Peter Keks รีทวีตแล้ว
Today’s Presidential Executive Order on #psychedelics marks a major milestone in the history of these valuable substances.
It corrects a fundamental mistake made in 1970, when President Nixon established the Controlled Substances Act (CSA) and classified psychedelics as Schedule I substances - a designation that had no basis. For largely political reasons, these highly promising compounds were pushed out of the medical realm and into illegality.
Now, they are coming back - with force.
The executive order is directing the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Department of Justice and other federal agencies to reduce the red tape and restrictions that have long stymied researchers and biotech companies in the field.
As a result, I expect drug approval processes to accelerate and become less costly.
I am very proud that @ataibeckley is at the forefront of this field, with one of the broadest pipelines in psychedelics, including clinical programs focused on DMT, 5-MeO-DMT, R-MDMA and – as previously disclosed - ibogaine and additional novel, discovery compounds in various stages of preclinical development.
Since I founded AtaiBeckley in 2017, and seed-funded @COMPASSPathway that same year, these two companies have raised more than $1.5 billion to advance clinical research and development of psychedelic therapies.
As access to capital was limited early on - since most investors dismissed the idea as crazy - I invested over $100 million of my own capital and have never sold a single $ATAI share (nor do I intend to).
The public sentiment around psychedelics as FDA-regulated drugs has gone from “this is a crazy idea that will ruin your career” to being on the verge of what the market anticipates will be the first regulatory approval of a psychedelic with COMP360… all in less than a decade. What a journey.
But we are still only at the beginning.
I strongly believe the world will benefit from the full spectrum of psychedelic compounds that demonstrate medical and commercial value. I also believe that delivery mechanisms and treatment duration are critical, as these therapies must fit within the commercial realities and infrastructure of the U.S. and global healthcare systems.
That conviction is exactly why AtaiBeckley has built such a broad and diversified pipeline with a focus on short-acting psychedelics:
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Once approved, I expect physicians will determine which treatments are best suited to specific patient profiles. Over time, better data and real-world evidence will significantly improve this matching - delivering the right FDA-approved treatment to the right patient.
This level of presidential attention also reinforces another long-held belief of mine: the support – and potential use - for psychedelic therapies is far larger and broader than most people have historically assumed.
Take once more AtaiBeckley as an example. Most analysts currently model compounds like BPL-003 and VLS-01 primarily within treatment-resistant depression (TRD) - patients who have already failed at least two antidepressant treatments. But my own personal view (and ultimate vision) would be to progress to these treatments sooner, especially when existing treatments often have limited efficacy and significant side effects.
Given the favorable safety profiles and promising efficacy of psychedelics we are seeing in the clinical trials run to date, and based on my own extensive discussions with therapists who have worked with these compounds, I personally believe psychedelic therapies have the potential to become first-line treatments - and, over time, even potentially play a role in prevention.
Thank you, @realDonaldTrump, for today’s important signal of support, and @joerogan for driving it!
Most importantly, thank you to everyone working behind the scenes to make this possible today - and to the fellow drug developers advancing these therapies.
This has been, and will continue to be, a truly collaborative effort. You can all be proud of the meaningful difference you are about to make for the millions of patients in need.
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