You state that you have a preference for clinical studies, and yet fail to provide a link to one that actually addresses your concerns.
For instance, the first article you quoted isn’t even a clinical study, it’s simply a summary of 1,603 articles dating back to 2007. Incidentally, the author of this article Collin M. Reiff actually follows the MAPS clinical trial closely and he published a very positive article this year titled “MDMA-assisted psychotherapy for the treatment of PTSD”. Again, this is simply a review of the clinical study, it’s not the actual clinical paper.
You also provide links to indicate that P2 and P3 trials have yet to receive approval and that the evidence so far is observational and lacking empirical evidence. This is categorically incorrect and you would be aware of this fact if you’d actually read the MAPS clinical study. Frankly, if you haven’t reviewed this literature in detail then I don’t understand the point of posting because this is the most progressed clinical trial in the sector today and the entire subject of the link that
@thevinnys provided.
The FDA granted MAPS with “breakthrough therapy designation” in August 2017 and based on the results to date it may well be the first company to receive FDA approval for MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with therapy in an outpatient setting.
This would be extremely positive for IHL, similar to the reasons we discuss the positives of GW Pharma being granted FDA approval for Epidiolex.
In the Phase 2 clinical trials MAPS treated 107 participants and the results were extremely positive. 61% no longer qualified for PTSD after three sessions of MDMA-assisted therapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.
This is neither anecdotal or lacking empirical evidence, it’s a Phase 2 clinical trial.
Building on those P2 results, MAPP1 and MAPP2 are randomized, double-blind, placebo-controlled, multi-site clinical trials to assess the safety and efficacy of MDMA-assisted therapy in up to 300 participants with severe PTSD from any cause, aged 18 and older.
The MAPS P3 trial has already received received a special protocol assessment from the FDA so we know the protocol design and clinical endpoints are acceptable to support regulatory approval by the FDA.
In other words, the research is actually showing clear and significant results. In fact the leading clinical trial in this sector specifically addresses your scepticism. I’ve got no issue with someone being sceptical, but it’s disingenuous to purport to hold this view based on scientific evidence when the very article you dismissed actually disproves your comments.
Those who understand the body of work generated by Dr Liknaitzky understand not only the potential for success but also the valuation gap that will be closed in our favour once IHL lists on the NASDAQ. Exciting times and DYOR.
