MDMA-Assisted Therapy: With One Successful Phase 3 Study, Is FDA Approval on the Horizon?
Time: 3:00 pm
day: Day One
• Brief overview of where we are with current research and introducing the basic model of treatment, how it works and defining the path forward
• How do we navigate movement from public enthusiasm and newly positive clinical data to a delivery model that is broadly helpful?
• Evaluating our Phase 3 results
• Victories with the FDA post approval regulation, how can we make these therapies more palatable to the regulatory authorities?
• Risk evaluation mitigation strategies for post approval regulation
• Financial projection, what does the sales market look like?
• What is the income potential from data exclusivity?
• Further research and collaborations and the future vision of psychedelic assisted treatment centers worldwide