A quick note before we dive into this week’s news …

Gilgamesh Pharmaceuticals, one of the most successful holdings in the JLS Fund, was recently included in Fierce Biotech’s “2024 Fierce 15” report.  This is a very big deal as this gets the company in front of nearly 100,000 biotech professionals and high-net worth investors. 

If you’re unfamiliar, FierceBiotech is a free daily email newsletter and web resource providing the latest biotech news, articles, and resources related to clinical trials, drug discovery, FDA approval and regulation, biotech company deals, and more. It serves as the biotech industry's daily monitor for their entire biotech industry. 

You can read the entire report here: https://www.fiercebiotech.com/special-reports/introducing-fierce-biotechs-2024-fierce-15

The FDA withdrew a request for White House permission to conduct a study about the risks of using psychedelics amid a “rapid resurgence” of public interest in the substances. Advocates celebrated the news after criticizing the initial request as another example of FDA “bias” against harm reduction options.

In an initial notice published in the Federal Register earlier this month, FDA said it planned to open a 60-day public comment period for interested parties to weigh in on the proposed survey, which needed to be cleared by the White House Office of Management and Budget first. But in a reversal, it withdrew the notice on Monday.  Here’s more: https://www.marijuanamoment.net/fda-withdraws-request-for-white-house-permission-to-study-kratom-and-psychedelics-risks-amid-criticism/

atai Life Sciences announced positive preliminary results from its Phase 1b trial of VLS-01, its proprietary oral transmucosal film formulation of DMT that is applied to the buccal surface.

The Phase 1b trial demonstrated a favorable safety profile and was well tolerated, with all adverse events classified as either mild or moderate, and most resolving on the day of dosing.

VLS-01 is being developed for patients living with treatment-resistant depression.  Check it out: https://www.globenewswire.com/news-release/2024/08/13/2929035/0/en/atai-Life-Sciences-Announces-Positive-Preliminary-Results-from-Phase-1b-Trial-of-VLS-01-Buccal-Film-DMT.html

The Olympia, WA City Council unanimously approved a resolution to effectively decriminalize plant-based hallucinogens, such as psilocybin mushrooms. 

The resolution focuses on mental health as a justification to decriminalize the psychedelics while pointing out the FDA held sanctioned trials that show "positive results that demonstrate the safety and efficacy of psilocybin assisted therapy."  
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Under the terms of the resolution, plant-based hallucinogens would be considered a low priority of police, with no city funds or resources being used for investigation, prosecution, or arrest of people possessing or using the psychedelics. Here’s more: https://www.king5.com/article/news/local/olympia/olympia-decriminalizing-psychedelic-plants-fungi/281-3a5dbe36-73e9-41ae-be39-0413a602e65c

Did you know that a new brain-computer interface has proved successful in translating signals into speech?

This new brain-computer interface (BCI) technology is currently being developed to restore communication for people who can’t speak due to paralysis or neurological conditions, like ALS. It can interpret brain signals when the user tries to speak and turns them into text that is ‘spoken’ aloud by the computer.

Neuroscientist Sergey Stavisky commented on this BCI technology, saying …

We’re really detecting their attempt to move their muscles and talk. We are recording from the part of the brain that’s trying to send these commands to the muscles. And we are basically listening into that, and we’re translating those patterns of brain activity into a phoneme — like a syllable or the unit of speech — and then the words they’re trying to say.

You can read more about this particularly BCI technology here: https://www.technologynetworks.com/neuroscience/news/braincomputer-interface-translates-signals-into-speech-with-97-accuracy-389800