The core of our comprehensive translational plan is to develop our intervention as an available treatment option for society during the COVID-19 pandemic and any future pandemic. This plan includes the completion of necessary pre-clinical and clinical trial testing of our novel biologic in order for advancement to market. Conducting well designed clinical trials is often the most expensive and rate-limiting part of a translational program, however, is necessary for the regulatory approval and market success of therapeutic biologics. By following a carefully planned set of clinical trials, we plan to progress from our proposed Phase I/II “safety” and “proof of concept” trials to large Phase III trials where a greater number of patients may benefit from the results of these trials, and eventual FDA approval may be obtained.
Our immediate next phase is to expedite the approval of Phase IIB and Phase III trials (estimated 12 months for completion) and post marketing phase (estimated 8 to 12 months for completion). Depending on trial outcomes, we will pursue FDA’s accelerated pathway to obtain a Biological License (BLA) for the use of Zofin™ for COVID-19 patients. These pathways are: 1) Breakthrough 2) Therapy Accelerated Approval 3) Fast Track and 4) Regenerative Medicine Advanced Therapy Designation.
In the event of product approval, our team will develop a comprehensive plan to evaluate all aspects of the market. This plan will include a strategy to train a diverse array of stakeholders who will serve as product ambassadors, the training of medical professionals for product use and documentation, and the generation of other printed and online material for patients and general public.