Archives for posts with tag: BIEL

Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.
Margaret Mead

Let me start with the beginning-Bioelectronic Shareholders need to proactively start spamming every article and tweet in the Internet Universe with news of The Actipatch, otherwise the window will close on the opportunity to get this effective and non-pharmaceutical pain relief product into the hands of people so they don’t have to use dangerous and addictive narcotics for pain relief.

Earlier I tried to post a rather lengthy rant, and somewhere between “publish and preview”, I lost the entire thing except the title. So I will try to recapture the essence of it, on a computer better suited for this than my phone, from which I tried earlier.

First, let me synopsize the current situation for Bioelectronics Corporation (ticker symbol: BIEL). After literally being in oblivion, the company, which produces a device which uses electrical pulses to control and alleviate pain as opposed to drugs, finally got a grossly overdue from the most corrupt organization in the world, the FDA. It was a case of the Steve Martin school of success–be so good they can’t possibly ignore you. Still, the FDA hedges, and only gave approval for 2 out of 3 510K applications. It’s a start, and the other one is pending.

Now, if you follow the news like me, you will see we “suddenly” have an opioid crisis in this country. I say “suddenly” in quotes because there is nothing sudden about it. The media and government are “suddenly” acknowledging the crisis, in article after article, presidential tweet after presidential tweet, the facebook, newspapers, magazines. This is from the same corporate government that brought us the Afghanistan War, replete with photos of soldiers from many nations guarding…poppy fields.  The Taliban had shut opium production down before 911, but thanks to the war, Candyland is open for business, and business is booming. So booming that it created a problem for Mexican drug cartels. You see, they had been supplying Europe with H, Horse, Smack, Big Brother, but now those pesky Afghans were back in business. American tax dollars at work. So where to sell Mexican cartel heroin? Idea!!! The USA!!!!

So they saddled up  a string of mules, etc.

Now, years later, Smack is Back, and people are dropping like flies. They got hooked on legal prescriptions and then “graduate” to street drugs when their prescription gets cut off. It’s the nature of addiction.

It even impacted the presidential election. Luzerne County in Pennsylvania is an extremely Democrat Machine environment, but it was dubbed the “unhappiest place in the USA” by the USA TODAY,  dubious distinction from an even more dubious newspaper. The reasons? The economy and the high rate of teenage opioid overdoses. Luzerne County voted for Trump. Easy to imagine this cost Hillary Pennsylvania. Dying didn’t get their attention, but not voting Democrat sure did.

Now, the reader needs to trust me. I am going somewhere relevant to the title of this blog, but now we need to take a brief dive into the Hegelian Dialectic, and how it will be used to subvert America’s recovery from the opioid crisis. Also, as a disclaimer, if you think pharmaceutical companies, Mexican Drug Cartels, or corrupt politicians care about you or your families at all, and have any real desire to improve your life at their expense, I may not be able to help you.

Here is the Hegelian Dialectic, which is used by our controllers as effectively as Shaq ever used the slam dunk technique:

A problem is created, or in the case of the Opioid addiction crisis, acknowledged and publicized. A solution is presented. It’s called synthesis and antithesis.

So, now that the mainstream is admitting the opioid crisis, what will be the solution we will be presented with? What solution will Big Pharma and their paid representatives in the Media and Government present us with? This is quiz time.What do you think? Let me know when you are ready. Done? Please put down your Number Two pencil. And the Answer is:

MORE DRUGS.

Yes, the solution to the drug crisis will be drugs to treat addiction. Margaret Hamburg, the disgraced former head of the FDA and her hedge fund husband manager at the Renaissance Fund are the types of people who run the FDA, and their solution to treat pain will be more drugs, drugs with dangerous side effects which will poison people. It an alley-oop. The Media and Government beat the Drug Addiction Crisis, and present the problem. Now we need a solution! Who will save us? The same “thinkers” who got us into this mess and made money doing it will now “fix” it, and make money doing that, except they won’t fix it, BUT THEY DON’T CARE!!! Kobe Bryant alley oops it to Shaq, and slams it into the faces of the American Citizenry, and a bunch of kids in Wilkes Barre are dead of drug overdoses at age fifteen. It’s the Hegelian Dialectic, and once you see it, you can’t stop seeing it.

So what can be done? A small group of people can make a difference. They sure as heck did in 1776. America is in a horrible crisis of opioid addiction and death. Bioelectronics, PEMF, pulsed microwave, The Actipatch is at least a partial answer. We Bioelectronic Folk own the cure. We provided the partial answer in 2009, but the crooks at the FDA smacked us down. In an absolutely humiliating turnaround, the FDA were forced to admit their gross mistake, albeit halfheartedly and grudgingly.

Now, politicians and media and whining about the opioid crisis. I wrote a series of books where this crisis featured prominently, the first in 2011, called ZOMBIE WORLD ORDER. I was writing about this six years ago. We own this issue, not the media, not the government, not the pharmaceutical companies. It is ours, we just need to claim it.

So I’m calling out to all Bioelectronics Shareholders, Actipatch users (who often become shareholders), and people who have suffered from addiction and the loss of loved ones to it. Fight back. Let’s start spamming the shit out of this. When Trump tweets about the Opioid crisis, there is an opportunity to promote the Actipatch. Every article can be used for such. It’s judo, we must use their weapons against them until we get our own. This can work.

There is a point in a chess match, an athletic competition, or a game of poker where decisive action at a critical moment leads to victory. We are at this moment. We must seize it as best we can and at every opportunity. We have an economic duty to ourselves, but more importantly, a patriotic and philanthropic duty to make America  a better place and make the world a better place. Drug addiction is demonic, a win for Entropy and The Devil, and all their minions. Let’s do this!

Image result for troops guarding poppy fields

Image result for troops guarding poppy fields

Image result for troops guarding poppy fields

 

Hello readers, best wishes on my star day, as they say in Dinotopia. Linked below are some books which should be free on February 18th. Enjoy, and as always, nothing wrong with reviewing the books on Amazon. The Zombie book gets more downloads, but my metered verse play is okay, though nobody reads it.

If you follow this blog at all, you may be interested in the Bioelectronics corporation, so I will address this timely topic. I’m not getting into charts and all that at this point–that stuff has merit, and the near term key resistance point in 0.003. 0.0018 was transcended last week, and the stock closed near its 52 week high today, at 0.0024.

Very solid week trading wise, as it appears like accumulation. I’m not even going to conjecture about this. However, on a radio interview last year, Mr. Andrew Whelan of the Bioelectronics Corporation predicted the Actipatch would be in Walgreens by January. This proved optimistic, as the Patch wasn’t approved until the very end of January, and the announcement was not till early February. However, point is Whelan has been working on getting this in stores, and this should be pretty imminent. So, on relatively light volume, the stock closed high right before a three day weekend. I expect news soon, to be blunt.

BIEL (Bioelectronics Corporation’s ticker) has developed a global marketing mechanism. BIEL is global. Now, a Glaxo or a Bayer would not need this structure, as they have spent billions developing their own. However, it has served as this giant marketing campaign to introduce the Actipatch to the world. There is a lot of value added to this buyout. I cite GLAXO specifically because they are a great and visionary company, and are already involved in the field of bioelectronics, though BIEL has bested them.

I admit, when I think of this unique, disruptive technology, I view Whelan as this OLD MAN AND THE SEA character, Santiago. He silenced all critics and caught the biggest fish in the ocean. Now he has to get the prize back to shore. However, now come the sharks and predators, too dumb to catch their own fish but will try to steal his. So say a little prayer for this tiny company who caught a whale. I think Whelan is a smart and experienced guy, and is pretty much holding a royal straight flush.

Allay, the Actipatch for menstrual pain, alone makes this a billion dollar company. I have eight sisters (big family) and can appreciate the magnitude of this idea and market. This will be a tough one to get FDA clearance for, but it will eventually happen. First, though, I am still expecting the Actipatch for Back Pain to get clearance soon. There were three 510Ks, and two got clearance. My question is will the Back Patch need to be refiled citing the two cleared as precedents?

Anyway, just checking in. Trump kicked some Commie ass at his recent press conference. True or not, I will always think Trump accelerated the approval process for BIEL just by scaring all the corrupt at the FDA. Hillary and her bag girl Margaret Hamburg were running it like it was an ATM for themselves. When I say BIEL is disruptive, it means this is like a water powered car engine would be for the oil business. BIEL’s technology may someday mean the end of the drug business, at least for pain management. If I get this, after reading primary research papers on this topic and doing some of my own data analysis, you better believe people a lot smarter and better financed than me realize BIEL’s potential.  They are not as honest as me though, and I believe they tried to bury this stock.

The thing about President Trump is that nobody can probably beat The New World Order, but you have to love the people who try.

I’m expecting great things in the near term for BIEL. In six months, the chart is going to look like a straight line up, though on the day to day it appears to rising slowly and gradually building momentum. I am going to theorize that BIEL is the kind of stock that had a lot of naked shorting going on. There may be a blowout top where they have to cover, and this might be an opportunity to try to flip some of the stock and buy back in (free shares). However, we are not currently there. It’s going up, but the stock is still so undervalued I don’t expect it to ever see these levels again once it shoots past them. We’ll see.

 

The Complete Zombie World Order Trilogy

Moonlight on the Post-Apocalyptic Dinner Theater

 

Pasted below are some good comments I’m linking to that give a good status synopsis for Bioelectronics World.

To add to the comments below by an art2426

The stock (BIEL) spiked since a couple of their products got cleared for OTC (Over the counter) by the FDA. Backed off a bit, but this isn’t over. News drives this stock, and I cannot stress this enough–FDA clearance opens up a lot of vistas for news, such as licensing deals, partnerships, new 510 K applications that now have a previously approved medical device to use as a precedent, and Buyouts.

 

From art2426

 

“>>>Whatever happens, it is going to be nothing but positive going forward. This company reached its ultimate low point before they were finally granted OTC clearance. We should simply relax and watch. This is a real company with a real product with real patents and with real FDA OTC clearance for the first time ever in the USA in this technology domain. The FDA created this domain space OTC because of Biel.<<<

POST of the day!! Especially the part about “we should simply relax and watch”.

All this other talk and disagreement is just rhetoric. We the stockholders just received something that was long sought and there is NO WAY this can be twisted and turned, ignored or argued about —- IT IS A VERY POSITIVE EVENT. One that in no way can be construed as NOT positive. Argue all you want about share structure etc. Do you not realize what has just happened! A small stinky pinky got the notice of the all powerful FDA and the all powerful FDA just confirmed that 2 of their products, after EXTENSIVE SCRUTINY, IS beneficial, safe and efficient in pain management for specific parts of the body. With this determination it is obvious that other uses and future products of this company will follow (back patch next?). Breaking through and convincing the FDA on the first product is ALWAYS the most difficult, as we have witnessed with this LONG process leading up to this approval. Can anyone really believe that the back patch will not be OK’d? That many more future products from this company for various other ailments will not be forthcoming? All of this will result in continual spikes in stock price, further strengthening the perception and validity of this company and its products.

So argue share count all you want or about whatever floats your boat, cause all I know is we have just surpassed the biggest hurdle and received the most sought after goal —- FDA OK! …”

now

Source: http://www.otcmarkets.com/financialReportViewer?symbol=BIEL&id=142899

Above is the graphic representing the sales, gross profits, and cost of goods by quarter since 2011 for the Bioelectronic Corporation (BIEL).

The 2nd Quarter numbers, just released today, were great. Record sales and they have started to consistently keep their cost of goods down. On the face of that stat, I have to think their manufacturing team is doing a very good job, although that is just the Cliff Notes interpretation.

To me the big thing is they are not losing momentum with Sales. They made a breakout around June 2015, and since then have been producing as hoped. The Lower COGS, higher Sales, and higher Gross Profits points to them getting their business model under control.

BIEL needs to catch a favorable breeze in the form of the FDA, but this period could be viewed as a positive in that they are developing the means of production. Let’s see what happens. Some positive statements were made on the quarterly report with regards to FDA Clearance. It wouldn’t be businesslike to front, but these are the Pink Sheets.

On a personal level, I could go for a chicken curry roti and carrot juice from a place on Nostrand Avenue and Fulton Street in Brooklyn. I haven’t had that combo in a long time. Something about this long hot summer.

Making progress with my play. I wrote about 40 pages of metered verse in kind of an old fashioned style, and am calling it Moonlight on the Post-Apocalyptic Dinner Theater. More on that later. It’s really good, and I pretty much hate what I write.

THE COMPLETE ZOMBIE WORLD ORDER TRILOGY FREE

JUNE 4TH AND 6TH FREE ON AMAZON

 

ZOMBIE WORLD ORDER TRILOGY

My open letter to the new FDA Commissioner:

Dear Robert M. Califf, MD,

Congratulations on your new role as FDA Commissioner. I wish you every success in your endeavor to safeguard the populace against dangerous and ineffective drugs.

Having said this, let me point out that your predecessor, Dr. Margaret Hamburg, was (allegedly) not as rigorously ethical as might be hoped. Please see the excerpt below. I have underlined some pertinent lines.

Excerpt:

“… Hamburg also came under fire when she approved the highly addictive painkiller drug, Zogenix
In December 2012, an FDA advisory panel of experts voted 11 to 2 against approval of the painkiller, Zohydro ER. The panel cited concerns over that drug’s potential for overdose. Indeed, 28 law enforcement agencies and addiction experts had voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses and deaths. Zogenix, could be used by people addicted to other opioids, including oxycodone.

Fifteen anti-addiction groups wrote a letter of complaint to the Secretary of Health and Human Services. Despite the safety concerns by the medical and law enforcement community, and despite the expert panel’s overwhelming rejection of the drug, Dr. Hamburg approved it.

The lawsuit provides documentation showing that from 2011 to May 2015, Dr. Hamburg’s husband’s hedge fund, Renaissance Technologies, “not coincidentally, held stock in Alkermes, the manufacturer of Zohydro amounting to tens of millions of dollars. Does anyone not recognize corruption?

The conflict of interest doesn’t end there. Adding even more insult to injury, Alkermes also manufactures a drug to TREAT addiction. So, both Alkermes and Renaissance Tech were given the FDA green light to rake in profits from both the sale of a highly addictive drug, then cashing in on the sale of a treatment for that drug-induced addiction!!…”

http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/

My point in posting sending you this is in no way to exhibit Schadenfreude at the Doctor Hamburg’s downfall. I think it is tragic such a talented person could have such egregiously misplaced priorities. Still, it does beg the question—could Doctor Hamburg have been  purposely sabotaging the approval of a device which could curtail the use of drugs to treat addiction, and even lower the rates of addiction!! One shudders at the thought, but have we really unearthed the depths of what the completely avaricious and selfish personality type is capable of?

So, I submit this as food for thought. I admit you don’t know me from Adam and compared to someone such as yourself, I am a mere dabbler in science, though I do make a living at it, such as it is, and have a graduate degree in Biochemistry. However, I think this email, if viewed objectively, should at least be considered as grounds for examining 510(k) file number K152432, and hopefully facilitating the approval of this drug free pain relief technology to the masses.

This technology is available in 50+ countries OTC, but not the USA. The graphic pasted below depicts results from a study published in the Journal of Rheumatology using this technology-link: http://rheumatology.oxfordjournals.org/content/early/2015/12/23/rheumatology.kev426.long

I leave you with a final thought: Someday, it will be considered barbaric that we drugged the whole body to treat the pain of one particular part.

Be well, and God bless,

PJ Kelley.

Graph Builder

 

The Musical Icon Prince just passed away, possibly by an overdose. I was a fan. I had Diamonds and Pearls playing in my car’s cassette deck for about a year a while back. It is tough to classify his genre. He was pretty original.

In a not unrelated news update, the FDA appears to be showing signs of gearing up to (finally) approve/allow the Actipatch by Bioelectronics to be sold OTC (over the counter) in the USA. More on this later

This approval will ultimately be due to the never say die attitude of Andrew Whelan, the mastermind at the Bioelectronics corporation. He saved this technology by shifting the focus from the USA and its Big Pharmaceutical Company owned FDA to Europe. One advantage of Europe’s Socialized medicine (there are several disadvantages) is the drug companies have less influence on the regulatory process, since the governments there are footing the bill more so want to try to keep it cheap. Bioelectronic’s Actipatch, a chronic pain treatment which utilizes the induced magnetic field generated by pulsed electromagnetic waves to alleviate pain is certainly an effective, affordable, and easy to use system for pain management. Actipatch’s popularity in Europe has generated independent testing by prestigious institutions and increased sales of the product.

Meanwhile, the FDA in the USA has never allowed the Actipatch to be sold here. Americans, you see, take drugs for pain. This is the American Way, and it kills a lot of people each year. People notice when a famous person buys it. Prince is the FDA’s latest victim.

Prince supposedly was taking Percocets, a legal prescription painkiller. People develop a tolerance and have to start ramping up. The Actipatch could have prevented this. This is drug free treatment. There are no dangerous byproducts breaking down in your liver and kidneys.

I mentioned earlier I think the FDA is finally going to cave in to political, economic, and scientific pressure and approve the Actipatch for sale in the USA and now I will list why I think this. My evidence is somewhat circumstantial and this might be tedious if you aren’t interested in this sort of thing so bear with me Also, a true expert will doubtless be offended by my attempt at explanation. I am trying for “less is more” here. Also, if you are too exacting in your FDA terminology, relax Approval and Clearance for Marketing are distinct. I get it.

  • The Actipatch has three paths to approval
    1.  de nova-primarily for brand new technologies
    2. predicate device-basically the Patch can get grandfathered in by referencing something similar which was already approved This is tricky for the Patch because the the most similarly approved application was listed as diathermy for directed heat treatment. Basically, the predicate device got approved in 2002, but the FDA got the mechanism wrong The true mechanism is actually now called  DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT, basically So, the FDA was not letting the Patch get approved because it would not accept the original as a predicate different mechanism). The FDA recently updated the Biolectronic listing to show that they will be  accepting the original predicate for the new mechanism–DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT. This could be the FDA tipping its hand that it is lining up its ducks for imminent approval
      1. To sum, click here and look at ” Device Classification Name Look at Decision-substantially equivalent (SESE)
      2. Now, click on Statement. It references the 2002 as the predicate device!!!!!!!
      3. !!!!!!!!!!!
      4. Takeaway-this got updated DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT was not getting to use the 2002 approved device as the predicate It seems to obvious as a giveaway, but apparently the FDA is getting ready to move.
    3. There is a third route to approval, arduous and you wind up needing a prescription for the thing called the PMA route, the October OTC reclass by the FDA hopefully rules this out

So above is the first bit of circumstantial evidence I have to present Below is the second

Import Alert 89-08

This one is a bit more of a stretch, but it is a revision regulating import that popped up when I searched the FDA site with these key words- DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT

What I got out of reading this was devices are getting blocked if they lacked proper labeling. One of the previsions in the October reclass stated the devices might need additional labeling to be allowed to be sold in the USA Not banned,just need the correct labels sounds like pending clearance for marketing

Here is the buy-in: The FDA is in slightly uncharted waters here and wants to do this correctly So, they are getting what they can ready prior to the official announcement

None of these delays helped Prince of course

 

Notes:

BRAUN and the Oxford University study should materialize pretty soon as well, so Bioelectronics may have a huge month in May-2016