Premier Biomedical, Inc. CEO Letter - December, 2017 - Seite 2

• Of the several patents that Premier Biomedical has licensed (three issued patients, one European PCT, and approximately ten pending patents), one issued patent covers the unique combination of two synthetic ingredients believed to be an extremely effective pain formulation. Because these ingredients are synthetic, FDA approval will be required prior to market introduction.
• Our strategy from the beginning was to utilize our patented formulation for a pain relief product as a "cash cow" to fund the very expensive work in our Immunotherapy and Biologics research at UTEP.
• Our patented pain formulation consisted of two synthetic ingredients previously approved individually by the FDA. We approached the FDA seeking certification approval of the patented compound and were disappointed to discover that the required series of testing would entail up to two years of testing duration and up to $10 million in cost.
• Our alternate strategy was to seek off-shore partners to help finance the certification with their home country FDA with subsequent approval in the United States. The cost and timing to obtain certification presented a barrier to successful off-shore alignments.
• The most recent developments in the United States associated with opioid addiction -- 28,000 opioid-related deaths annually in the U.S. alone -- dictated our latest strategy alternative to enter the blossoming pain management market in the United States using all natural ingredients, 50-state legal, opioid-free products that do not require prior FDA approval.
• The obvious problem was our entry into this market required expertise, capital, and experience that we did not possess. To overcome this shortcoming, we engaged in a search for an ideal partner and were fortunate to form a joint venture company with Advanced Technologies Solutions in San Diego, California. The Managing Director of this business, Mr. Ronald T. LaBorde, had developed a CBD-based, opioid-free, 50-state legal, all-natural ingredient formulation which precisely matched our goals.
• Our current business plan is to offer our patent-pending, 96-hour pain relief patch, which we believe is the best in the industry, and a roll-on applicator, for sale on our website, www.painreliefmeds.com, beginning January 2, 2017. Additional pain relief products, including creams, sprays, gel pens, and capsules/pills (Pain-Ex™) will follow later in the year.
• Our marketing plan recognizes the fact that pain relief/management products are intended to help chronic pain sufferers, such as the elderly and current and past contact sports participants. With our limited budget, we have decided to focus on advertisements in Central Florida and in players' association publications. We have also distributed sample products to the Arthritis Foundation in Northern Florida and select healthcare professionals as well as other contacts in the pharmaceutical industry. We will continue to attempt to seek possible distributions through established pharmaceutical and other retail outlets.
• Incorporation of our patented synthetic pain management components into capsules/pills will most likely require FDA approval and be marketed under the name Pain-Ex2TM.
• We are particularly excited about entering into this pain management industry, as the current world market for this entire segment of the healthcare industry is $112 billion annually!
• Ronald LaBorde and I attended a cannabis industry conference in Las Vegas in mid-November of 2016 which was attended by over 10,800 people and included almost 400 exhibits. Just a few years ago, there were only 420 attendees at this conference, so this is an industry with explosive growth potential.

Organizational Revisions.