Biotech Values

[gofishmarko]

re : IDIX – Proposed NM283 phase-3 trial design

I can see the benefits to such a trial design for the purposes of labelling , marketing the drug , etc. , assuming the trial works out as planned. If there is any doubt as to outcomes , however , a single-arm trial where all of the alpha is spent on their best shot makes more sense to me , although I can see how that might not be true if they are able to efficiently apportion the alpha between the 3 arms in your design. If IDIX' first P3 in naives is a failure , the second attempt could well be against a new SOC which has SVR rates of 80-90% , if VRTX gets lucky , so I think IDIX needs to get it right the first time. Their track record in HBV makes me think that the HCV P3s will be well thought out , though.

I still think they will need to see some benefit with the addition of ribavirin to avoid large , slow-enrolling trials , but again , looking at the recent HBV P3 , large trials don't seem to bother them. I'm assuming that if they do get a substantial boost with riba addition that they would , in fact , go with a single tx. arm P3 trial.