Comment from BioinvestGPT ApS

Summary: BioinvestGPT ApS, a biotechnology company, proposes that the FDA include "first-in-human-blinded mechanistic prediction" as a specific tool class within the pilot program. They argue that their AI tool, BVCT, can provide high-accuracy, patient-data-free predictions to inform go/no-go decisions at the Phase 1 to Phase 2 transition.