Lots of investors are picking interest in the psychedelics space, and one of the biggest questions on their mind has to do with the stance of the U.S. Food and Drug Administration (“FDA”) since this organization is the gatekeeper (so to speak) of any therapeutic product intended for human use.
As you may already know, the FDA carefully reviews the data presented after studies are conducted. The purpose of this review is to establish whether the therapeutic compound or treatment modality is suitable for the condition targeted.
Since the FDA is a federal government agency, it is obliged to bear in mind all existing federal policies on drugs as well as the applicable regulations. By some coincidence, many psychedelic products are listed in Schedule 1 of the Controlled Substances Act, and this means that any drugs containing these substances will undergo the most rigorous screening before the FDA approves them for use by patients.
Interestingly, the legal categorization of psychedelic substances notwithstanding, the FDA doesn’t seem to be so hostile to these products in the same way as other agencies, such as the Drug Enforcement Administration (“DEA”).
Rick Doblin, the executive director and founder of MAPS (multidisciplinary association for psychedelic studies) revealed during an online event that MAPS sees the FDA as a partner during the design and construction of clinical trials involving psychedelic substances.
Doblin says that in his view, the federal regulatory body has risen above politics and is immensely willing to assess the available science regarding a substance, especially its medical benefits, before making a ruling on the same.
This statement by Doblin isn’t casual talk, because MAPS is currently conducting a study of MDMA as a potential treatment for PTSD. This substance was granted a breakthrough therapy categorization by the FDA back in 2017, and MAPS plans on conducting its phase 3 clinical trials next year.
Not many investors are interested in MAPS since it is a not-for-profit organization yet investors want to put their money where they will get a return on their investment. MAPS accepts donations, grants and other forms of contribution for which a return isn’t expected.
The investment side of psychedelics saw a wave of excitement when Compass Pathways went public on one of the most senior stock exchanges in the U.S.
It is clear from the comments of Doblin that the FDA doesn’t perform its duties with any biases. Consequently, any firm planning on developing any therapeutic psychedelic products should take comfort in the knowledge that the federal “watchman at the gate” will evaluate their data objectively and either approve or reject an application based on its own merits.
Many companies are seeking to address the emerging needs in the functional mushrooms and pharmaceutical psychedelic space. Cybin Inc. (NEO: CYBN) is one of those notable firms. The dedicated team is working tirelessly to develop nutraceutical, pharmaceutical and psychedelics products.
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