Our Strategy: Faster and Cost-Effective Development
The business model of developing new uses for already approved products allows us to fast-forward the early development and preclinical studies and go directly to human (clinical) studies, i.e., the 505(b)(2) route.
A 505(b)(2) NDA route allows the sponsor to use the preclinical studies and some safety and chemistry data from the innovator's NDA, hence it is a much faster and cost-effective drug development route compared with a traditional development path [such as 505(b)(1)], while also creating new and differentiated products with tremendous commercial value.
The current plan is to conduct proof of concept studies (Phase 1 or 2 studies) after the ideas are patented in order to prove that the new use is safe and effective in the intended patient population. During or after the proof of concept studies, collaboration or in-licensing opportunities with other pharmaceutical companies will be considered as a path to move ahead toward commercialization of the products.