Insights

Read our independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture.

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The latest

‘No Prejudice, No Hype’: Florence Butlen-Ducuing on Europe’s Psychedelic Renaissance

From a long stint at the European Medicines Agency’s (EMA) Office of Therapies for Neurological and Psychiatric Disorders to her present-day practice as a clinical psychiatrist at leading cancer research hospital Gustave Roussy, Dr. Florence Butlen-Ducuing has had a front-row seat to the evolution of psychedelic research and drug development in Europe.

Unpacking FDA’s MDMA Rejection Letter and the Road Ahead for Lykos

Last Thursday, FDA published the complete response letter (CRL) it sent to Lykos Therapeutics last year, when it rejected its MDMA for PTSD new drug application. Here, we take a closer look at the three dealbreaking issues, speak with insiders and observers about its contents, and discuss what it might mean for Lykos’ road to resubmission.

The Library

Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

It’s exclusively available to our Pα+ subscribers, with new content added regularly.

Pα+ Library: Bifurcated Scheduling

Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.

Pα+ Library: Psychedelic REMS

Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

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