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The public health agency was expected to release the decision on the approval of the ecstasy-based drug the week of Aug. 12.organizations had increased lobbying efforts for the Biden administration to greenlight the treatment in the several weeks after an FDA advisory committee recommended not to approve the drug.
One chief problem, discussed in-depth during the advisory committee meeting in June, was that patients in the trial were able to correctly identify whether or not they were given MDMA or a placebo, which is a common problem when testing psychedelics. Lykos said in a press statement on Friday that company representatives intend to meet with the FDA to ask for reconsideration and to further discuss the agency’s recommendations for resubmission.
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