Archives for category: PainGear

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My  thought is why BIEL should have to wait until November for FDA General Clearance so the FDA can take credit for “developing” them. The FDA ground an spiked jackboot into the faces of this company, its investors, and this technology. Now they want to stall us so they can take political credit? This is bullshit. General Clearance could take place on Monday, and should. This stalling tactic by the FDA is a sign of desperation and panic by those pillpushers as one of their pharmaceutical pimp masters prepares to unleash a new drug treatment for migraines.

BIEL has disruptive technology. So what? It is better for people. The FDA needs to get their house in order and perform their stated (supposed) primary function: ” Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation….FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health…”

The FDA does not need to “mold” BIEL. BIEL educated them, literally, into two clearances and now needs the third one (Back) to get the General Clearance, the world’s first electronic aspirin.

The Democrats are out of power, and Trump is going to run a clean game so he wins a second term, then we’ll see.  In other words, there is a new sheriff, and he will be around until 2024 unless some piece of shit establishment thug gang assassinates him they way they murdered the Kennedy brothers. Deal with it. BIEL only needs you to do your jobs, now, not some bullshit program designed to hide the fact that the FDA murdered millions with opioids.

Updated 6-4-18

I figured I may as well just ask somebody at Bioelectronics about this issue, and thanks to Keith Nalepka for a prompt reply on Twitter. I have a deep distrust of the FDA process, having been a longtime shareholder. My next question would be if the FDA gives General Clearance now, what exactly will they do for BIEL in November? The free market will fuel further research and development once the FDA does its job and provides General Clearance. This FDA program sounds great, and would have been an especially amazing idea ten years ago. It’s as if the opioid crisis started on the day Trump was inaugurated.  The whole thing smacks of political opportunism, a quest by the FDA to stay relevant as they got outdone by other regulatory agencies around the world. BIEL did this without the FDA’s help, indeed, with the FDA’s active resistance. I put the pieces of that puzzle together a long time ago, on this blog (see Margaret Hamburg and the Renaissance Hedge Fund). Not a pretty picture. All BIEL needs from the FDA is General Clearance for Pain and then timely review of other applications, such as Migraine.

Note–I have nothing to do with this company except I bought some shares. If somebody from the FDA reads this and decides to get revenge, all they will really be punishing are sufferers from pain. I don’t matter. I am simply not the forgiving type. A lot of people could have been helped if the FDA had been an honest agency in the Obama era instead of a slush fund for Hillary’s political cronies.

Anyway, thanks again for the reply, it made sense.

Screenshot 2018-06-04 at 7.47.19 AM - Edited.png

 

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I learned a new word yesterday, or at least realized my previous definition was subpar: “astroturfing”. Sharyl Attkisson gave a talk about it.

Ms. Attkisson is the reason I usually say 99% of all media are corrupt liars. She is a one percenter.  There are a few I like.  She is famous for exposing the dark side of the 2008 bank bailouts (was there a light side?), and also for exposing Hillary Clinton’s “sniper on the tarmac in Bosnia” lie.  More relevant to today, she is also famous for accusing Obama of hacking her computer and cellphone. This does indicate a behavioral pattern, if you follow the story about Trump’s campaign getting infiltrated Watergate style by Obama’s crew.

Please watch the video below. I call such videos “Anti-Idiocracy” moments. Briefly, “Grassroot” movements are genuinely organic social movements that spring up from actual human beings spontaneously, reminiscent of mass migrations of the serfs Tolstoy wrote about. Astroturfing is when a fake stage is set for a fake movement.

Attkisson is mainly speaking about the pharmaceutical industry, but it does not require much imagination to apply her principle to anything, any product, politician, or political push.

Note: I am a long term proponent of a product and company, ActiPatch and the Bioelectronics Corporation. I am an investor, and my blog deals with this quite a bit especially lately. I must ask myself, am I grassroots or astroturf? It is legitimate as a question. My answer is my book, Zombie World Order, in which I deal extensively with my views on the corruption and dangers of the opioid industry. 8 positive reviews and one asshole from Twitter who didn’t read the book. Buy it, it will change your life and mine as well, because then I will be a fourdollaraire. Yippee!!

 

First off, congratulations to the IHUB BIEL board, which is approaching 1000 followers. I admire many of the people who post there, although I am not a member myself. I am leery of the negative emotions the social media circus triggers, and since I would most likely be banned in about 5 minutes, it’s pointless.

I do thank the long time posters there, many of whom I have linked to on this blog so readers here could benefit.

However, let’s face a sobering truth, nobody really knows about the ActiPatch. It has never “gone viral”. We’ve had a couple of nibbles, and a lot of people who were desperate and seeking pain relief stumbled on to it, and that is a big part of why Bioelectonics (BIEL) is still a story. The ActiPatch works.

Also, nobody really knows about this company. Everyone is in the market, but this is usually through a 401K plan. Nobody buys subpennies. Your broker will laugh at you. He is paid to laugh at you. It’s a total sheeple mentality. If you can remember 2008, when all the “smart money” stocks got obliterated due to widespread economic fraud, you may take “smart money” with a grain of salt. We need to get more shareholders for this value based stock with a great pipeline and concept.

So, we have a relatively unknown product and a relatively unknown stock, after years of noble effort on IHUB by some of the best, smartest, and most creative people on the Internet.

Where am I going?

Fidget Spinners.

Yes, you read that right. I had never heard of a Fidget Spinner in my life until Baron Trump (what a name) got off the Presidential helicopter playing with a fidget spinner. Suddenly they were everywhere, gas stations had them, quickie marts, etc.

Twitter did that. Baron went viral on Twitter and other social media and fidget spinners became a thing.

So, get on Twiter and follow Bioelectronic VP of Sales Keith Nalepka. He gets it. Follow all the Bioelectronic people, and retweet their news announcements. You will find this rewarding–these are very smart people. Also, there are multitudes of people sincerely trying to get relief from pain safely.

I don’t know how many people are on Twitter. A hundred million? For the loyal IHUBers–the best day of our investment lives is when we finally lose any control over this stock and technology. There have been days when I have had a good percentage of the stock’s volume–how is that even possible? So, lets get behind Nalepka’s effort and start pushing this on Twitter.

Keith Nalepka Retweeted HHS.gov

we have been innovating, look paid for by the NHS in the UK, proven in trials to lower medication use, fewer doctor visits, sold in 29 countries, its time for the US market to see the light, large retailers are taking notice, oh and its OTC.

Keith Nalepka added,

Not a great day. Weak sales translated into an opportunity for people to short the stock to the tune of a 25% drop.

Not pleasant, but wasn’t this whole run up fueled by a  short squeeze on traders who were caught by surprise when the NHS announced subsidized payments on the ActiPatch? These guys make the market.

The expression “keep your eye on the prize”. Where you want to be on the day the FDA announces General Clearance is  sitting on a couple million shares of BIEL. The first two FDA clearances were not long after a successful FDA meeting. This is where the new lawyers for BIEL explained to the FDA why the ActiPatch should be OTC.

As per Andrew Whelan, once BIEL gets that third clearance (Back) this will translate into a General Clearance. General Clearance is your money melon, and the main reason I am troubling myself to hold on to this stock.

Let’s see what BIEL has to say after the May 29th FDA meeting. 8 trading days left till it, then maybe 2 to develop a press release.

After this stock hits, the next stop is physical silver. I mean to stay poor, even after I get rich.  Poverty is your treasure, don’t lose it, as the Buddhist koan goes. Silver is a ticking time bomb.  The Implosion in 2008 was partially fueled by the wheels coming off the silver rig. Buying mining stocks is pointless. Just get physical.  Plus, BIEL has taught me something–I hate the stock market. I aim to get rid of that third party risk.

Since JP Morgan will be rigging silver for the foreseeable future, I can wait for BIEL to outwait the FDA, who must eventually run out of excuses. I think TENS has more at stake in stopping BIEL then the dreaded Opioid cartel at this point.

Winding up May 15th, 2018.  Bioelectronics will most likely release a statement about the May 29th FDA meeting by June 1st, 2018.  While BIEL cannot comment on the General Clearance meeting which took place on May 9th (or so) while in process, it might well provide some hints included in the May 29th release on the separate FDA application for wound healing. This would be the tactful way.

Waiting for  the “ink to dry” on the Doctor Scholl’s agreement. I have a pen here at home I could have lent them, usually  dries completely in about thirty seconds. I admit it is not a very special pen, I think I lifted it from a bank, but I would have been happy to donate it, for future reference.

A fairly ideal outcome for this press release-These applications are very template driven, the hard part was the creative effort to invent this and get through all the other hurdles.

IHUB is going to get ugly near term until the recent spate of orchestrated stock shorters throw in the towel. Last FDA approvals, it took several days for the stock to really spike. I think this news needs to sink in, be understood and digested by the investing world.

No new testing required and the previous 510K submission can be used. Approval for the back means full OTC General Clearance. Migraine, Menstrual, Carpal Tunnel, everything can go easier, not to mention post surgery coming up on May 29th.

 

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application

GlobeNewswire

FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). 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. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints.

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. Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.

An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.

About BioElectronics Corporation

May 9th has a few saints of special interest I found, as I was perusing Butler’s LIVES OF THE SAINTS this morning.

Saint Pachomius, one of the founders of monastic life in Christianity,  was plagiarized by Karl Marx and never given attribution. Saint Pachomius’s version was based on communal living through the teachings of Christ. Supposedly, he had these teachings from an angel, who gave him a brass tablet with instructions on it.  Shades of Mormonism there. Some say Saint Pachomius, who died in A.D. 348, spent some time in pagan temple before his conversion and got some organizational ideas from that. He had 24 character types using the 24 letters, and assigned a type to each individual monk.

Marx ripped the guts out of Saint Pachomius’s teachings, and replaced Jesus with a kinder, gentler, machine gun hand (thanks Neil Young!).

Saint Gregory Nazianzen, the reluctant bishop of Constantinople, has a message for this day, I think. Quote:

“He (God) gives with greater joy than the joy with which we receive. Only let us not be too apathetic in our petitions, or set too narrow bounds to our requests.: nor let us ask for frivolous things, which it would be unworthy of God’s greatness to propose that He should grant us.”

When persecuted by the Arian Heretics and Apollinarists , Saint Gregory reflected that although his adversaries were the stronger party, he had the better cause.; though they  had the churches, God was with him; if they had the populace on their side, the angels were on his.

Great old used books are haunted creatures. One opens up a page at seeming random and discovers an insight, but it makes sense the book opens to a natural bookmark created by someone else who read the same passage frequently.

Today is an historic occasion, not frivolous at all. Bioelectronics Corporation is meeting with the FDA to try to get full clearance for the world’s first electroceutical aspirin, an approval long denied by the bundlers for Hillary Clinton installed as the heads of the FDA by the previous administration. Margaret Hamburg, who has been dealt with in this blog before, pushed the opioid agenda so she and her hedge fund owner husband could rake in hundreds of millions of dollars. Hillary was bribed, and pain sufferers died.

All supporters of Bioelectronics are asking for is fair play so a safe, effective device can be legally marketed in the USA, as it can be in most of the civilized world. This company and this technology are on the side of the angels. What side is the FDA on? I guess we will find out this month. History comes in waves, and if I was the FDA I would remember ultimately their best job security is to do their jobs, not the job of the opioid cartel.