SGN NanoPharma believes that the drug delivery business and the MNP technology represent a real value proposition due to the shortened regulatory pathway that lies before the products under consideration and the types of products that can utilize this technology.
In general, most reformulations and re-purposed drug products can be approved in India and semi-regulated markets fairly quickly (6-18 months) and will be subject to a 505 (b)(2) regulatory pathway in the USA, due to the inherent safety record of all ingredients.
SGN already has one MNP product approved by the US FDA as a 505 (b)(2) product (Estrasorb) from the MNP Technology Platform.
Utilizing these regulatory pathways for approval would allow us to bring a product to market in a shorter period of time in the US than an unapproved, novel active pharmaceutical ingredient (2-3 years versus 7-10).
The regulatory pathway for Cannabinoids follows that of a traditional novel API, and the clinical candidates have to undergo Phase I, Phase II, and Phase III studies. However, some of the early stage studies can be conducted outside of the US, decreasing the time and cost associated with the development.