The central part of our comprehensive development plan is to transition our intervention to make it available to the society during this COVID-19 pandemic through carefully planned set of clinical trials, progressing from the proposed Phase II “proof of concept”, and then to the later trials where more patients can benefit from the result of this trial. Clinical trials are often the most expensive and rate-limiting part of a program, so considerable effort goes into designing trials that are both necessary and sufficient for regulatory approval and market success. The proposed trials will also provide the data for phase III clinical trial.
The next phase is to expedite phase IIB and phase III trials (estimated 12 months for completion) and post marketing phase (estimated 8 to 12 months for completion). Organicell Regenerative Medicine University Miami – Life Science & Technology Park 1951 NW 7th Ave – Suite #300, Miami, FL 33136 info@organicell.com www.organicell.com Phone: (888) 963-7881 Fax: 1-786 472 7020 Depending on trial results, if strong efficacy is confirmed, we will pursue FDA’s accelerated pathway to obtain 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.
Our team will develop a comprehensive plan to evaluate all aspects of marketing the product and training the diverse array of stakeholders who will be the ambassadors for the new product. The plan will include a strategy to address the specific needs of a marketing plan, training of medical professionals, documentation, and other pertinent printed and online material for patients and general audiences.
