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Re: ghmm post# 376

Wednesday, 10/21/2009 4:11:46 PM

Wednesday, October 21, 2009 4:11:46 PM

Post# of 3997
You were right on Replagal - "Shire announces plans to file a BLA with the FDA for REPLAGAL, its enzyme replacement therapy for Fabry disease, by the end of the year. The Company also announces that a treatment protocol for REPLAGAL, filed at the request of FDA, has been approved, and that it will support emergency IND requests. The early access program is being put in place in view of the announced supply restriction of the only currently marketed treatment for Fabry disease in the United States."
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