Biotech Values

[genisi]

... the agency concluded that "it is not possible to make definitive conclusions about the treatment effect of tofacitinib on structural damage progression.

Think the FDA knows that radiographic progression is a difficult endpoint (although I agree, very important for long term efficacy evaluation in RA, but I will add that the other endpoints are no less important). While data were not definitive in the radiographic trial, the higher dose did show a stat-sig effect (although due to small subgroup), and the trend was positive in the lower dose as well, plus there was very little structural progression in the placebo group. Given the above, I think the FDA sees the overall efficacy positively and will approve in patients who failed anti-TNF therapy as they also have an unmet need.