Biotech Values

[DewDiligence]

Re: FDA policy on phase-1b/2a trials in HCV

I imagine that scenario is less likely with IDX320 though since it's a PI whereas IDX184 is a nuke. (I think PIs tend to show their potency more quickly than the nukes, right?)

Yes, they do; however, you don’t get much useful information from 3 days of monotherapy dosing even with a PI.

3-day monotherapy studies of HCV agents are silly, IMO, but they are mandated by the FDA’s undue fear of inducing viral resistance. I think the FDA should get rid of 3-day monotherapy studies by using one of two approaches:

a) Allowing 7-14 day monotherapy studies in HCV patients; or

b) Dispensing altogether with monotherapy studies in HCV patients and allowing companies to go directly from phase-1 studies in healthy volunteers to phase-2a combination studies with SoC.