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Firm Knew of FDA Concerns in Advance

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Reuters

Transkaryotic Therapies Inc. said it knew about concerns held by the Food and Drug Administration with its lead drug, Replagal, before Sept. 27--at least three days before it released the news to the public.

The company did not reveal that the regulatory agency had raised doubts that the drug significantly reduced pain in patients with Fabry’s disease, a rare and often fatal genetic disorder.

Transkaryotic shares fell 31 cents to $12.40 on Nasdaq.

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