January 9, 2012
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2:57Now PlayingStan Crooke says the FDA could delay the development of cholesterol medicines that target the PCSK9 gene.
Developers of PCSK9 drugs say they do not share Crooke's concern. Regeneron confirmed the receipt of a letter but said the concerns were "completely standard and typical of the drug development process." Amgen said its interactions with the FDA have been "productive and positive." The FDA said it cannot comment on products under review, and Pfizer did not return calls requesting comment.
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