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Wyeth-Ayerst Rapamune

Executive Summary

Company anticipates rescheduling Antiviral Drugs Advisory Committee review for later this summer ("The Pink Sheet" May 3, In Brief). The May 26 Rapamune (sirolimus) review by the transplantation subcommittee was canceled because Wyeth has submitted additional data and intends to submit more data that the company wants FDA to analyze before it is presented to the committee. Rapamune's priority user fee goal date is in mid-June

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PS034190

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