We appreciate the profound support and efforts of those who share a mutual commitment to improving outcomes for patients living with #PTSD. Currently, our priority is to work with the #FDA to address any outstanding questions raised during the recent FDA Advisory Committee meeting and provide information to help inform the decision-making process. Amy Emerson, CEO of Lykos Therapeutics, shares more on our next steps in an open letter here: https://lnkd.in/eeM_KjHx
Jim Kiely
1mo
it’s my firm belief after reading last year’s FDA guidance on conducting psychedelic clinical trials, attending public agency meetings on the subject and - believe it or not - reviewing last week’s advisory committee meeting, that the FDA considers MDMA, psilocybin and other drugs potentially beneficial to people in ways that can be scientifically deduced from and confirmed by data. Lycos is in the vanguard and therefore left to resolve clinical and nonclinical issues particular to MDMA and similarly classified drugs. I believe you’ll succeed in time and create standards for others to follow. Here’s to that day.
Sara M.
1mo
I believe in advancing clinical care and providing options and evolution in treatment for PTSD and other conditions psychedelics might be used to treat. However, I am concerned about the attachment of an unclear therapeutic design to this medication and for the incredibly disturbing experiences some of MAPs/Lykos patients experienced. I don’t think this letter adequately addresses those patient experiences or concerns about therapeutic treatments employed in these trials. I also believe psychedelics will make their way into clinical care, but I am not certain if this company or these trials should be the ones to usher it in. I’ve been a believer in MAPs for a long time, but this panel’s review and Lykos’s response to the named concerns is disappointing.
Moving forward! and fingers crossed
Beth Ehrgott
1mo
❤️🩷❤️🩷
Aprozen Pharma
1mo
Best of Luck for further steps
Rony Morrison
1mo
Best of luck!
Michelle Benton
1mo
Keep growing!
Founder/CEO @ TARA Mind | Founder/Chairman @ VETS | MBA | Veteran Navy SEAL
1moNot worried, this will happen. MDMA-AT will change the future of therapy, especially for PTS and couples therapy…✌🏽