Bioelectronics Corp (BIEL)

[srinsocal]

Good questions PashkaVI

From BIEL's Pre-Submission PR:

"The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what regulatory pathway should be followed to get market clearance. The focus of the May 9 pre-submission meeting was in discussing the FDA’s feedback on the clinical outcomes and statistical techniques used in reporting the back-pain study."

"Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain."


I am speculating here but maybe that is why BIEL took the Pre-Submission route. To see if any red flags were raised when the FDA reviewed the Clinical Data. When the FDA gave them "positive feedback" BIEL could have understandably calculated that it was not an issue for the FDA. Again just pure speculation.

As far as Lawyers go, none were mentioned in the PR:

"The company was represented by their clinical R&D team comprising: Sree Koneru, Ph.D., VP Product Development, Ian Rawe, Director Clinical Research of BioElectronics, Kenneth McLeod, Ph.D. Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D. Professor Duke University."

I would hope this is something that would be considered by AW. As you may recall during the 2016 FDA Meetings there was an initially decision that BIEL did not agree with. BIEL's legal team, who had years of experience working inside the FDA, had to forcefully push back against the FDA to show them they were wrong. The FDA reversed the initial decision and the 510k continued to Clearance for the Knee and Foot.

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/