Biotech Values

[DewDiligence]

A new FDA mandate limits HCV monotherapy studies to a duration of three days because measurable resistance has emerged with some HCV compounds as early as day four. (Previously, the typical length of HCV monotherapy studies was 7-14 days.)

From now on, HCV drug candidates will advance into combination studies with peg-ifn and ribavirin following completion of a 3-day monotherapy study. (Source: today’s IDIX CC)