Biotech Values

[genisi]

Q: Why would GILD exclude GT2/GT3 and test GT1,4,5,6 in the NEUTRINO study?

Remember data from the ELECTRON phase IIb trial showed that sofo monotherapy isn't enough but 12 weeks of sofo+riba cured all GT2/3 patients and adding interferon made no difference in SVR. So I believe GILD designed phase III program for GT2/3 while expecting this was the right combo just as they knew it takes another agent for GT1. It was later when data from POSITRON phase III in GT2/3 showed a low SVR of 61% in GT3 patients. Perhaps the question is why not start another trial (adding an arm is too late now) and my guess is they wait for the last phase III results and will go to the FDA and in case the FDA insists on better SVR for GT3 they will start a new trial with another agent.