> 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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”