While DUPIXENT successfully manages chronic inflammatory conditions, it takes weeks to work and doesn't stop all flare-ups. This creates a market opportunity for fast-acting therapeutics that address urgent, emergency room-level episodes, a scenario DUPIXENT is not designed for.

The traditional drug-centric trial model is failing. The next evolution is trials designed to validate the *decision-making process* itself, using platforms to assign the best therapy to heterogeneous patient groups, rather than testing one drug on a narrow population.

The friction of navigating insurance and pharmacies is so high that chronic disease patients often give up, skipping tests or medications and directly worsening their health. AI can automate these tedious tasks, removing the barriers that lead to non-compliance and poor health outcomes.

Even for common conditions like pneumonia, current diagnostic methods like sputum and blood cultures fail to identify a bacterial cause in 60% of cases. This diagnostic gap leads to clinical guesswork, resulting in dangerous under-treatment. In one study, one in eight patients with a bacterial infection was sent home from the ER without antibiotics.

Despite FDA readiness for a final Phase 3 trial, Connect Biopharma chose to run more Phase 2 studies. They discovered their long-term asthma drug worked in hours, not weeks, and are now pivoting to prove its value in acute, emergency situations, which informs a stronger, more targeted Phase 3 design.

Medicine excels at following standardized algorithms for acute issues like heart attacks but struggles with complex, multifactorial illnesses that lack a clear diagnostic path. This systemic design, not just individual doctors, is why complex patients often feel lost.

A significant criticism of the pivotal KEYNOTE-564 trial is that only half the patients in the control arm received standard-of-care immunotherapy upon relapse. This lack of subsequent optimal treatment complicates the interpretation of the overall survival benefit, raising questions about its true magnitude.

Modern critical care for sepsis only treats the consequences of the disease—organ failure, low blood pressure—with supportive measures like ventilators and IV fluids. There are zero approved therapies that actually treat the underlying root cause: the out-of-control immune response that is actively damaging the patient's body.

AeroRx's core innovation is a new delivery system for existing drugs. While five dual-bronchodilators are available in handheld inhalers, none exist for nebulization. This targets older, sicker COPD patients who cannot use inhalers effectively, proving value can be created by improving *how* a drug is administered rather than discovering a new active ingredient.