After hearing that the FDA is demanding more information on Cervarix before it can be approved, analysts are estimating that GlaxoSmithKline could face delays of up to two years in launching the therapy in the U.S. That's a significant blow for the UK drug maker, which had been hoping to go head-to-head against Merck's Gardasil and replenish sales in the U.S.--which have been hit hard by dwindling sales of Avandia. Adding to the confusion and uncertainty, Glaxo declined to spell out exactly what the FDA is looking for. That could mean anything from a short delay of a few months to answer technical questions to a serious time lag as researchers harvest more data from ongoing clinical trials of the vaccine.
- see GSK's release on the setback
- here's the report on the delay from The Guardian
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