Bioelectronics Corp (BIEL)

[TruthBeSaid]

You got it wrong on clinical data Pink:

"... They have failed, for years, to produce meaningful clinical trial data to support clearance. This is either due to incompetence by BIEL management (best case) or because the device doesn't actually work (worst case)..."

The first sentence is not true (and the first part of the second I wont quarrel with so much). They have produced very meaningful clinical data. Please don't join Fuente in spreading falsehood about clinical data. I certainly thought you knew better, apparently not. I urge you to read this paper carefully and come back on clinical data:

http://rheumatology.oxfordjournals.org/content/early/2015/12/23/rheumatology.kev426.long

FDA have asked for clarifications on the clinical trials and registry study data, which is not uncommon. That implies that FDA thinks more of the meaningfulness of the clinical data than you do. Again, please try to understand what the paper reports. And on OTC, they are saying a different pathway is needed - unfortunately FDA pretty much never clears a device or approves a drug for direct OTC. It has always been a few years of prescription based use. Bielcorp is trying to convince them otherwise. They may not may not succeed on that - but all is not lost without OTC. Prescription clearance is a great step forward, especially given what Braun is doing with the devices in the UK, which brings us to my next less direct point on clinical data.

You know that Braun has applied for listing in NHS Drug Tariff, which requires strong clinical data and a decision on this due any day now. Why and how would Braun apply if they do not have that data ? So, while the Barun data are not public, it is clear they exist - they have said enough in the past to indicate this:

(1) "...Orthopedic surgeons who are using RecoveryRx see a significant clinical benefit,...” commented Phil Cleary, Senior Product Group Manager, B. Braun Medical Ltd. This is the culmination of the 2015 partnership

(2) "...The companies also stated, as part of their working relationship, that B. Braun would be conducting further randomized controlled studies in its UK centres of excellence in knee arthroplasty and bone healing."

(3) "... After clinical testing, B. Braun Medical Ltd recognised the broad application of RecoveryRx® technology in orthopaedics - from joint replacements and spinal surgery to fracture management - as well as its ability to provide effective pain relief and decrease fluid retention, which in turn may decrease the length of the patient’s hospital stay and improve functional outcomes."

B Braun is a seasoned player and a world leader in hip and knee replacement and they are wanting NHS reimbursement for the ReoveryRx patches included in their surgical kits. Are you suggesting you know better than they do ? Again please read the Rheumatology paper. The results are far out.

Lack of meaningful clinical data is a figment your imagination.