Biotech Values

[DewDiligence]

Was this [change from SVR24 to SVR12] brought on at Medivir's request or mandated by the FDA itself? If it's the former, presumably a big deal in a positive way in that it speaks volumes to Medivir's confidence in TMC435? If it's the latter, possibly a big deal in a negative way in that this is a higher hurdle to pass?

SVR12 is a lower hurdle than SVR24, not a higher one.

As noted in #msg-69022802 and #msg-69024551, the change from SVR24 to SVR12 was overdue. Now that HCV assays have a lower level of detection than they did in the old days, one can be more confident that a patient who tests virus-free at the end of treatment (or earlier) actually is virus-free. This, combined with the superior efficacy of newer HCV regimens and the response-guided protocols used in virtually all HCV pivotal trials, makes a relapse more than 12 weeks after the end of treatment much less likely than in the old days.