Appreciate your input, EW. While I agree to a level of...

Appreciate your input, EW.

While I agree to a level of speculation, I do not think it classifies as extreme. TYP have already demonstrated excellent in-human efficacy in two first-to-market opportunities, albeit in small populations. People have been consuming psilocybin recreationally for a very long time, so there are decades of safety data supporting its use clinically. There have been a number of clinical investigations involving psilocybin or the active form psilocin in a range of areas including depressive disorders (including anxiety), substance abuse disorders, eating disorders, pain, and PTSD. Systematic reviews and meta analyses have consistently shown psilocin is effective with a broad spectrum of effects both neurologically and physiologically, though larger studies of longer duration are required.

Some of the major issues with psilocybin treatment is patients start to see jesus or nothing happens, which is all related to the bioavailability (different metabolism for each person) and peak blood concentration achieved. Improving the delivery of the active compound to patients to overcome these limitations and ensure the therapeutic window is maintained should improve the benefits with minimal side effects for a wider range of people. The tipping point is the results of the P1b trial- successfully controlling peak blood concentrations within the therapeutic window and minimal safety concerns will be a milestone for TYP. TYP-8802 has already demonstrated excellent efficacy in humans to date (100% reduction in fibromyalgia pain, 80% improvement in binge eating disorder episodes) despite the common bioavailability limitations, so I think confirmation of precise blood concentrations and safety will add substantial value to TYP.

In March 2024, the FDA granted breakthrough therapy designation to Cybin's lead compound CYB003, a psilocybin analog, after it demonstrated a 75% remission rate and 22-point reduction for MADRS in patients with major depressive disorder. This is not the first BTD offered to psilocin treatments and highlights that the registrational organisations are satisfied that psychedelic substances can be effective treatment options and are actively engaged in bridging these therapies to patients.

https://www.healio.com/news/psychiatry/20240319/fda-grants-breakthrough-designation-to-psilocybin-analog-for-major-depressive-disorder