Biotech Values

[DewDiligence]

IDIX – Proposed NM283 phase-3 trial design

>I really don't think it is going to come down to a non-inferiority trial.<

Let me label the arms and specify the endpoints in my hypothetical design. There are three arms as follows, each with treatment for 48 weeks:

a) NM283 + peg-interferon

b) NM283 + peg-interferon + ribavirin

c) Peg-interferon + ribavirin (Standard of Care)

The primary endpoint is SVR, defined as PCR-negativity 24 weeks after the end of treatment. The alpha (aggregate available p-value) for the trial is split into three components:

1. Superiority of arm a) vs arm c);

2. Superiority of arm b) vs arm c); and

3. Non-inferiority of arm a) vs arm b).

I hope this clarifies what I am talking about. Regards, Dew

p.s. I agree with your musings about viral resistance.