VRUS / Clevudine factoids:
>what would be the earliest [Clevudine] could move to market - 2009?
Late 2010 or (more likely) 2011.
>although it made it through to registration in Korea... what does it face in [FDA] P3 trials, that it did not face in S. Korea?<
The Korean trials included only 24 weeks of treatment and compared Clevudine to placebo. The total number of patients in the two Korean trials was only 337 (of which only 89 were e-negative).
The FDA phase-3 trials will treat patients for 48 weeks* and will compare Clevudine to Hepsera. The expected number of patients in the two FDA trials is 850-900.
>it appears there are high expectations for Clevudine...<
It’s hard to say because VRUS is below the radar screen of most investors. However, the enterprise value of VRUS is certainly out of whack with the EV of IDIX. Anyone who would consider VRUS a good buy at its current EV would have to be nuts not to think that IDIX was a great buy at its EV. Regards, Dew
*The primary efficacy endpoint will be based on an evaluation at 48 weeks, but patients will be treated for 72-96 weeks to assess safety and SVR.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
