Three MDMA therapy papers retracted over ethics violations
https://www.statnews.com/2024/08/11/mdma-ptsd-lykos-maps-retractions/

https://www.npr.org/sections/shots-health-news/2024/08/09/nx-s1-5068634/mdma-therapy-fda-decision-ptsd-psychedelic-treatment

"On Friday, drugmaker Lykos Therapeutics received word from the Food and Drug Administration that the agency has decided not to approve MDMA-assisted therapy for PTSD at this time. Instead, the agency asked the drugmaker to further study the safety and efficacy of the treatment."

Good market to play following recent news.
Do you think this is overvalued after the FDA denied Lykos's NDA? Or do you think that approval in the next 5.5 years is still likely?

It's "before 2030" so in the next 5.5 years, not 6.5.

The appeal might take a few months. Then 1y to raise funds and prepare the next trial. Then 2y to run the trial. 1y to analyze the results and apply again to the FDA. And 1y for the FDA to make their decision. That's about 5.5 years. So theoretically doable if they execute perfectly. It seems unlikely to me.

However other manufacturers might overtake them in the meantime?

My bad! I gotta stop logging on here late at night lol

@mods It won't let me delete the first June 4th annotation.

can you elaborate?

looks like it is gone now? I pressed delete twice, waited for the 'please wait' animation for a while, reloaded the page a few times, and it was still there. Looks like either someone took care of it or it finally deleted. Thank you for responding either way <3

https://www.nature.com/articles/d41586-023-02886-x

The psychedelic drug MDMA, also known as ecstasy or molly, has passed another key hurdle on its way to regulatory approval as a treatment for mental illness. A second large clinical trial has found that the drug — in combination with psychotherapy — is effective at treating post-traumatic stress disorder (PTSD). The results allow the trial’s sponsor to now seek approval from the US Food and Drug Administration (FDA) for MDMA’s use as a PTSD treatment for the general public, which might come as soon as next year.

Likely, this will happen way before 2030. I made a market for mid 2024:

"MAPS PBC expects to submit the new drug application to the FDA in the third quarter of 2023" https://mapspublicbenefit.com/press-releases/maps-pbc-announces-positive-results-from-confirmatory-phase-3-mapp2-trial/

In July 2022, a letter from the U.S. Department of Health and Human Services was made public describing the Food and Drug Administration’s “anticipated approval…within approximately 24 months” of MDMA as a legally prescribed adjuct to psychotherapy for PTSD.