I am not sure if I am answering your question properly, but my opinion is that MindMed should concentrate on the science behind the compounds and keep developing IP.
Data Moats
If you’ve taken the time to look through any of the clinical trials being performed by these companies, you’ll notice that (for completed trials) the results are not published. This is different from how typical peer-reviewed trials are posted, where the results are public so that they can be scrutinized/verified by other labs. In BioTech, the results are kept under lock-and-key, creating what’s called a “Data Moat.” The results from these trials will be put together in a package that is presented to the FDA as justification for the safety and efficacy of the proposed IND (Innovative New Drug). The data and information from trials performed by one company cannot be used by another. Example: Compass Pathways cannot use the trial data owned by MindMed, etc.
Intellectual Property
The major players in the space, including CMPS and MMED, have as a major component of their strategy the development of proprietary molecules. The objection has been raised, “It’s still basically the same thing. All they do is put their own branding on it (i.e. proprietary Psilocybin molecule “COMP360” by CMPS”) While this may be true, the molecule is nevertheless a deviation from the naturally occurring one.
This is extremely important when understood in light of FDA requirements for competitors to begin producing generics.
“A generic maker must present laboratory evidence that its copy is chemically the same as the original, plus human clinical tests showing that the generic behaves like the original in the bloodstream. Now, half of all U.S. prescriptions are filled with generic products. Biotech pharmaceuticals aren't as easy to copy. They typically mimic the complex folded shapes of natural proteins, and the molecules of some biologics are thousands of times larger than a typical drug molecule.”
Let’s take COMP360 for example. Currently, would-be generics have NO access to this proprietary molecule. Once the molecule hits the market, and generics competitors have the chance to analyze it, they still have the work of having to reverse engineer it and figure out exactly how Compass Pathways made that molecule. Again, the molecule must be proven an exact chemical match in order to be accepted as a generic by the FDA. They can’t just say to the FDA, “Look, we both know that this is just Psilocybin with a fancy name.” That won’t fly.
The specific deviant of the molecule which is patented, the technology to mass produce that molecule, and in some cases even the patented delivery method—these are all hurdles that competitors/generics must overcome. The Path to Revenue
Typically, the above mentioned is all new BioTechs have. In the case of Psychedelic Assisted Therapy (PAT), however, there are additional layers of IP that provide further complications for would-be generics.
What these PAT BioTechs will be proposing to the FDA is not a traditional “Pill-a-day” regimen (microdosing aside). Rather, it is all the above Data Moated and Patented molecules also combined with Data Moated and Patented methods for therapy.
This means that, in addition to breaking through the typical barriers, generics will also have to prove to the FDA that they can administer therapy alongside the molecule in a fashion that matches the outcomes of the Company.
This is a very daunting outlook for generics and knock-offs. Consider how traditional “Pill-a-day” knock-offs can profit by producing and selling a drug through traditional pharmacies. In this scenario, that is not an option. They will also have to establish some form or fashion for delivering an entire therapy regimen.
Example
Let’s take an example where I think MindMed is doing a fantastic job. The thing about these compounds (LSD, Psilocybin, etc.) is that for most of the people, they are incredibly positive. However, when it goes bad, it goes really bad. We’ve all heard horror stories of a “bad trip.” Without a doubt, this industry has the potential to suffer terribly if this “problem” isn’t solved. So far, clinical trials have been largely positive. In my opinion, this is due to the participants in these trials being very, very heavily screened. Even so, there will still be some negative outcomes. Here’s an example from a recent Compass Pathways Phase 2b trial:
“Two patients treated in the phase 2b so far have experienced suspected, unexpected serious adverse reactions that may be drug related. One patient experienced adjustment disorder—symptoms that can occur after a stressful life event—that led to hospitalization. The investigator deemed the event, which happened more than a month after treatment, to be of moderate severity and possibly related to the drug. Another patient was hospitalized with suicidal ideation.”
Back to MindMed. MindMed is engaging in clinical trials which combine both LSD and MDMA. In this case, LSD is the “healing” component, while MDMA acts as a “hedging” component (LSD causes the “trip,” while MDMA produces overwhelmingly positive emotions). Further, MindMed is producing proprietary software which calculates how much of each of these compounds, and in what proportion is given to the patient. Even more, MindMed has also patented a “trip killer” drug, which gives the accompanying therapist and/or patient the discretion to end a trip. It is impossible to overstate how important these developments are for securing a path to revenue. We already know that high doses of these compounds will not be approved by the FDA without accompanying therapy. Companies like MindMed are securing a path to revenue by creating a proprietary “package” of care to be approved by the FDA. Not just another compound.
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