Real World Evidence (RWE) Drug Development: A Faster/Cheaper Route For Psychedelics
Written by Jeff Nielson,
Psychedelic Stock Watch
– Formal drug development through clinical trials is a long and expensive process
– As the Mental Health Crisis spirals out of control, people need access to psychedelic-based next-generation mental health therapies today
– How RWE drug development can accelerate the Psychedelics Revolution
The Mental Health Crisis is a healthcare catastrophe in desperate need of a solution: psychedelic medicine.
The problem in supplying this solution – via the emerging public companies in the psychedelic drug industry – is twofold. First, drug development via the clinical trials model is a very slow and very expensive process.
Secondly, the current irrational and obsolete classification of these drugs as Schedule 1 substances (that supposedly have no accepted medical uses) is further slowing down drug development.
MAPS is in the process of repeating its very successful Phase III clinical trial on an MDMA-assisted therapy for PTSD. It’s forced to do the trial twice because of FDA rules regarding Schedule 1 substances (the most-restrictive classification).
Meanwhile, every day of additional delay in getting this therapy approved, another 22 U.S. veterans will commit suicide due to their poorly treated PTSD.
Wouldn’t it be nice if there was a different “path” to drug development (and approval) that was not only faster and cheaper, but allowed commercialization to begin concurrent with development?
Present that teaser to an investor in psychedelic stocks and there would likely be two responses:
a) Sounds too good to be true.
b) There must be a catch.
In reply to that: (a) no, it’s not and (b) yes, there is.