Date:2/24/2010

erve the interests of physicians or patients who rely on this medicine to help them treat and deal with diabetes.

• Instead of reviewing the most recent and scientifically sound information, the Staff Report relies on a meta-analysis prepared by Dr. Nissen in 2007, an analysis which has been criticized widely, and contradicted by larger, more recent meta-analyses.

• In addition, the Staff Report suggests that GSK did not work to actively monitor the safety of Avandia or inform the FDA of its investigations.  That suggestion is fundamentally flawed and contradicted by a record of extensive, on-going interactions between GSK and the FDA, and the FDA's on-going review of Avandia in light of all the information available to the agency.  The Timeline included in the Staff Report omits key dates (included in the GSK White Paper) that demonstrate the on-going and open exchange of information that has characterized the FDA's active review of this medicine and GSK's efforts to provide data and respond to the agency's inquiries.

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