The CRL (Complete Response Letter) was handed down by the FDA today, and for many it feels like a defeat. We are going to counter that position. Not because we are a nonprofit dedicated to this movement, or because we simply have time invested in a cause and can’t let go, but what the CRL shows us is the promise of CLARITY.
The CRL affirms the FDA’s belief in MDMA-assisted therapy as a treatment for PTSD. This in itself is an incredible accomplishment that was made possible by the investment of time, energy, and heart by scientists, advocates, and participants. This work will continue, but we can all take a moment to celebrate that today.
While the CRL indicates that we have more work to do in refining research-backed guidance on the safety and efficacy of psychedelics use, the extensive feedback typically offered in a CRL is a CLEAR ROADMAP for approval that we could not have imagined 40 years ago, when MDMA was first banned. This marks profound progress, and that is worth celebrating.
We now have EVERYONE at the table. While we have spent years debating, wondering, hoping, that the mission of Lykos and the layout of their study would work, we now have EVERY player at the table. It’s a solid discussion now. It’s the real negotiation—-‘Tell us what you need to understand, and how you need it presented so that it feels reliable.’ We now have all sides of the die to take into account. We are no longer rolling the dice, we can now research and disclose every answer to every question on any side we land on. Now…..EVERYONE is in the game.
We applaud the efforts of Lykos to be willing to step up and create a study worthy of a CRL.?It takes courage to be the one to step in and test the waters. It has been a bold, passionate, and sincere effort. If their study had no legs, there would be nothing to build on. Make no mistake, we are BUILDING.
To all those seeking this treatment and feeling discouraged, dismissed, and disheartened, we will continue the work needed to bring this treatment to you. The last player has entered the game. Now we get to build the strategy together. That in itself is monumental. That in itself is hopeful.
Hang on.
We see you.
We are not done.?
We will get there.?
And until we do….we are still here to help everyone in their healing process in all ways available.
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