The federal agency gave the U.S. approval to London-based life sciences startup called Compass Pathways that launched in 2016 under the backing of billionaire Peter Thiel.
Regulatory approvals for the trial have already been given in the U.K., the Netherlands and Canada.
The trial is expected to be a phase IIB dose-ranging study involving 216 patients in 12 to 15 research sites across Europe and North America. The tests will begin in the U.K. later this month and sites in other countries will kick off as soon as regulatory approvals are received.
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