On March 7, 2024, an LSD formula (MM120) was granted Breakthrough Therapy Status by the FDA. According to the FDA, the “Breakthrough Therapy Status” designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. This also means the LSD formula has received the “Fast Track Designation”, which is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet need.
Learn more about Breakthrough Therapy Status here: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy