Archives for category: PainGear

Linking and pasting this comment from IHUB. It is at least informative.

A while back, when BIEL was in the trips, I  came to the conclusion the best way to play this stock was accumulate and live correctly. This will play out, and it definitely seems like the stars are aligned. Trump wants a win on the opioid crisis going in to the 2018 midterms, and the ActiPatch is inarguably a step in the right direction for the future of Pain Management.

BIEL has run the FDA gauntlet with this before.  I imagine they overkilled that application. I’m pleased at how methodically BIEL is jumping through the hoops required to send the stock into orbit. Anyway, Tazzer is a long time poster on IHUB, and his comment is below. Bear in mind that a lot of the pick and shovel worked for this has already been done, such as safety and packaging, as Dewmboom pointed out the other day. Sounds like the FDA basically has to review a study. In a previous post here, I mentioned Keith Nalepka wrote the p value was well under the statistical limit to prove efficacy. With modern statistical software, these studies are pretty easy to analyze if set up correctly, and the FDA gave guidance as to how they wanted it set up.

In other words, let’s pray the process goes smoothly. The FDA (I imagine) does what corporations do, type up documents, pass them around for signatures, etc. It is a bureaucracy, so I don’t expect a miracle, but given what I wrote above and Tazzer’s comment, why wouldn’t this happen fairly quickly?

Thanks to Tazzer, by the way, I enjoy his/her posts.

Comment by Tazzer on timeline for FDA approval

“I realistically estimate 510K approval in 11 to 27 days expedited and 57 calendar days based on the normal timeline guidance.

Time line for statistical comparisons. FDA considers the start of the process the day they received a letter requesting guidance on a 510K. Usually takes 30 days before FDA gives guidance for submittal. BIEL had their review May 9th. So we are currently 67 days in the process. The numbers I suggest are reasonable. I am saying best case is 78 days worst case is 124 calendar days. In 2016 19% of 510Ks reached approval within 90 days from the beginning. Ours is expedited so hopefully we will be before 90 days.

https://www.emergobyul.com/resources/research/fda-510k-review-times-research

Refer to link for FDA 510K time guidance. Although it could be sooner given its an amendment to an existing 510K. Plus they already looked at the back study. Tick Toc…

Price will head towards at least a penny in next 27 Calendar days. GLTA!

Normal FDA 510K is projected to be completed in 60 calendar days once FDA approves 510K submission. BIEL received their approval on July 12 2018.

Just based on the regular not expedited we have no more than 57 calendar days till approval worst case scenario.

Expedited I would estimate 11 to 27 calendar days to approval would be my guess. Already day 2 so getting closer to approval.

https://www.emergobyul.com/blog/2014/01/us-fda-provides-510k-communication-timeline

https://www.fda.gov/AboutFDA/Centers

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I’m saving a couple excellent comments for posterity and reference posted on the IHUB board. If you read this blog, I base my interest in this stock on primary research articles, and have analyzed them to the point of putting the data into my own statistical software (JMP). We actually got The Oxford Journal to issue a correction for one of their published charts based on my analysis of their data. For brass tacks, real time analysis of BIEL related FDA matters, IHUB is a good source. People reach out to the company, as seen below.

I’m pretty stoked about the new 510K submission for Expanded Clearance. I have a very vivid vision of going to Sam’s Club and buying one of those big First Aid kits and finding a couple of ActiPatches in it. I’m not too visionary, but sometimes a little ahead of the curve. People are going to go through the hoops some of have jumped through and start seeing the potential of this treatment.

If the Bayer/Dr. Scholl’s deal comes though, then you have that and the Expanded Clearance Application (world’s first electronic aspirin) in the mix. Explosive.

I post the comments below because I agree with them based on my research. This is complicated stuff

 

Courtesy of Markjohn

“Here is a reply about the word “trsitional” (sic) in the press release-

From Sree Koneru

Thank you for your message. The 510(k) that was filed does combine indications from the previous 510(k), which is why we are asking for “expanded” indications. The word “traditional” in the 510(k) is just to indicate the type of application prepared, as there are only three types. Seeking expanded indications automatically requires a “traditional” 510(k), since the other two types are for device modifications etc.”

Courtesy of Dewmboom.

“I am glad you looked at this and I did not want to confuse people with too much information here. I have looked at this very carefully well before now and here what I found.

If you look at the definitions of all 510Ks as well as the EAP. The circumstances of the Actipatch does not fit any of the definitions.

For the traditional 510K, Biel already waited months to get the FDA approval for knee and foot. So, they paid their dues their. As for the specifics of the abbreviated and special 510K, they do not fit the exact definition for why Biel is submitting when you look at them. The EAP does not apply because the Actipatch is not a life threatening breakthrough technology.

The only thing we know is that Biel has a pre-meeting with the FDA, and during that meeting the FDA gave them guidance on how to submit for expedited processing knowing the circumstances, evidenced by this quote:

Quote:


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.


As I indicated before, the FDA drilled this to the nth degree already and there is no good reason for it to take any longer than 30 days. Biel is not making any changes to the device, they are just showing a clinical trial for back pain to expand the approval into full body muscle and pain.

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/ ”

speakerhim

“My only guess as to why a traditional path was taken(if it was at all) is that the general actipatch for pain could have been guided to a traditional route to secure a solid foundation for all other applications for expedited clearance, including recoveryrx, allay, maxofacial, etc… ”

 

All interesting comments. We are dealing with a completely new portable approach to Pain Management. There is going to be some confusion every step of the way, but the important thing is the gamechanger got filed, and filed by a group with a proven history of success (3 FDA approvals, NHS in the UK, and the BRAUN deal.

20160713_14282320160713_142828

 

 

Link here:

 

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

 

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.