They hit the statistical significance BUT their SPA called for a 20% point increase in CFA for the below 40 subgroup which they didn't meet. The US data would fit but overall it doesn't. So at best the data is mixed and for a company going through cash at a fast pace and losing 2 partnerships they need some sort of cash infusion. Bottom line they needed clean good results even if it proves out something happened in the x-US sites and they eventually get approval, they can't afford a negative market reaction at this time.