Biotechnology company developing innovative first and second generation novel compounds therapeutics to treat addiction and mental health Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) has been granted approval by the U.S Food and Drug Administration (FDA) and U.S Drug Enforcement Agency (DEA) to cultivate psilocybe cubensis and synthesize five schedule I compounds in the United States under the schedule I research license.
Following this approval, Mydecine will become the first vertically integrated US biotechnology company utilizing psilocybin-based psychedelic medicine. Additionally, the approval enables the company to strengthen its control on the US supply chain and protect its development and expansion of intellectual property (IP) in a better way.
“We are so excited that the DEA has granted us approval to synthesize our own APIs and grant us the approval to cultivate Psilocybe Cubensis mushrooms inside our laboratory in California. As far as we’ve seen, this is the first time a company has ever been approved by the DEA and FDA to cultivate and grow these mushrooms in the United States. On behalf of our entire company, I wanted to thank the DEA and FDA for their continued efforts in allowing Mycrodose the ability to further our research into finding alternative ways to help the millions of patients suffering unnecessarily,” said the company’s CEO, Chad Conner.
This approval allow the company’s scientific team to expand and create novel IP as they better their manufacturing processes, improve extraction technologies, synthesis and stabilization technologies and enhance the safety and bioavailability of their major advanced drug delivery (ADD) technologies.
The company’s ADD technologies allows smarter delivery systems which create better safety profiles, enhanced availability and require less active pharmaceutical. This gives the company the ability to meets the needs of children and the elderly.
“We continue to push our research and product development efforts to even higher levels of scientific integrity and scrutiny. This additional DEA license furthers Mycrodose’s vertical integration and widens our foundational capabilities, in particular freeing us from supply-chain constraints. Having access to unique API’s produced under cGMP will open our work to further novel intellectual properties along the lines of cultivation, extraction, novel therapeutic indications and associated delivery technologies. We strongly believe that taking this much harder route is the smarter way to grow and protect our intellectual property portfolio. In addition, by keeping this sensitive info and work effort in-house, we will save millions of dollars in R&D costs,” said the company’s CSO, Frank Kochinke.