A Glimmer of Hope for the FDA and MDMA?
It was a gut punch to the psychedelic industry when the FDA’s advisory committee voted 9-2 and 10-1 against approval of the use of MDMA to treat PTSD.
There has been a lot of finger pointing and speculation as to how this will affect the future of FDA-approved MDMA therapy. In truth, no one really know what the FDA will say in their final decision (which is expected by mid-August) to approve or deny MDMA treatment for PTSD.
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But those in the industry are scouring anything we can find to give a glimmer of hope that the FDA may not follow the advisory committee’s rejection of the Lykos clinical trial findings. The issues with Lykos’ clinical trial have been disturbing and well documented. Below are three tweets that imply that the FDA may have a deeper insight into the Lykos trial data (especially around blinding). And there may be some things going on behind the scenes that the advisory committee may not have been aware of.
First up is this tweet by Jules Evans, author of author and editor of ecstaticintegration.org.
And there’s this post from Matt Baggott, who is the CEO of Tactogen.
And last but not least, Rick Doblin said there’s a “greater than 50/50 chance” the FDA approves MDMA in August based on some similar insights above.
Is this a lot to hang your hat on? Maybe! Or maybe not. But if there’s a chance that the FDA is looking at this problem through a different lens than the advisory committee, then there may be a chance they still approve it in August. With a high likelihood of increased restrictions or alongside a 4th clinical trial. Which would still give those who need this treatment the most a chance at getting access to it.
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