>>>They have accepted our knee and plantar fasciitis studies as indicative of musculoskeletal pain relief and our explanation of our unique mechanism of action. However, they would like a third study to substantiate our broader indication of use. To accommodate our request for market clearance for the relief of musculoskeletal pain, the examiners have agreed to exclusively review the back pain data from our UK Registry studies. Some of this data is peer reviewed and published. We have approximately 4,500 subject’s responses, who used the trial device for musculoskeletal back pain, as well as data on over 100 subjects demonstrating the durability of therapy over a 6 month study period for back pain.<<<
How can anyone find negativity in this report to shareholders. It is one thing to not trust the honesty of management, therefore not trusting the context of this message, but to take it as fact, one who has an open mind must see where this is headed with the working relationship now evident between the company and the FDA. Maybe some needed to be following this back in the day, and then they would appreciate HOW FAR this relationship has progressed between the company and FDA. It is very evident, from this update, that the FDA through acceptance of previous trials and requesting (guiding the company) for a third trial to broaden the scope of intended usage, that they ARE POSITIVE in their behind the scenes conversation and evaluation of the product. Seems to me they ARE at the point of documenting and labeling "where to use"; "for what to use" and "what NOT to use for" (restrictive usage) of these products as per their request for third trial to BROADEN INDICATION OF USE. IMO, and I am hoping, they are excited about these products and working WITH the company and its medical advisers, through these meetings, to GET THIS DONE. FDA is very careful before they put their "stamp" on a product. Seems to me we are at the stage where they are conversing to do just that. If we conclude a third successful trial for the FDA, I envision that stamp of "FDA APPROVED" on every ACTIPATCH box sold worldwide!
