Frederick, Maryland, Dec. 04, 2018 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Dear Fellow Shareholders,
While we were all disappointed by the dramatic drop in the stock price, it hasn’t had an impact on the Company’s operations.
What is still needed is a cost-effective efficacious painkiller that is also an alternative to opioids. Physicians prescribe, and patients take opioids because they do not have an alternative painkiller. Back pain and post-operative pain are the major uses of opioid. BioElectronics products work when nothing else does because it is The New Technology for Pain Relief.
The FDA did two things last week that panicked investors:
1. It refused to accept our explanation on why we had adverse findings on some of the men in our new, unnecessary, and “free” clinical trial. We submitted more than adequate evidence in four previous studies, the foot, the knee, 4,539 back pain users from our UK Registry, and the pectoral muscle in the breast augmentation study. We will resubmit the data in a new 510(k) application and request an indication for women only.
2. The FDA dedicated itself and its $5+ billion-dollar budget to assist in the development of eight opioid sparing projects, or 3% of the 250 projects submittals. We were included in the 97% of rejected applicants. We have the FDA’s pre-submission approval and will submit our post-operative pain relief application, to help mitigate opioid use.
We are going to stay the course and;
1. Immediately file the new 510(k) applications for musculoskeletal and post-operative pain.
2. File the 510(k) application for Allay and continue our research on migraines, over active bladder, pelvic and phantom pain.
3. Continue discussions with the 5-active major pharmaceutical potential marketing partners.
4. Complete our 8th country deal and aggressively support the seven existing countries with Mundipharma.
5. Continue our marketing support of the UK B. Braun same day hip and knee replacement program and detail healthcare professionals to write reimbursable prescriptions.
6. Focus on getting the new insole product on the market.
7. Fine tune our reimbursable sales and marketing to the VA, the military, nursing homes, and hospices patients.
8. Dispose of the SEC’s case tried by an Administrative Law Judge who in 50+ cases over eleven years never ruled against the SEC.
9. If necessary, we will get a knowledgeable healthcare investor, in the absence of a major marketing partner.
Thank you for your continued support.
Andrew J. Whelan, President