Business Strategy
Cortex has two go-forward strategies: an internal and external strategy. The internal strategy focuses on the development of several new uses for AMPAKINE products that lend themselves to “Orphan Drug” indications, e.g., Narcolepsy, Fragile X syndrome and Sleep Disorders associated with excessive daytime sleepiness. The external strategy is to complete one or more “financially sound” partnership(s) with a major pharmaceutical company(s) to develop the remaining AMPAKINE compounds for indications that require large, expensive Phase III clinical trials, and, ultimately, large sales forces to achieve significant market penetration. These disorders include Attention Deficit/Hyperactivity Disorder (ADHD), Alzheimer’s disease, Schizophrenia, Depression, Parkinson’s disease, Post stroke , Traumatic Brain and Spinal Cord Injury and possibly Respiratory Depression, unless Cortex commercializes that indication.
The Company plans to develop compounds internally for a selected set of indications, many of which will allow us to apply for “Orphan Drug” status. Such designation by the Food and Drug Administration (the “FDA”) is usually applied to products where the number of patients in the United States (“U.S.”) in the given disease category is usually less than 200,000. These Orphan Drug indications typically require more modest investment in the development stages, follow a quicker regulatory path to approval, and involve a more concentrated and smaller sales force targeted at selected medical centers in the U.S. The key indications that the Company plans to pursue internally include some of the following disorders: Huntington’s disease, Fragile X syndrome and Rett’s syndrome to name a few.