Replies to post #53076 on Biotech Values

[DewDiligence]

> 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.

[DewDiligence]

VRUS addendum re SVR:

The buzz from VRUS about how great it is that they are testing for SVR in the phase-3 trials is bordering on propaganda, IMO. VRUS claims that Clevudine has a unique MoA that clears hepatocytes of HBV cccDNA, but they don’t explain what’s unique about it. I doubt that Clevudine’s MoA is significantly different from Tyzeka’s or Baraclude’s in this regard.

Moreover, I question whether Clevudine—or any nucleoside analog—can clear cccDNA so thoroughly that the disease will never come back.

Talking about SVR makes a good story because most investors in this sector are already familiar with the importance of SVR in HCV. Moreover, I give VRUS credit for designing an SVR test into the phase-3 trials as a secondary endpoint. But I question whether Clevudine is really any better than Tyzeka and Baraclude in clearing cccDNA and thereby providing a bona fide cure.