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Mydecine CEO Josh Bartch on FDA News and Smoking Cessation Treatments

We last heard directly from Mydecine Innovations Group (NEO: MYCO)(OTCMKTS: MYCOF) at the end of January. Mydecine CEO Josh Bartch is back to sit down at the table with Shadd and The Dales Report to fill us in on the company’s latest news.

Here’s some highlights from the interview.

Post COVID, Poor Mental Health Pushing Changes

With the pandemic not so far behind us, mental health is worse than ever. There’s an importance in pushing for innovation and new, different mental health treatments, says Bartch. He believes that psychedelics offer that.

“It’s absolutely true,” says Bartch, “that there is a massive problem in, one, the way we’re treating mental health, the attention that we’re giving it, the available treatments; but two, there’s a problem with some of the first-generation drugs that are being developed in psychedelics.”

The biggest problem? The cost associated with the drugs, once they commercialize. And a large portion of the cost is needing to have practitioners minding a single patient for up to eight hours for a single treatment.

Mydecine Molecule MYCO-001 Cleared By FDA For Smoking Cessation

Reducing the duration of the psychedelic experience without losing the benefits of the psychedelic is the holy grail for many pharmaceutical companies. Eventually, Mydecine and Bartch hope that MYCO-004 will fit that bill. But the first step is experimenting with the pure, OG molecule itself.

In big news for Mydecine, MYCO-001 was cleared by the FDA just last week for use in smoking cessation treatments. This gives the planned Q2 study with John Hopkins, in conjunction with NYU and the University of Alabama Birmingham, a chance to go ahead. Hopkins will be using the MYCO-001 molecule and the niacin placebo both provided by Mydecine. Mydecine will be getting back all the safety and efficacy data, which Bartch says will help support their own phase IIb trial and eventual submission.

Smoking Addiction ‘A Unique Indication,’ Says Bartch, Which Makes Mydecine Study Significant

Unlike cocaine, opiod or alcohol addictions, there are no significant comorbidities associated with smoking. Patients with other addictions have lives ‘in shambles,’ says Bartch. But the smoking population? “These people are living normal lives,” he says. And it’s bizarre, the way we treat a substance that’s by far the deadliest of all the substances abused combined.

The smoking cessation market is worth a projected $64bn by 2026. The only real smoking cessation treatment drug had a success rate in single digits, and was recently recalled for containing a carcinogen. While psilocybin will always need to be done in the right set and setting by trained professionals, he argues, he believes that the efficacy is at least as good as Chantrix, and far safer.

Be sure to tune in for the full interview, to hear everything Bartch has to say about Mydecine’s upcoming strategy for the next 12 months, and how they are faring despite the upheaval in the market for psychedelic companies. This and more, right here on The Dales Report.

The Dales Report Inc. disclosure policy applies to this post    
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