BIEL submitted its new 510(k) application on August 6, 2015, couple of months ago, at both the recommendation and the invitation of FDA in 2015 How do I know? Have that communication in my possession. Said application falls into a new FDA device category, containing new survey and trial data, all under the supervisory umbrella of the new reclassification project commenced by FDA on February 20 2014 wherein FDA stated, “FDA is issuing this Proposed Order on its own initiative” and, “based on new information”. Facts.
ActiPatch continues to rule at the top of the heap at Boots UK, a wonderful and unbiased barometer of consumer acceptance and market penetration.
My personal opinions with respect to the company BioElectronics and its stock, 'BIEL' are these:
Thinly held, tiny, US developmental company, with no money to spare and appropriately requires FDA regulatory approval for ActiPatch, its patented cornerstone product. FDA has come a long way by publishing its Proposed Rule and is publishing its Final Rule next Tuesday to reclassify such devices as Class II from Class III following hundreds of comments from industry in the SWT space and other interested parties and more than two years work. BIEL and others in the SWT and PEMF space will apply for OTC approval, but BIEL is THE leader in the pain space with its patented, miniaturized pain devices.
ActiPatch works and is totally side-effect free – no addictions, no nausea, safe and efficacious. Many studies exist for the reading by those who wish to do so. I believe another BIEL product, ‘ALLAY’, for menstrual cramping and pain for tens of millions of American women suffering from these every month of their lives is a huge sleeper. No drugs, dealing with pain, side-effect free, inexpensive. These devices are already a disruptive technology! And there are other products and indications in the BIEL product line.
Shareholders have been extremely patient with the growing pains of the little engine that could. Common sense tells me the market cap must and will rise substantially on the publishing of the Final Order for reclassification and thereafter as milestones are reached and passed. What I do know is the market cap will be a substantial multiple of where it is now with ActiPatch as a Class II device for a host of indications. What will it rise to? Who knows.
The company has progressed incredibly well in the UK, in retail at Boots, other drugstore chains coming there and off the charts with Amazon UK, all proven by amazing sales results. It is moving forward in Canada, with great results at Amazon Canada and upcoming news about Costco and Walmart after several false starts up there. BIEL still sits patiently in neutral here at home where it cannot legally market and sell its products, yet.
By everything I see, the tsunami is coming, correction, arriving. What share price? 4 to 8 cents initially on the publication of the reclassification Final Order by FDA in the Federal Register, then a retracing, then at least 10 to 15 cents when OTC becomes a reality. What is that based on? Speculation of what I see as future reality on sales potential and market cap. No factoring in of market nuances and greed both of which could push it higher.
I expected the stock to run to north of 50 cents in 2009 short term, it topped at 12 cents because there were bad promoters on board, a guy named Noel as leader, who was convicted by the SEC and banned from involvement in public companies for life after charges involving different companies, not BIEL. Whelan threw the bad guys out, to his credit. Long term? Every drugstore in America, in 1/3 of American homes replacing the painkillers we now pop like candy. Why am I confident? Honest, solid information and correspondence. You tell me what the upside is. . . .
The product worked well for me on a serious sports injury, I bought stock in 2009 and took profits in the run that year, doing very, very well. The stock then imploded because of a few poor management decisions and the treachery by the scoundrels who the company threw out, all happening years ago. I observed as senior management threw the scoundrels out. Since then, the company has fought its way back, learned the regulatory game and stayed alive, openly declaring it was selling stock to finance its By everything I see, the tsunami is coming, correction, arriving. What share price? 4 to 8 cents initially on the publication of the reclassification Final Order by FDA in the Federal Register, then a retracing, then at least 10 to 15 cents when OTC becomes a reality. What is that based on? Speculation of what I see as future reality on sales potential and market cap. No factoring in of market nuances and greed both of which could push it higher.
FDA took charge as it should have by hiring the new people as it said it would to bolster its devices division. Then came the UK approval, Boots deal, FDA Proposed Order, Walgreens acquired part, then 100%, of Boots, Dr. Kotack appointed at BIEL, new 510(k) application submitted August 2015 as invited by FDA, competent law firm now involved, UofMaryland bioengineering students breakthrough study on PEMF treatment of bone fractures. A lot of credit will now go to Andy Whelan, BIEL CEO, an ex-US Marine, with a streak of stubborn Irish who just wouldn't quit. Nice story? Yup, this is America and there have been too many advances to list here. The tsunami is coming.
When will it happen? I've been saying soon for months, remember where you heard it. And then Americans will be able to walk into any Walgreens, CVS or Rite Aid and buy an ActiPatch or an ALLAY because that is how things should be for tens of millions the American people who suffer from mild, medium or severe chronic or occasional pain, for all the right reasons. It's not who is right, it's what is right and buying ActiPatch or ALLAY OTC when we want to is right. England and Canada are ahead of us on this one, but so what, we'll get 'er done and we just made up a lot of ground with the Final Order out on Tuesday.
Greetings to the Good Guys (and Gals) yamayama
A couple of my earlier posts, one a week before the announcement of the Final Order, the other the day before. . . .
55648 October 2, 2015
So living in the past. It's 2015 and BIEL and other manufacturers are going to get FDA reclassification of their devices as Class II from Class III as 'the' major breakthrough toward approval for sale of the devices here in the US.
Those against the FDA reclassification and emergence of ActiPatch type devices and the eventuality of major reductions in the epidemic consumption of harmful, addictive chemical pain management drugs either still use an abacus, write snail mail letters, use lanterns, rotary dial phones, buses to go from NY to LA, keep travel locally by horse and go to bed when it gets dark. Not my issue, I am only interested in 2015 and the future of pain management using BIEL type devices instead of harmful drugs. There will always be a place for chemical drugs, but never again to the extent that Americans are consuming today. This is being proven now in England where tot OTC sales of ActiPatch are escalating through the roof.
Good luck with all the yesteryear. BIEL is here, it is an American company that miniaturized a scientific innovation that works and the UK was intelligent enough to endorse ActiPatch, Canada too, and it's already helping tens, hundreds of thousands in England to better and more safely manage their pain. Our approval process takes longer, part of the cost of doing business here, but the BIEL/ActiPatch/ALLAY train is coming to Walgreens, CVS, Rite Aid, Walmart and all the rest, soon!
55821 October 8, 2015
Like good wine, any breakthrough, innovative pharma/med treatment modality takes time, particularly when regulatory is involved. FDA is behind these devices, BIEL's are patented, safe, efficacious and miniaturized. FDA Proposed Order published in the Federal Register Feb 2014, public comments requested at that time and received and reviewed, Final Order in-process for publication designating BIEL type devices to Class II from Class III. BIEL's new 510(k) submitted August 15 at suggestion of FDA. The tsunami is coming - soon. Big patient smile. Yamayama.
Soon is here baby!!! Yamayama
Authored by a good friend of mine and a real Biel Die Hard GoodGuy Thank you....Not exact but close LOL
News 
Market Data 
Discover 
