Archives for category: LYME DISEASE AWARENESS

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

 

 

BIEL Files. Thanks to toomuchwasabi for posting this. This is the big one.

FREDERICK, MD, July 12, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that a Traditional 510(k) Premarket Notification for ActiPatch® was filed today with the U.S. Food and Drug Administration (FDA). The market clearance requested was “over-the-counter adjunctive use in the treatment of musculoskeletal pain”.

….”The 510(k) was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who spearheaded the 510(k) effort, said, “We are confident with the strength of our data and overall application. Given the FDA’s prior knowledge of the data and prior clearances, we believe that the 510(k) will be processed in a timely manner.”….”

https://globenewswire.com/news-release/2018/07/12/1536528/0/en/BioElectronics-Files-FDA-Application-for-Treatment-of-Musculoskeletal-Pain.html

 

Flow Chart of The New 510(k) Paradigm

 

 

This blog is about what interests me. What interest me falls into a general pattern.

Lets read the tea leaves for Bioelectronics. I’m doing this for the non-obsessives. I’ve learned that some things I take for granted logically do not always follow naturally for others. So this is for people interested in BIEL.

  1. The last time Keith Nalepka was on the radio, he said he would be back within forty days with news, basically about the Dr. Scholls deal getting finalized.
  2. Premise-the Dr. Scholls deal can’t get finalized until General Clearance for Pain is granted by the FDA, along with with the wound healing application. This will make the deal better, and will be what the ad campaign is based on. So Bayer/Dr. Scholls needs this before this goes live.
  3. Two days ago, Keith Nalepka said he would be on the radio within the next three weeks.
  4. Sum= Keith Nalepka expects to get General Clearance within the next three weeks, and to be on the radio discussing the Dr. Scholls deal, finalized.
  5. So, General Clearance within the next three weeks?

Steps 1-5 make sense to me. If Nalepka committed to the radio talk, read between the lines.

A general comment—I expect wound care to be easier than general muscle pain, data wise. People are wooses. I don’t expect an honest answer about pain from most people. It’s tough to gauge. Given enough cases in a well run study, yes, you can generate valid data, but I innately am suspicious of gripers.

Wound care, however, is a beautiful study. Just take a thousand similar wounds, treat 500 with an ActiPatch and 500 with a placebo, monitor objective criteria like healing time, swelling dissipation, scar formation, rate of infection, there are multitudes of data you can can chart, graph, correlate. Now you’re talking my language. How do you feel doesn’t work for me, especially when half the people in the study might just be whiny crybabies who want an opioid prescription.

Why do you think the German giant medical stock BRAUN like BIEL for it’s wound treatment in that recent major deal? Because you can prove wound healing with data with no debate really.

Anyway, it will be interesting to see how it plays out. I have to thank Keith Nalepka for his transparency on Twitter. Follow him, let’s make him a Blue Check.  Expect a press release next week as yet another European country announced it will pay for the Actipatch. Sweden, which has one of the greatest health care programs in the world, joined the UK in adding Actipatch to their national health care program. I thought Germany would be next in line because of BRAUN, but I will take Sweden, a world leader. It is exciting to see all this finally playing out.  I’m rooting for Andrew Whelan and the team. It’s like the Old Man and The Sea, as  I have said before. He caught the biggest fish in the world, and for all the BIEL shareholder’s sakes I hope he can bring it home. Something tells me the sharks already had their best chance.

 

 

 

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!!

 

Okay, so my post about BIEL on Twitter sort of got upstaged here. This got picked up by Yahoo pretty quick. I will do the math for you–7x 160,000=1,120,000 units a years just got sold. I had to ask the Gifted kid to do the math for me, because I can’t do math when I get giddy.

Also, FDA, put this in your pipe and smoke it. Next step is Germany announces it will reimburse for the ActiPatch the way the United Kingdom has through its NHS. The FDA better get it in gear. Margaret Hamburg, the Renaissance Hedge Fund, Hillary’s grifting out FDA top slots to her political stooges—those days are over. Trump doesn’t know enough about how government really works to know how much money he is leaving on the table by not taking the opioid payoff money. Hillary never would have let this happen.

#BRAUN!!!!

 

https://finance.yahoo.com/news/b-braun-medical-includes-bioelectronics-120000701.html

 

B. Braun Medical Includes BioElectronics ActiPatch Medical Device In Its Same Day Knee and Hip Surgical Program

GlobeNewswire

FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK Group to improve care and reduce the UK healthcare cost of its 160,000 annual hip and knee replacement procedures.

The “fast-track” same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a specialized wireless tablet. Each patient will be given an ActiPatch medical device and a prescription for 6 additional ActiPatch devices. A similar program is being implemented for spinal surgeries.

Phil Cleary, Senior Product Group Manager, stated that “our TOTAL Pathway program http://media.cdn.edgecdn.net/zvts/1486044207/videos/videodb/2512/videodb_2512_31266_9406897_16x9.mp enhances our commitment to patient safety, post-operative care, as well as significantly reducing healthcare costs and hospital stays.” Treating post-surgical pain requires a multifaceted approach. In trials, ActiPatch was well received and produced positive outcomes. We look forward to making this program a success, in the UK and other countries where B. Braun operates.

About BioElectronics Corporation

BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.

About B. Braun Medical Ltd B. Braun Medical Ltd, UK, https://www.bbraun.co.uk/ is a member of the B. Braun Group, https://www.bbraun.com/en.html one of the world´s leading healthcare companies. On an international level, B. Braun’s 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services.