"As we prepare to address the FDA decision, we need to focus on delivering the FDA the robust clinical data necessary to support the approval of this potential new treatment," Amy Emerson, the CEO of Lykos, said in the statement.
"This is the first time the agency has considered a psychedelic for medical use," highlighting the significant nature of the FDA's decision and its implications for future psychedelic therapies.
Lykos believes that MDMA, commonly known as ecstasy or molly, can help people with post-traumatic stress disorder, including veterans and survivors of sexual violence.
Had the FDA approved MDMA, Lykos Therapeutics had the potential to become a multibillion-dollar company, indicating the high stakes involved in psychiatric drug approvals.
[
Collection
]
[
|
...
]