Biotech Values

[oc631]

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?

It would be justifiable for companies such as VRTX, IDIX, and JNJ, that intend to compete in the oral GT3 space, to file a Citizen's Petition to the FDA claiming GILD may have withheld data by not advancing patients into the NEUTRINO study. If the GT2/GT3 Phase-2 Sofosbuvir/PegRiba data isn't released by the time the Sofo/Riba NDA goes before the advisory committee the interferon-based study will be over 3 years old and support the claim GILD is dragging their feet. Pointing out that the barrier to off-label reimbursement for GT3 patients using Sofo/PegRiba would be exceedingly low, offering GT3 patients a better chance at achieving a SVR, is another valid claim.