For Newbies, This Is What It's All About:From December 14, 2020, NR:
While the medicalization of psychedelics is evolving and gaining momentum at an extraordinary pace, such therapeutics still face regulatory hurdles in the areas of manufacturing, formulating, and ultimately dispensing or the rescheduling of Schedule I drugs to patients. Attaining the goals of any given psychedelic-based endeavour will require the removal of federally scheduled enforcement status and global United Nations drug conventions of which the United States and Canada are both participants. Authors of "An ethical exploration of barriers to research on controlled drugs" in the American Journal of Bioethics have been quoted stating, "the classification of drugs as Schedule I amounts to an unsurmountable barrier to research." LSD has been federally scheduled since 1970, and the rescheduling progress is subject to the FDA's abuse potential assessment that will include an analysis of the 8 factors of the Controlled Substance Act. It is important to note that rescheduling, while removing a substance from Schedule 1, still implies a reduction to a lesser schedule, not a removal from the Controlled Substance Act (CSA).
“BetterLife’s acquisition of Transcend’s intellectual property allows us a rapid pathway forward to drug manufacturing and human clinical studies without the regulatory hurdles seen elsewhere in this industry,” stated Dr. Ahmad Doroudian, Chief Executive Officer of BetterLife. “With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades. Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”
Patrick Kroupa, Transcend’s President shares, “Having spent decades working with psychedelic molecules which are remarkably effective at addressing addiction and mental health disorders, it can be heart-breaking to witness the disconnect between what is, and what should be. The regulatory hurdles and barriers associated with administering psychedelics to human subjects are staggering. I'm very excited by the opportunities presented by BetterLife's experienced clinical research team enabling Transcend's novel therapeutics to reach human beings in need of help.”