Biotech Values

[oc631]

Thus, even with 16w of treatment, genotype-2 patients did 3,200 basis points better than genotype-3 patients.

This Phase 2 study of GT3 patients using an interferon-based combo is over two years old and, according to the CT website, it's still recruiting as of 12/2012.



http://www.clinicaltrials.gov/ct2/show/NCT01260350?term=sofosbuvir&rank=6




GILD denied GT2/GT3 treatment-naive and treatment-experienced patients a new interferon-based option by not advancing them into NEUTRINO.

The kind way of looking at this is GILD thought Sofo/Riba would show 100% SVR rates in all GT2/GT3 patients within the U.S. once the combo hit the market so what's the point?

Now we have sub-optimal oral results in GT3 compared to what's being seen in other genotypes. Should the FDA approve an oral combo that works in slightly more than half of GT3 patients? Would the FDA's decision be different if GT3 patients were showing 90%+ SVR rates in NEUTRINO using sofosbuvir/interferon-based therapy?