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Re: mskatiescarletohara post# 53076

Tuesday, 10/02/2007 9:58:56 PM

Tuesday, October 02, 2007 9:58:56 PM

Post# of 257314
> VRUS – Would the FDA consider the Bukwang studies as part of the marketing approval package here in the US?<

They already have in the sense that they allowed VRUS to proceed to phase-3 based on the Korean data. The FDA effectively considered the Korean trials to be successful phase-2b studies.

>Wonder how long it will take to enroll the pivotals? Any guidance from management, would one speculate a year?<

I think 1.5-2 years is more realistic given the size of the trials and the fact that Clevudine is similar to Tyzeka and Baraclude.

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