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Saturday, October 24, 2026

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@kevin__mak

Kevin Mak on X

I think the main consideration with the CDER appointment/publication is that it narrows the gap about "Does COMP360 get approved?" Basically the situation gets de-risked by some %. I've seen some analysts suggest the probability of approval is around 75% (which I think is way too low), my estimate is in the 90%+ range. It would be extremely weird for the FDA/CDER (and White House) to give all of these "pro-psychedelics" signals to the public, and then turn around and immediately decline (or hamstring) the highest profile, most time-sensitive drug application. To be clear, this is not 100% chance of approval, because there are ALWAYS risks/weird things that can happen, but directionally, this moves in the right direction (and the recent stock price move partially reflects that). But my opinion, as I've said before, is we've got a long way to go before the market price truly reflects the opportunity for $CMPS.
@kevin__mak

Kevin Mak on X

$CMPS Lots to be excited about for the company and the space. Specifically there's been a lot of "thematic" interest in the psychedelics/psilocybin space in the last few weeks, and I expect that to continue. The most notable event recently is an article published in the New England Journal of Medicine: "FDA's New Framework for Psychedelic Drugs" (paywall) https://t.co/rdkgp5GsOG This was co-authored by Michael Davis (just named permanent director of CDER) and the FDA's top psychiatry and neuroscience reviewers. They're the group that ultimately approves/rejects COMP360 (and other psychedelic drugs). Aside from approve/reject, they will be helping negotiate/decide the "label" and essentially how permissive or strict the availability of these drugs/therapies are. The devil is in the details and hearing the FDA publicly state that they are aligned, i.e. "let's make sure these drugs get to market safely AND effectively" versus "this is weird/different, lets be extra cautious/slow with the roll out" is very important to both shareholders, and patients who could potentially be helped by these therapies. Another interesting article is here: WSJ: "Elon Musk's Inner Circle is Pouring Cash Into Making Psychedelics Mainstream" https://t.co/pfuE6JqBGD It is widely expected that COMP360 from $CMPS is going to be the first classic psychedelic (Psilocybin) drug to be approved and commercially available. Despite this being "priced in" by people who follow markets (or the industry) closely, I believe there's a good chance there's a positive public reaction to the headline when/if it comes out in the coming months. More importantly, I think we're at the very early innings of a treatment category that will be highly beneficial to a group of patients who historically have not had great treatment options. My full write on $CMPS is below, I have a $45 price target: https://t.co/rVZOU3yIz6 Disclosure: Creek Drive and its affiliated funds does hold a long position in CMPS. Views expressed are current opinions for informational educational only, subject to change and are not investment advice or a recommendation to buy or sell any security. Investing involves the risk of loss and past performance is not indicative of future performance. See the disclosures link in bio for more important information.

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