Biotech Values

[oc631]

GILD—The “new data” on 16w of treatment with Sofosbuvir + ribavirin in treatment-naïve GT3 was not real data from a clinical trial, but rather a mathematical extrapolation by the FDA of GILD’s phase-2 data in treatment-experienced GT3 patients

How many companies are granted the favor of the FDA mathematically extrapolating data on extended dosing (outside of the original design)? Why didn't the FDA extrapolate the results for 12w of Sofo/PegRiba in GT3 patients? Does anyone else think 85-93% SVR rates for 24w of Sofo/Riba dosing in GT3 is wildly optimistic?


Did anyone listen or follow the ADCOMM meeting? Did the committee ask why GILD chose not to advance the Sofo/PegRiba option in GT3 treatment-experienced patients after seeing 68% SVR rates (12w) in ELECTRON? Why GT2/GT3 treatment-naive patients were written out of the NEUTRINO study? Was it prudent to believe these patients would never need an interferon-based option? That Sofo/Riba would show 100% SVR rates in the real world setting?