Ease of acceptance by the medical community, Medicare reimbursement:
The potential lower cost of RadioGel therapy coupled with the potential very large number of patients satisfied this criterion. To further test the criterion, we are in discussions with a major private clinic with several skin treatment centers. This client believes this is a great new tool for their toolbox.
There are other cancer types on our list of eighteen potential indications of use for RadioGel, and we have already prioritized to present them to the FDA in the future. Unfortunately, in the meantime, those patients will not be befitting from this technology.
As I have reported in my last shareholder letter, I am aligning the veterinarian animal testing with the human skin cancer. Specially, the University of Missouri will be focusing on the treatment for surface soft cell lesions, and Colorado State University will be refining the therapies for oral squamous cell cancers.
After this selection, our next step is to prepare for the FDA pre-submittal meeting. We will request that meeting after we complete the test plans that will answer their previous questions. Until we complete these plans I can only estimate that our pre-submission to the FDA would be in June. I am really happy that we have engaged John Smith from Hogan Lovells to be at our side through this FDA process.
I am excited and relieved that this selection decision had been made and I wanted to thank the members of our Medical Advisory Board – Chairman Dr. Barry D. Pressman, Dr. Albert DeNittis, Dr. Howard Sandler, and Dr. Darrell Fisher. I would also like to thank Dr. Ricardo Paz-Fumagalli and Dr. Beau Bosko Toskich from the Mayo Clinic for their valuable advice.
In addition to the important developments discussed above, we continue to believe that the public markets are significantly undervaluing our company. With a fully diluted enterprise value of less than $10 million, there remains very large upside potential. As we progress on our plan, I intend to work vigorously to educate and inform the medical and investment community as to the therapeutic benefits our core technology as well as the economic model that can generate significant revenue and profits. We are committed to pursuing an uplisting to a national exchange as soon as possible in order to gain wider exposure and credibility in our pursuit of the multi-billion-dollar addressable market for Radiogel™, that can both significantly improve patient outcomes and reward shareholders.
Dr. Mike Korenko
President and CEO
