CONFIDENCE !!!! The company is so CONFIDENT in their product, that they are willing to allow the FDA to basically plan their trial to meet their strict requirements. The company is so confident in fact, that they are willing to allow the FDA to scrutinize the trial and make sure it stays exactly on track according to both parties AGREEMENT. The company is so CONFIDENT, that the goals and outcome will meet or exceed the FDA's expectations . If those expectations are met, approval is guaranteed at the end of the trial. They also have an option of evaluation halfway through the trial for an early NDA which also would mean guaranteed approval.

When THLD announces that they have met their primary endpoint for OS, it means they have met the FDA's expectations. Numbers at that point would not matter.

However, a trial designed without the cooperation of the FDA, would mean a " Self Proclaimed " success of meeting it's primary endpoint . That's a gamble and could lead to a CRL from the FDA.

Celgene does not have a SPA with their phase 3 pancreatic trial. THLD has a SPA in place.