Lykos Therapeutics, whose lead asset, midomafetamine capsules (MDMA), failed to win the FDA nod in August, said that the regulator has indicated a path forward for the Ecstasy-based drug, which, if approved, could have been the first psychedelic-assisted therapy.
Midomafetamine, based on the mind-altering drug MDMA, commonly known as Ecstasy or Molly, was rejected by the FDA in August for the treatment of post-traumatic stress disorder ("PTSD") in adults.
Announcing the FDA’s complete response letter indicating the rejection, the privately held biotech said at the time that it would seek a meeting with the FDA to obtain the regulatory feedback regarding a potential resubmission of its marketing request.
In a press release late Friday, Lykos said its new leadership, including interim CEO Michael Mullette and medical chief David Hough, conducted a meeting with the FDA last week.
“The meeting resulted in a path forward, including an additional Phase 3 trial and a potential independent third-party review of prior Phase 3 clinical data,” the San Jose, California-based drug developer added.
The update is expected to renew interest in psychedelic drug developers, which traded sharply higher last week amid a private placement worth $35M for Bright Minds Biosciences (NASDAQ:DRUG)
Sean Parker OP : In addition to Bright Minds Bio (NASDAQ:DRUG), other notable gainers included 180 Life Sciences ( $180 Life Sciences (ATNF.US)$ ), Clearmind Medicine ( $Clearmind Medicine (CMND.US)$ ), Mind Medicine ( $Mind Medicine (MNMD.US)$ ), GH Research ( $GH Research (GHRS.US)$ ), Cybin ( $Cybin (CYBN.US)$ ), Atai Life Sciences ( $ATAI Life Sciences (ATAI.US)$ ), Revive Therapeutics (OTCQB:RVVTF), Enveric Bio ( $Enveric Biosciences (ENVB.US)$ ), and COMPASS Pathways ( $COMPASS Pathways (CMPS.US)$ ).
Arrayfunction : Yikes. The comment about independent review is unsettling. That's not something that should be happening. The entire trial design, including how the results will be analyzed and reported would have had to been approved before the start unless they intentionally YOLO'd
Sean Parker OP Arrayfunction : that's how drug was in the beginning. I had quite a few shares waiting on them to approve what they had. i waited for a couple months and gave up on the idea. I sold 2 months ago and missed out on all the recent gains. I'm not saying to buy anything at all, I haven't even bought into any of these yet. I just put them all on there own watch list and hope for good news. also, I just like posting things for people like you to give your opinion.
Arrayfunction Sean Parker OP : Sorry for the confusion! I was actually doing exactly what you had intended. I may not have been clear
It was just a comment as I don't know if I have ever seen that before. I didn't take your post as any sort of advice so there was nothing I could be criticizing. My bad!
Sean Parker OP Arrayfunction : no worries at all. I didn't take it that way. I appreciate everyone's input.
Arrayfunction Sean Parker OP : I appreciate your time and effort for keeping folks informed. I try every now and then to teach newer users the dangers of thinking biotech behaves like any other industry, with their silly ideas like logic and wanting to be in business 15 years from now. I hadn't realized how much social engineering they use in their PR until recently. (e.g. allowing people to get confused over a patent for a technology that may or may ever get used vs a patent for a drug). I used to just watch for clinical trials results for my own conditions.
Sean Parker OP Arrayfunction : that's actually a very keen observation that I honestly didn't notice. The tech patient vs the actual product patient. that's why I post things, you helped me and probably didn't even notice lol. if i didn't work 12 hr nights I would be way more active. it's hard to be a day trader and work 5pm-5am. most of my news i post, I don't even get to capitalize on because I'm asleep lol. I love this app because at least half of what I've learned is from other nice people. I'm just trying to return the favor the best I can.
Arrayfunction Sean Parker OP : I have the same feeling! That's why I think it's so cool when people come together with their own teeny tiny wedge of knowledge and make a more complete picture for everyone.
Because that's the foundation that lets me spot things like the patent wordplay. I didn't *know* companies would do that until I saw it on the news tab and got suspicious lol.
I tried to make a few couple guide posts on my account covering what I know about biotechs that cause them to make no sense haha. Also some stuff about abbreviations, timelines, etc.
Sadly Moomoo is terminating my account at the end of the month due to "highly critical and defamatory comments you posted on third-party platforms regarding Moomoo and our services!" So you are welcome to archive them or repost or whatever it's called here if you think they could still help others down the road!
Sean Parker OP Arrayfunction : so you're being kicked off for saying bad things about moomoo? that sounds crazy. I personally like moomoo more than any other service. I can't believe they can kick you off just like that. I'll have to look into your page. I don't really look around much on other people's pages, but yours sounds like it'll be worth a look. you give the most thought-out comments.
Arrayfunction : I don't want to get into too much of it publicly since the next sentence of the letter was "While we reserve the right to pursue any legal remedies available to us, we
wish to move forward amicably" and it's FINRA's inquiry to handle now.
What I *can* say is negative reviews are legally protected from punishment under the Consumer Review Fairness Act. Much like how a company can't retaliate for a whistle blower complaint, they can't retaliate for an honest review despite how bad.
I can also say these are the 3 criteria someone would need to demonstrate before it can be deemed defamation and the CRFA protections removed. The burden of evidence is on the company - they have to prove it
Falsity: The statement is factually incorrect (CRFA, 15 U.S.C. § 45b(b)(1));
Actual Malice: An intent to cause harm, not reflective of my genuine experience (First Amendment, case law);
CRFA Protections: Statements based on personal experience are protected when shared without malice (CRFA, 15 U.S.C. § 45b(b)(2)).
I can also say Per the CRFA, an agreement that violates public policy cannot be used to penalize customers for sharing lawful reviews (CRFA, 15 U.S.C. § 45b(c)(1)). So simply because something is in the terms of service you sign, that does not mean it is valid or enforceable