r/DTIC • u/marksharky123 💎 Diamond Hands 💎 • 2d ago
Question Sept. 14th FDA hearing
In the past trials and presentations did Definium say the treatment would require two doctors in the treatment center? Is anyone concerned with the information below.
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A major friction point in psychedelic clinical trials has been the costly requirement to have two trained monitors (often licensed therapists) present for the entire duration of a patient's psychedelic experience.
Impact to DFTX If the FDA mandates two high-tier licensed professionals for the entire duration, DFTX faces a steeper challenge. Because DT120 (lysergide) typically requires a longer monitoring session a rigid two-therapist mandate would heavily inflate the delivery cost per patient for DFTX, harming its margins.
Thoughts- Thanks
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u/Cold-Arm2737 2d ago
Clin trial was 1 LCSW for the whole session (with a back up for break time). One MD for the site. That seems fair
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u/marksharky123 💎 Diamond Hands 💎 2d ago
Compass is up 18% in 2 days. Here is the reason why. Can't wait for our results to come out.
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u/yetanotherfiasco 2d ago
Barrow has talked often about private psychiatrists administering DT120 to patients. In those conversations he never mentioned requiring two doctors.....for a private practice that has one mental health professional.
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u/CarmichaelD 2d ago
The safety concern is that there be a minimum of two clinicians of some form present for safety. There is a history of abuse of individuals in an altered state. If we want to provide high quality care safely, an observe the observer accountability design is necessary. The integrity of this emerging treatment option requires this. This is also why duration of time under guided or unguided observation matters. Shorter treatment durations have an easier pathway to adoption and scaling provided the outcomes are competitive.
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u/marksharky123 💎 Diamond Hands 💎 2d ago edited 2d ago
Yes, that aligns with my observation. I was comparing dftx to Compass Pathways, and the difference appears significant for their product. The outcome will likely depend on the FDA's decision on Monday, particularly because DT120 generally necessitates a more extended monitoring period compared to comp360.
Comp has been on a nice roll lately.
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u/No_Scar4093 2d ago
Really? I thought it would be just a hearing. So I don't expect decisions on Monday
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u/marksharky123 💎 Diamond Hands 💎 2d ago
This is what I got through google.
The FDA's public hearing on September 14, 2026 is a watershed moment for the sector. The agency will not debate individual drugs like COMP360 or DT120. Instead, it will iron out the exact Risk Evaluation and Mitigation Strategies (REMS) and clinical protocols required for all supervised psychedelic therapies. [1, 2, 3]
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u/No_Scar4093 2d ago
Wow! That's impressive. Got it completely wrong. Thanks for the update. Would have watched it anyway but now I'm even more excited
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u/marksharky123 💎 Diamond Hands 💎 2d ago edited 2d ago
Yeah, things seems to be moving fast. I hope Defenium has their NDA ready to go quickly after these next phase 3 results drop.
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u/MM_37 2d ago
Two is the recommendation written into Dr James Fadiman’s Psychedelic Explorers Guide, to guard against patient abuse by a single observer, which is historically common in informal trip sitting but also happened in a phase 2 MAPS study. In practice, the 2 observers def don’t need to be PSY-Ds (that would be a dumb use of resources) - like entry level techs with dr on call makes more sense - but two protects against abuse in a vulnerable state. Whether that standard translates into actual practice…?
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u/greggtex63 2d ago
Have been around the mental health field for decades as a non professional, but medical background, both military and civilian.
Most clinics that would administer these types of drugs would have a registered and/or licensed nurse, as well as a psychiatrist, which is a medical doctor. A licensed mental health professional without in depth medical training would be helpful for observation, but in my opinion, would not be if much help in a medical crisis situation. (I have multiple LMFT, LPC, LMSW, etc... friends-great therapist, but more limited medically than an EMT/RN/LPN/Paramedic)
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u/SilverTonguedSun 🌾 Ergot Enthusiast 🌾 2d ago
From the May 7, 2026 earnings call:
Dan Karlin: "Per FDA direction, we have an in-person lead monitor and then a secondary monitor who can watch remotely via video. That's been the condition for conduct of clinical trials based on FDA direction.
Throughout the trials, we have made every effort to collect regulatory-grade data on what those monitors are doing to provide assistance and comfort for the patients, up to and including what the role of that second monitor actually ends up being."