Pending FDA Market Clearance for Over-the-Counter Sales
We had a second status meeting with the FDA on Wednesday, July 20, 2016. Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head of the Physical Medicine, and the project statistician were present. The meeting went well and the tenor was very good.
Our knee and plantar fasciitis studies, and our explanation of our unique mechanism of action have been accepted as indicative of musculoskeletal pain relief. The examiners have also agreed to review our UK Registry back pain data to accommodate our broad relief of musculoskeletal pain indication of use request. We have excellent data on approximately 4,500 back pain users, as well as well as observational study data on 100+ subjects demonstrating the durability of the therapy over 6-months.
We believe the data will be acceptable in lieu of a controlled clinical trial for back pain to support an over-the-counter musculoskeletal pain indication through the premarket notification process.
BioElectronics Expands in the UK Market
Leading UK Retailer, Superdrug expands from 186 to 432 stores. Superdrug is a subsidiary of the A.S. Watson Group, the world’s largest international health and beauty retailer with 12,000 stores.
WHSmith, a British retailer founded in 1792, www.whsmithplc.co.uk has agreed to stock and sell our ActiPatch products in their 126 hospital stores. WHSmith currently operates over 1,300 convenience stores.