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GSK Cervarix PDUFA Delay: Broad Label and Postmarket Plan Will Take Time

This article was originally published in The Pink Sheet Daily

Executive Summary

GlaxoSmithKline announced another delay Sept. 29 on the extended regulatory road for the HPV vaccine in the U.S.: but it may reflect good news. GSK needs a label that differentiates Cervarix from Gardasil. A quick review after the Sept. 9 advisory committee might have precluded the label it needs.
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