Clinical Trials

Clinical efficacy is generally demonstrated through a three step process.

1. Anecdotal clinical and market research. Distribution to a number of appropriate individuals who provide feedback on all aspects of the product, e.g. taste, appearance, effectiveness, value, packaging, and the like. While not scientific, experience has proven that results so obtained are valuable on many fronts, and sufficient to gauge the commercial viability of products.
2. Initial clinical trial. Third-party center performs randomized, placebo controlled, double- blind study with a minimum of 30 patients completing each side (placebo and active drug). The results are statistically analyzed, followed by publication.
3. Larger and/or more prestigious follow-on clinical trial. This trial is similar to the above. It will ideally involve a well-respected medical facility or physician group, and may sometimes involve more than one testing center. Protocols and controls are more rigorous and results subject to additional statistical analysis. These results should then be published in a well respected medical or scientific journal.

The Federal Trade Commission (FTC) regulates OTC product claims. Generally, a product must show efficacy in two separate clinical trials before it may be advertised as “clinically proven”. As noted, “clinically proven” products are the exception in the OTC marketplace, and have a history of performing extremely well. The value of clinical trials cannot be overstated.

A clinical trial by a well known institution can generate a tremendous amount of free publicity for the Company. The awareness and credibility associated with the release of favorable clinical results can propel product into retail outlets with speed and without many of the costs (slotting fees, etc.) normally planned for. Lower product liability rates are another benefit of performing clinical trials.

Provided the presently ongoing clinical trials generate favorable results, of which the Company is highly confident, the Company will become immediately well known, along with its migraine product.

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