be allowed to sell that production when they eventually satisfy the FDA?

Key word in your question is 'satisfy', meaning - will the FDA be satisfied with Cerezyme and Fabrazyme that were produced before reinspection? I think it will cause the reinspection is probably more about the manufacturing issue detailed in a warning letter that was issued in Feb and not about the viral contamination. Key question is - when. Of course GENZ will eventually get these issues taken care of, but meanwhile, they are losing time, money, and credibility and competitors are enjoying a tailwind.

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