2R, I agree, it has taken way too long for BIEL to become an option available to all chronic pain sufferers who would rather avoid the dangers of drugs to alleviate their pain.
BIEL does need a new 'Face of the Company' who is more articulate and can inspire confidence in investors. AW deserves the position of Chairman of the Board for his decades long battle to make ActiPatch available to US Chronic Pain Sufferers.
AW spearheaded the Reclassification, fought the FDA until they Granted ActiPatch Clearance, and pursued the NHS for 2 years until they saw the value in ActiPatch for their patients and their bank account.
I have 10 years with BIEL under my belt and would have sold long ago if ActiPatch did not do such a good job at relieving my back pain. I felt that in addition to making a return on my investment everyone deserved the option of choosing drug free pain relief.
However BIEL was bucking the multi billion dollar Big Pharma establishment who was not going to share their monopoly on the pain killer market without a fight. Their influence, through the hundreds of millions of dollars they pay the FDA in new drug application fees, stalled BIEL's efforts in the US for many years.
Have you ever looked at the original BIEL 510k for the Actiband? It was submitted on 7/23/2002 and Cleared on 8/8/2002. That is right, the FDA Cleared Actiband in less than 3 weeks for the indication of treatment following Blepharoplasty, eyelid surgery.
Biel was safe and effective for use on the eyes, an inch away from the brain, but could not get Clearance for anywhere else on the body for 15 years.
The Actiband Clearance was a stealth mission, flying under the radar of the Big Pharma Oligarchs. Once they got wind of it they let the FDA know that they were not pleased.
It took the Goodwin Proctor Law firm, with a staff of former FDA lawyers, to threaten a lawsuit in order to gain the 2/3/2017 Clearance. That is what all of those FDA meetings were about at the end of 2016 with high level FDA Management. BIEL's lawyers saying, ActiPatch is entitled to Clearance, grant it or we will see you in court.
Did AW make mistakes, of course, but the fix was in to deny FDA Clearance to BIEL.
I did not think anyone was close to eclipsing BIEL in the OTC SWT Pain Relief Market before the NHS inclusion, and now with the NHS paying for ActiPatch that feeling has been extremely confirmed.
If the SEC confirms their initial decision before the Supreme Court agrees to hear the case concerning Unconstitutional SEC Judges BIEL will file an Appeal with the US Federal Court of Appeals. The Appeals Court specifically looks for issues such as, inadequate time for the defense to prepare, which is exactly what the SEC Judge did in only allowing a 1 week extension when 30 days were requested, not to mention limiting the response to 3000 words. The defense has a right to state their case. It is the Judge's job to hear them out if it 3,000 words or 30,000 words
Some would like you to believe that a final decision supporting the initial decision is days away. With the US Solicitor General and the Federal Appeals Court abandoning the SEC Judges the odds are now in BIEL's favor.
