A committee member asked, "So, Dr. Schmidt, what's your overall assessment? Should this temporary pathway continue, or even expand? Should formal approval be expedited?"
Carl paused for a moment and gave a rigorous answer, "From a purely medical and patient benefit perspective, it should continue, and we should even consider appropriately expanding the range of diseases. From a regulatory and systemic risk perspective, we need to establish clearer exit mechanisms and transformation pathways. If K Therapy ultimately fails to obtain formal approval for the market, how will we handle the subsequent treatment and data ownership of these compassionate use patients? Additionally, we need to start a serious discussion about how to incorporate the cost of such breakthrough therapies into a sustainable healthcare system. This is not just a regulatory issue but also a health economic and social policy issue."
"So, your suggestion?"
