Roundtable Discussion: Using Real-World Dopamine Add-On Templates to Illuminate Regulatory Paths for Combination Labels & Unlock More Effective Multi- Mechanism Therapies
- Have the modest effect sizes of stand‑alone antibodies accelerated the field’s appetite for multi‑mechanism therapeutic strategies?
- What specific regulatory hurdles must be overcome to secure combination labelling and achieve smoother NDA reviews
- Add-on dopamine replacement examples from early PD studies illustrate feasibility – how can these real-world templates be used as ready-made protocol blueprints?