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 Biotech / Medical : Regeneron Pharmaceuticals

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From: Biotech Jim5/8/2012 12:28:54 PM
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Very interesting discussions on the Arcalyst FDA review for gout today, going into lunch break.

FDA now (~12:20 pm) backing down on the malignancy risk due to a question from a panel member to the FDA. The panel member wondered why the FDA used in its evaluation the insufficiently numbered PBO group in the Arcalyst study as comparator vs. to a population group used to evaluate the same oncology risk for TNF sequesterers. This standard has been on the table for the past 10 years. The FDA essentially then stated this was a discussion point, and if no issue the panel members can move on.
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