I pasted some new development about Bioelectronics below. The post is from the company by way of srinsocal from the I-hub message board. I italicized and bracketed their comment with parenthesizes.
The marathon continues.
One positive takeaway is the FDA has agreed to review data already submitted for the 510K for musculoskeletal pain, especially back pain. This possibly indicates some forth coming closure on the back pain application since it would indicate the submission is complete.
This stock needs a win, and it would be very good to get FDA approval for at least one application, as all else would logically follow even if more data is required for the other ones, specifically knee and plantar fascitis.
BIEL’s management was smart to engage lawyers to help navigate this thing. Maybe that will make a difference this time. There are only so many ways you can crunch numbers, and the FDA must be great at this, so for back pain at least, we may expect closure in a reasonable time, or at least I can’t see why we wouldn’t. I bought more.
“Pending U.S. 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.
Senior Management once again attended meeting showing that this is still an important priority project for the FDA
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.”