Can atai stock (NASDAQ: ATAI), rebound after the FDA denied approval of a new psychedelics-based treatment for PTSD?
Certainly psychedelics investors want to know. Here’s why …
On Friday, the FDA denied approval of Lykos Therapeutics’ MDMA-assisted therapy for PTSD. Following that announcement, atai stock, as well as other psychedelics stocks took a nasty hit.
If you’re unfamiliar, MDMA is a psychedelic compound. And a company called Lykos Therapeutics had successfully gone through years of clinical trials in an effort to bring this new therapy to the market. A new therapy, by the way, that could have proved to be a viable option for the hundreds of thousands of people who currently suffer from PTSD. Particularly survivors of sexual abuse, and of course, veterans.
Certainly I saw this in my own life with my Uncle Tony, who I’ve written about in the past.
Before we discuss atai stock, meet my Uncle Tony
In the early 1970s, my uncle was sent to Vietnam. When he returned home, he was a shell of his former self. I was pretty young at the time, and didn’t quite understand just how bad it was. I just knew Uncle Tony as a quiet man. He smoked a lot, and drank quite a bit, too. And it seemed like he was always sweating.
For a few years, he lived with us after his wife left him. I was never told the details, but when I got older, I found out that Uncle Tony would have violent outbursts that she just couldn’t handle anymore. He never physically harmed her, but apparently he would just wreck the house. Punch holes in the walls, break furniture, and smash mirrors. They actually had to get all of the mirrors out of the house because he kept breaking them.
In all fairness, this was the late 1970s, and not a lot of folks were talking about PTSD.
Uncle Tony went to therapy a lot. He was also always on various drugs that the VA gave him. I guess nothing really worked. And in 1986, they found Uncle Tony in a hotel room. Dead. He shot himself in the head. There was no note. No evidence of drugs or foul play. And my dad told me that the room barely looked lived in, although he had been living there for weeks.
To this day, I don’t know what Uncle Tony did or saw in Vietnam. But one of his battle buddies, and a good friend of our family, told me that he saw a lot of gruesome things that no one should ever have to witness.
If Uncle Tony were alive today, and still struggling with all those demons, I would do everything in my power to find an effective treatment for his PTSD. I definitely would’ve helped him enroll in some of these clinical trials. But as I write these words, I think to myself, why? Why should I have to jump through hoops or risk imprisonment for trying to save my Uncle’s life? A man, by the way, who served the very country that would today, deny him medication that could help him?
I reject the very notion that the government has any right to tell a sick person what treatments he or she can pursue if those treatments cause no risk to anyone else. Which is exactly what happened with this FDA decision.
Meanwhile, I’m also thinking back to how quickly the FDA approved COVID vaccines.
Those things were developed, evaluated and put on the market in less than a year. And while I’m not opposed to COVID vaccines (although I am opposed to COVID vaccine mandates), the potential risks of those vaccines seem to have been far greater than any potential risks of Lykos Therapeutics’ MDMA-assisted therapy.
Of course, I’m not on the inside of the FDA. I don’t know what it’s like to be responsible for approving new medications that could negatively affect a lot of people if the science isn’t right and well-vetted. But the way I see it, if you’re suffering from PTSD, and nothing else has worked, why shouldn’t you have access to medically-supervised MDMA-assisted treatments? It almost seems like, in this case, those responsible for making the decisions for this MDMA-assisted treatment weren’t qualified to do so.
As psychedelics investigator and journalist Zach Haigny noted in his fantastic coverage of the FDA’s handling of Lykos Therapeutics’ clinical trials …
…despite training and credentials as medical professionals – their day-to-day involvement in patient care is limited or non-existent. As a result, they are personally shielded from the on-the-ground reality of treating patients with PTSD – and the consequences for patients, families, communities, and healthcare providers.
How Long is Too Long?
The FDA is now asking Lykos to redo the study, which would likely take at least three years. How many people suffering from PTSD will not make it another three years?
It just blows my mind that when it came to COVID, it was all about saving as many lives as possible. But when it comes to PTSD, well, saving lives seems to be taking a backseat to bureaucracy and ill-advised “authorities.”
To clarify the dangers of untreated PTSD, according to the Crisis and Trauma Resource Institute, those suffering from PTSD can have …
- Up to 3 times the increased risk of chronic obstructive pulmonary disease, lung cancer, and heart disease.
- More than 4 times the increased risk of depression and up to 12 times the increased risk of suicidality.
- As much as a 20-year decrease in overall life expectancy.
Of course, complaining about the FDA’s decision won’t help these folks get the medication they need. What will help is continued research and continued investments in the psychedelics companies that are making this happen. From wealthy entrepreneurs, such as Peter Thiel (net worth: $8.1 billion), Bob Parsons (net worth: $3.6 billion), and Steve Cohen (net worth: $19.8 billion), who are ponying up millions to continue this important research, to individual retail investors investing in the best-in-breed psychedelics companies, eventually we will get these valuable medications to the people who need them.
To be sure, there are a fair amount of duds when it comes to psychedelics stocks, but there are a few that are making some real progress. These include atai, as well as …
- MindMed (NASDA: MNMD)
- Cybin (NYSE: CYBN)
- Compass Pathways (NASDAQ: CMPS)
I would also point out that following the FDA’s recent decision on Lykos Therapeutics’ MDMA-assisted therapy for PTSD, most of these psychedelics stocks tumbled to a point where they’re actually looking pretty cheap. Certainly this is the case with atai stock. So if I see an opportunity to pounce in the coming weeks, I’ll be sure to let you know.
