For nearly 3 decades, Market Access and MLR have operated like 2 departments guarding opposite sides of the same door – one trying to open it, one trained to keep it shut. That instinct made sense when the rules on talking to payers before approval were vague and nobody wanted to be the test case, but new FDA guidance just turned that gray zone into a defined, legal green light. Yet most launch teams are still playing by the old rules.

More than a third of US launches still miss their numbers, and the single biggest reason is the same one it’s been for a decade: limited market access. That’s not bad luck – it’s a process built for a regulatory environment that no longer exists. At Red Nucleus, we help manufacturers see exactly what changed, what it means for MLR, payer strategy, and technology, and how to move before the rest of the market catches up.