To rapidly advance from laboratory experiments to clinical trials in Type 2 Diabetes based on "shortcut" regulatory routes, that enable a shorter time from the lab to treating patients.
Our initial focus is on a leveraging FDA 505(b)(2) designations and Expedited Pathway programs.
Based on our extensive investigation of pathologies, across multiple animal models, where the metabolism had become dysregulated (i.e. inflamed, iron overloaded and/or infected with bacteria), our PLATFORM has proven successful and effective in treating each of the shortlisted diseases chosen.
The shortlisted diseases were chosen based on technical and commercial criteria and market feedback, including Modes of Action Fit; Need – Orphan (mid-high range); Existing Drugs; Market – Size; Cost of Alternatives (if any); Pipeline of New Drugs in Clinical Trials; Physician – Initial Feedback from “field"; Payers willingness to pay for Treatment, Pharmacoeconomics; Duration of Clinical Study; Patient Availability; Study Design; and Regulatory Consultants Input.
After successfully working with the regulator and other market players and bringing a drug to market, we will pursue the "common" regulatory approval routes for other wide spread indications (such as Psoriasis) with blockbuster drugs.
Our focus leverages the global demand-creating patient population of about 450 million people with Diabetes.
Our drug for treating Type 2 Diabetes drug (Pill) – extensively demonstrated as effective in both prevention and treatment of T2 Diabetes – by Restoring Insulin Resistance to Normal Levels! Markedly inhibiting the appearance and the degree of hyperglycemia; lowering LDL; lowering body weight; reduction of cataract formation and diabetes-induced retinopathy