In this Issue
- Lykos CEO Provides AdComm Feedback to FDA Commissioner
- Cybin Plans to Fight Functional Unblinding with ‘Firewall’
- Doblin Charts a Future for MAPS • DEA Plots Ketamine Crackdown
- Colorado Closes First Round of Rulemaking for State Psychedelics Program.
- Other Stories, including: MindMed’s Phase 3 program; upcoming FDA-affiliated event on PTSD treatments.
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Lykos CEO Provides AdComm Feedback to FDA Commissioner
Days after the FDA communicated to Lykos Therapeutics that it would not approve MDMA-assisted therapy for PTSD at this time, the company’s CEO, Amy Emerson, penned a letter to the agency’s Commissioner, Robert Califf.
In the letter (PDF), Emerson provides the company’s feedback on the Advisory Committee (AdComm) process generally, as well as Lykos’ own ill-fated meeting (see Analysis: FDA Advisory Committee Snubs MDMA-Assisted Therapy for PTSD in Overwhelming “No” Vote; Live Coverage: FDA Advisory Committee Reviews MDMA-Assisted Therapy for PTSD). Her comments range from the composition of AdComms through to the role of the chair and voting.
Some of the Lykos CEO’s suggestions echo those made by other pharmaceutical companies, such as dropping ‘no-conflict’ requirements that restrict voting participants from having substantive conflicts of interest and scrapping the voting element of the agenda…
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