Intro: When “positive” data isn’t enough for price Teams celebrate a Phase 3 readout: primary endpoint met, safety clean, filing on track. But the mood changes once pricing and HTA teams start modelling. The comparator used in the pivotal trial doesn’t align with real-world standard of care in major markets. Suddenly the asset struggles to show incremental value. HTAs downgrade the evidence. Payers push for deep discounts. A program that looked “de-risked” hits a commercial wall. This is more common than people admit—especially in global programs trying to reconcile FDA expectations with EU access realities. Why this happens in real…