Replies to post #160680 on Biotech Values

[DewDiligence]

GILD—The news from Japan creates many questions. Did GILD approach the Japanese regulators with a GT2/GT3 design? Did the Japanese regulators insightfully suggest GILD could do better in GT3? Or did GILD take it upon themselves to file solely in GT2?

The GT2-only design probably arose from a combination of the low prevalence of GT3 (relative to GT2) in Japan and the Japanese regulators having done their homework regarding the poor efficacy of the regimen in GT3.

…why didn't they [GILD] do this in the U.S.?

They may end up wishing they had, especially if the FDA convenes an advisory panel.

[oc631]

They are now testing Sofo/PegRiba for 24-weeks, a study that conveniently won't mature until after oral review.

Can anyone point to data suggesting 12-weeks of Sofo/PegRiba isn't long enough to produce exceptional SVR rates in GT3?