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GSK timeframe for Cervarix launch uncertain

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline intends to respond to FDA's "complete response" letter for its human papilloma virus vaccine Cervarix in the second quarter, CEO JP Garnier says during a year-end earnings call Feb. 7. But, he added, "I don't know when the timing of the launch is going to be because frankly the FDA is not going to give us an answer for quite a while, and they would want to go in front of the advisory committee first." GSK continues to prepare to compete with Merck's HPV vaccine Gardasil; GSK is conducting a head-to-head trial of the vaccines and expects to release data later this year...

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