The Story So Far
There are about thirty years of backstory to this project which you should read about either in Dr. Moss’ book, or for a quick overview, in the excerpts section on the brain-tools website. The part where we (braintools) came into the picture, however, was in October of 2012. Dr. Moss and Dr. Summerton had already agreed to collaborate on finally turning the drug Dr. Moss had developed and tested into a workable treatment for memory loss in Alzheimer’s patients. The trouble that’s faced Dr. Moss over so many years was the lack of patent protection afforded to the MSF drug, making it cost-prohibitive for any big pharmaceutical company to carry through a 100 million dollar phase three clinical trial, despite its unprecedented efficacy in restoring the memories of Alzheimer’s patients. Dr. Summerton had discovered a long forgotten congressional bill called the Orphan Drug act, passed in 1983, which was developed for the specific purpose of getting highly useful, but non profitable drugs on the market. The bill was originally developed to cover drugs that treated life threatening illnesses that affected a very small patient base like Muscular Dystrophy, but since has been expanded to cover any drug that can provide great social benefit but not enough profit to cover the costs of clinical trials. The Orphan Drug act mandates that the FDA collaborate with drug development groups to help minimize the cost of clinical trials and streamline the process, while simultaneously offering a seven year guarantee of protected market status to help recoup losses. For us this ends up being four years of market protection as phase two and three clinical trials are expected to take about three years.
Because major pharmaceutical companies have passed on the drug, we at brain-tools may be the last hope to get MSF (Methane SulfonylFluoride) into the market. Our plan is discussed in detail here, but the key element is the reliance on crowd funding instead of a traditional equity investment. With funds raised through contributions we will not be accruing large debt to venture capitalists. Between this and the reduced costs of clinical trials through the Orphan Drug Act we can offer a contractual guarantee that we will keep prices of MSF affordable to everyone, even those without health insurance or on social security. This is a guarantee that other avenues of drug development cannot offer. Perhaps an even bigger advantage of this method is that it will open the path for other companies to follow a crowd funding/Orphan Drug act model, allowing other potentially lifesaving drugs that have fallen through the cracks to make it into the market.
It’s an exciting prospect, to say the least.