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fuente - your message has stimulated an interesting thought.
Call me naive, I am not expert at these things, but I was taught that there are very few stupid thoughts and fewer stupid questions that involve a provocative idea.
Drugs cure diseases, kill bacteria, devices do not - I believe you are correct. However I don't recall BIEL claiming its devices cure diseases. My understanding is that the company claims its devices reduce pain and promote healing, which is exactly what happened to me with a very badly sprained ankle. I had no disease, no infection; I sustained an injury (tennis) which required natural body tissue healing, not a cure.
In the case of ALLAY, does the company not promote its device as reducing pain, cramping and so on? Again, not a disease requiring a cure? However, the ripple effects of ALLAY seem to be huge - family, work, leisure, sleep, etc.
In the case of painkiller tablets, capsules, caplets, etc., etc., is it also not rue that they do not cure a thing, that they only mask pain? A good thing, but involving ingested chemicals.
So, the question that arose when I read your post is this. If BIEL's devices treat pain and therefor promote natural body tissue healing as alleged, just like chemical painkillers, might the BIEL devices potentially be overwhelming 'new' developments in total marketing and sales opposition of the chemical painkiller manufacturers and marketers? Might it also be logical to think that the FDA decision makers fully realize this potential and may simply wish/need to 'get it right' so the administration remains above reproach because of the potential impact? This seems to me to be a reasonable approach, given that BIEL already has FDA approval for its post-op eye device. As I said before, if I am J&J, I am looking at Biel as a potential acquisition target to get my hands on the strong IP protection of its patents.
Love your cut-to-the-chase logic 3 pointer.
People invest in public companies to buy a ticket on a ride into the future, not the past. Very bright scientists developed PEMF and I guess someone else then developed the BIEL patented product for post-op eye surgery treatment, the FDA approved it and BIEL owns that. Period! The company has applied for numerous other approvals for the same treatment on an OTC marketing and sales basis on new, patented products, for several indications using that same concept which has proven to have no harmful side-effects.
To your comment about politics and corruption, call me naiive or too trusting, but I cannot imaging anyone at FDA or an elected official being stupid enough to risk the mess in the press, a public trial and jail with the key thrown away to reject BIEL and its already approved product for another indication. Makes no sense. The public, the courts, the SEC, Wall Street, the banks, all got wake-up calls, what with Marta, Enron, Bernie, the Crash, etc., etc. Nope, I like the FDA, and what it does and how it does it. It protects us from idiots who would put melamine in baby formula and sell it for profit.
Using my perhaps simple and naiive logic is the precise thought process I went through before buying shares in BIEL. If the shares had been trading at a dollar or more, I would still have bought. I know, a hundred posters are going to say they will sell me their shares at a dollar, but you get what I mean.
On balance, I find no reason why the FDA would not approve BIEL's applications. So much so that if I were the Chairman of J&J, makers of Tylenol, or other companies making painkillers, I would buy BIEL, so I would own the patents on a breakthrough pain reliever, therby gaining an advantage over my competitors. Can you imagine - approved devices to replace chemical painkillers? The concept is mind boggling. But, for the moment, I own a piece of those patents held by BIEL - that's why I invested.
Great question Brabo - one I had not even thought of asking, as I have been focused on future events rather than past ones. I have no idea what the correct answer may be and we'll probably never know. Money, technical development, research, vision, horsepower? They all come to mind. But my reality is as I've stated. PEMF is now approved and specifically for post-op eye surgery patients, prescribed by surgeons to hasten healing.
I didn't know it was 10 years ago, but does that elapsed time not give even greater credibility to PEMF and BIEl, inasmuch as the FDA did not do an about face in say 2006 on its previous BIEL approval? Was the previous approval for a company other than BIEL? Did BIEL buy that idea and approval and product and form a new compnany? 10 years is a long time and I don't know how long the current org and management have been in the driver's seat.
But whatever, the company is where it is now, with its new applications before an august body - the FDA - charged with the responsibility of protecting us and the treatment for the indications they have been asked to approve. On a product already approved by the same FDA that approved the eye surgery treatment 10 years ago. As I said in last post, next?
Next for me was to look up BioElectronics and to my suprise found it was a small public company trading at a ridiculously low price, so I bought some shares. My current next is what happens when BIEL's latest applications are approved? Wish I could afford to buy a ton more.
Hi Super - Think your reference to throwing in world peace making the list of approvals a little on the side of dismissive of the previous poster. What I mean is that the product approval list seemed to follow well on the heels of the question as to if the FDA is considering a multi-product approval concept.
I am not suggesting they may or may not be, but I liked both the question and the approval list.
As a user of ActiPatch for a very badly sprained ankle, I know it worked almost miraculously. Days to walking pain free versus my doc suggesting a few weeks and lending me some crutches which I returned in 2 or 3 days. I left it on and it obliterated the pain.
Secondly, I know the FDA has already approved BIEL's PEMF device for post-op eye surgery treatment - around the eye and close to the brain, making the noise about comparing PEMF to cell phones and other devices absurd - so PEMF and specifically BIEL's device are already approved. Nice.....
The other indications applied for are potentially incredible if approved. Sales of ActiPatch and ALLAY are potentially huge in the USA - can you imaging how many women suffer from pains and cramps from monthly cycles and pop pills for a week or so every month for it, thus treating the other spousal and familial issues for them and all around them? Can you imagine - no more chemical painkillers, every month of every year?
I see no reason whatsover why BIEL will not receive approval. PEMF is already out of the box. I cannot imagine a doctor prescribing the BIEL device for an eye surgey patient going through a process of questioning his patient, "do you currently, or have you ever had a sensitivity to PEMF?" Nonsense - PEMF and BIEL are approved for prescription by doctors for post-op eye surgery patients. I bought it from a friend in Canada, I used ActiPatch, I could not believe how well it worked. Next?
OOPS - Plantar Fasciitus :)
I was wondering if the FDA was assisted in doing its proper job by FDA oversight, competitors of BIEL or by others. Folks could laugh at me and say, "Are you kidding, BIEL will never be a competitor of Johnson &Johnson, manufacturers of the Tylenol line of products. J&J clearly have their own issues from the old news I found from a year ago or so.
I have used ActiPatch on a badly sprained tennis ankle and have no need for any other product for sprains, strains PlanterFac ligament issues etc. That makes BIEL a winning competitor over J&J and when the FDA approves other BIEL products in addition to the post-surgery eye device already FDA approved this company will be on very solid ground.
J&J's contamination of product from a chemical reaction from the pallets used to store product resulted in a recall? Product testing found the problem and protected consumers, all good. If I am J&J and I see BIEL is not following FDA protocols? It's normal for someone to make the call. Now that BIEL is apparently in compliance, it is old news, I think. Great work by the poster who found the warning letter within a few days. I found the link below in the public domaine by searching - Tylenol manufacturer, so it is proof the rules are the to protect us all and sometimes they work. But can you imagine not having to take pills for a wide range of aches and pains? They only mask the pain, while I believe ActiPatch got to the core healing issue of the sprain, and helped the damaged tissue recover faster than normal recovery times. First-hand ActiPatch worked amazingly well by obliterating the pain while I was healing in days instead of weeks on crutches.
http://www.lakecharleslapersonalinjury.com/2011/03/additional-products-liability-issues-for-tylenol-manufacturer.shtml
On behalf of Veron, Bice, Palermo & Wilson, LLC posted in Product Liability
HEADLINE
Additional products liability issues for Tylenol manufacturer
31 March 2011
A couple of weeks ago we talked about how the company Johnson & Johnson faced product liability issues over the recall and production of Tylenol. The company failed to follow federal manufacturing guidelines in three of its factories that produce Tylenol and as a result the government took over the facilities to avoid further product safety issues. But, it appears the product liability issues for Johnson & Johnson and Tylenol are not over.
The company has recalled another lot of Tylenol voluntarily because of consumer complaints about a strange, musty odor. The company has recalled one lot of Tylenol 8 Hour Extended Release Caplets. One lot is around 34,000, 150 count bottles. Johnson & Johnson believes the strange odor was caused by small amounts of chemicals called 2, 4, 6-trichloroanisole (TCA) and 2, 4, 6-tribromoanisole (TBA). The decomposition of a chemical in wood pallets used to transport and store the packaging materials for the company's products creates TBA.
Consumers who have used the contaminated pain-relievers have experienced stomach issues though the medical issues are not serious according to one doctor reporting on the incident. The doctor said, "They're not that severe -- we're talking about vomiting, diarrhea."
The affected medicine was produced at the McNeil Consumer Healthcare plant in Fort Washington, PA before the production site was voluntarily closed in April 2010. The company recalled 128,000 bottles of the same product in October 2010, and in July 2010 the company recalled 21 different products including Motrin, Benadryl and Children's Tylenol. In April 2010, the company conducted the largest recall of children's medicine recalling 130 million bottles involving over 40 products.
Source: ABC News, "Johnson & Johnson recalls yet more Tylenol," Katie Moisse and Kim Carollo, 3/30/11
Seems to me the FDA Warning Letter is following established protocol in regulating applicants in not jumping the gun - therefor they are protecting the public. The old philosophy 'it is sometimes better to beg for forgiveness than to ask for permission' will not work in an FDA situation - BIEL must comply with the regulators.
However, I'm miffed that the FDA can regulate actipatch.ca, since that is a Canadian regulated URL. Would it not work for the company to simply put an accurate and honest statement in large font on all websites that it is not currently permitted to market or sell any products not approved by the FDA in the USA but that applications to the FDA for approval have been made? Maybe they are not permitted to do that, but makes no sense to me.
I could not buy actipatch in the US and had a buddy in Toronto who had used it a few times courier me 3 after I badlly sprained my ankle playing tennis. It worked amazingly well, couldn't believe it. Days to complete recovery instead of weeks and weeks. My doctor was amazed and said he could not prescribe it, so I didn't do anything wrong, I asked my buddy to send them to me because I remembered him telling me about them. He used them for sprains and for tennis elbow, then put a strap on his elbow and hasn't hasd a problem since. That was over two years ago and he plays 4 times a week. The FDA knows all this since they have all the trial results.
As far as I'm concerned, the FDA reiterates its approval for post eye surgery use - perfect - the rest is therefor a no-brainer, however the company must wait for approval. Seems clear the FDA was only doing its job to write the warning letter-they are not stupid and would never risk writing such a letter if the company was in full compliance. The FDA is there to protect us, but the cat's out of the bag with the eye device. So, the company must respect the process. So get compliant people and don't mess with City Hall. The FDA probably writes thousands of warning letters-it should. But the great thing is the BIEL approval for doctor prescribed post eye surgery use is a reality - hmmmmm, okay to put on my eye after surgery, but we don't think it is good for a sprained ankle? Please....
So, assuming BIEL is going to get and stay compliant, when is ActiPatch going to be approved for all the less sensitive parts of the body, than the eyes?
Thanks very much for the message and link Kid. I checked out the correspondence from the FDA on the first device, the infrascanner, and it is interesting to note in the Decision Summary link in the right column that the applicant was turned down in March of 2010 when FDA issued its rejection letter. The applicant then re-applied, presumably fairly quickly, for Class II de Nova classification after that March 2010 rejection and was approved in December 2011, some 20 months later, from the rejection date. How does that stack up with BIEL's status although the two are completely unrelated? I still believe the logic found in BIEL having already been approved for the post eye surgery Recovery Rx and that the process the company is in now is just a procedural one. Thanks
Apparently can't Rx or buy them here yet. I had to get a buddy to send 3 down to me in NY from Toronto by Fedex. He had bought them on-line for tennis sprains. My doctor had heard of them but couldn't source them here. I showed it to him and after 3 days of constant use on my ankle he was blown away, swelling almost completely gone and I was mobile without pain. Gave him back the crutches he had loaned me.
I bought BIEL shares after using ActiPatch for a badly sprained ankle - incredible results - cut weeks off healing - can you imagine not having to take painkillers every four hours and feeling like crap as a result? Great product. If they got FDA approval for post eye surgery, why not the rest? Just logical.
Can't imagine what is going on?
Posts deleted from 19398 to 19421 = 16
I can understand the senseless over and over negative or positives being deleted, but the questioning, answering and informative? I would think the incessantly negative ddls posts and deletions do nothing more than frustrate everyone and destroy the integrity of the website?
Thanks very much Fuente - very helpful
Thanks IRB - just need the reasonable facts and status without the critical rhetoric of he said this and she said that - this is business and I can see a lot of good and patient people have invested their funds and therefor have assisted BIEL in getting this far - I just need to know where we are without doing a post-graduate degree in who said what to whom..... :)
Hi Disciple - Didn't they file answers or backup to FDA questions last summer or fall as supplementary information? I seem to recall reading about it in a company or media site PR somewhere??
Also, on company folks selling shares in the tens of millions, maybe a few hundred million, as complained about here, shouldn't we be focusing on the fact that investors are buying that stock? I'm no expert on the alleged manipulations, but I bought BIEL shares because I have first-hand experience that Actipatch worked on a badly sprained ankle and amazingly without painkillers.
The only other questions that come to mind on the FDA applications are; (1)is it a question of fees to the FDA remaining unpaid?, (2) was someone at BIEL abrasive with someone at the FDA?, and (3) is the absence of a ruling necessarily negative? If the answers to these last 3 are all a no, then aren't we okay and we just need to be patient? Thanks to you or anyone else for helping me understand.
madp - you were extremely insulting and demaning of BIEL in general, company management and, by implication, all other investors on this MB. Predictably, you shallowly objected to being called on those posts with more over-reactionary insults toward me when administered some of your own medicine.....
I can just imagine your wah-wah wailing and blaming-of-others flanking if and when BIEL gets its FDA approval.
I thought sites like this were business sites for the exchange of positive, or negative, opinions and ideas by mature people from all walks of life, all levels of education, formal, or informal through experience, all equal and without fear of being insulted by your posts - go back and read your last few posts and find one constructive thing, if you can.
Back to BIEL - great products - personal experience - amazing results - management put it together and took it public. Why? To screw investors out of a few million dollars? No way. Management is working toward FDA approval of a viable alternative to drugs that worked like magic on a badly sprained ankle. That's why I invested. If they are successful, there should be a big financial score here. Go BIEL - get that approval boys! Home Run!!!
250 million shares raised them less that a million dollars? So what? Wahhhhhh.
As I said a while ago, if management has to raise money to keep the lights on, meet payroll and pay for regulatory expenses, I wish them well. Keep doing it boys.
Meanwhile, stop whining madp - you said you "flanked at college"? - so, now that you are an FDA process expert since your experience attending classes, soaking up the knowledge and flanking at college, you should buy more BIEL, because if and when they get their FDA approval and you don't own a ton of shares your whining will be a cacophony of wah-wahs, boo-hoos, sobbity-sobbity, PLOM syndrome and that old favorite hit parade song; Cry Me A River by Boo Hoo Flanked. Curious - what college did you flank? Strongly suggest you buy a few million shares so you are not outflanked.......you may then be eating filet mignon instead of flank steak......
Also - asked a while ago if GBull or anyone else has ideas as to what the pps might be on FDA approval?
Hey GBull - At the helpful suggestion by UK Sausage to do a little more research, I found the mission of the FDA. It is clear the goals are safety, efficacy and security of humans and us mutts. Nice mention of medical devices, FDA likes them too and it clearly acknowledges their endorsement of alternatives to drugs, it's where the world is and should be going.
QUOTE
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. UNQUOTE
So, both the FDA and Health Canada have safety and efficacy as the priorities - as they properly should. And they both cite devices.
To your post - I invested in BIEL because the ActiPatch worked a small miracle on a black & blue sprained ankle and I did not have to take the painkillers and anti-inlammatory drugs prescribed by my Doc. After 3 days of almost 24 hour ActiPatch, I went back to him, walking comfortably, most swelling gone. Tender? yes. Tentative? yes. But I was mobile and pretty comfortable. He couldn't believe it. It works!
Why did I go back to my Doc? To return the crutches - comments he made to me after the examination were were - "X-ray shows no break; you've got a very severe sprain, which is often more painful than a cracked or broken ankle; you'd better be prepared to be mostly off that ankle for 3 weeks to a month and here use these."
In my opinion, if BIEL does not get FDA approval ASAP, it is proof that the drug companies can influence decisions inappropriately, but I stress, I'm not a scientist. When BIEL does get its approval, it will be solid proof that the FDA is above the influences of the big drug companies and common sense prevailed. Pretty simple stuff.
I bought $25K worth 10 days ago simply because of what the product did for me on a sprained ankle. I can afford that risk if BIEL tanks and would love the reward if and when it receives FDA approval. If my $25K helped someone make a payroll or get them closer to FDA approval, I'm happy to do it.
The question I pose is a simple one; are the 3 groups of winners if BIEL receives FDA approval not the users, all shareholders and the fellow "Andy" everyone talks about? And what happens to the naysayers and the short-sellers if it gets FDA approval and takes off?
Does anyone have any thoughts as to where it might trade to with FDA approval? Thanks
I bought $25K worth 10 days ago simply because of what the product did for me on a sprained ankle. I can afford that risk if BIEL tanks and would love the reward if and when it receives FDA approval.
The question I pose is a simple one; are the 3 groups of winners if BIEL receives FDA approval not the users, all shareholders and the fellow "Andy" everyone talks about? And what happens to the naysayers and the short-sellers if it gets FDA approval?
Doeqs anyone have any thoughts as to where it might trade to with FDA approval?
I certainly have no wish to get into a he said - she said with you UKSausage. I did not state anything as you imply; I quoted the Health Canada website.
You stated a personal opinion that the FDA is the only regulator in the world to focus on safety and efficacy and that no other regulator focuses on efficacy - I say that personal opinion is incorrect and misleading. Some may find that difficult to accept, most would not and I expect you are in the latter group as you are obviously a person of intelligence.
QUOTE
Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety. UNQUOTE
Sooooo, the fact is that Health Canada states its role as "ensuring you have access to safe and effective drugs and health products." And further states, "Our highest priority in determining the balance (between those two) is public safety." Separate statements, safety highest, on balance. All good.
New fact-old news - there is most probably not a pharma or device company globally that does not grind its teeth and smile at the same time when dealing with the FDA because of time and outrageous expense in obtaining approvals. On balance, the FDA must be made up of thousands of dedicated and responsible experts and administrators.
The results? No melamine in a baby formula as happened in China, under its regulatory process of bribes and whoyaknow in the PRC communist party. An issue which led to a couple of suicides and executions of Chinese administrators.
Let's hear it for the FDA and Health Canada and safety and efficacy - isn't melamine what kitchen counter-tops used to be made of? Pulse therapy I am finding has been around a long time. I know ActiPatch worked on my sprained ankle. Canada is the US' biggest trading partner with a 3,000 mile long unprotected border and 1st world in every way. It is not a 3rd world banana or sand dictatorship handing out regulatory approvals for bribes. I told my doctor I was using ActiPatch, he was amazed and looked into it for me. He stopped when he saw my ankle 3 days later. Good enough for me. And isn't there a BIEL product already approved for post-opthalmic surgery, I think I read that somewhere, maybe here?
Thanks for the constructive reply GBull, but to the UKSausage message - any company or country deserves reasonable research before posting. I know you will take this as constructive, being a 'Bangers & Mash' kinda guy......re your post on regulatory objectives.
You actually stated as gospel that the FDA is the only health and drug regulator in the world to focus on safety and efficacy and the rest of the regulators globally only focus on safety and NOT efficacy??? Didn't ring right.
Before I read the GBull answer and suggestion to research I took this this excerpt from the Health Canada website - right off the top - first sentence of first paragraph speaks to safety and efficacy - seems to be in 180 degree conflict with your statement.
QUOTE
Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety. UNQUOTE
I agree with earlier wise post that this may be a new FDA product category and they must get it right to exclude the hustlers and charlatans, but I know BIEL is not snake Oil at $1 a bottle - personal experience on a badly sprained ankle - doctor couldn't believe the pain control and the healing process - that's efficacy!
Golden Bull - would you please help me on Health Canada approval?
I found the following article while checking around re the FDA approval process for BIEL: site name www.outrageousbus.com
Advances in Bioelectronics FDA approvals
Posted on December 18, 2011 by admin
Bioelectronics described its existing counter, and the renewed application of products:In addition, the company plans to introduce a new product 510 (k) application for approval of an alternative over-the-counter products for temporary relief of pain associated with muscle aches and pains. Equivalent Korean ActiPatch recently approved by the FDA for the treatment of muscle pain.
A request for new wound care products will help treat post-operative pain and edema. This indication of the wider use of tags allows all medical specialties, including specialists in chronic wounds, to prescribe products with RecoveryRx trust.
In order to remove its products from menstrual pain relief, bioelectronics formally requested the change in its application from a 510 (k) of section 513 (f) (2) a review de novo. The request for classification is supported by further research and clinical evidence demonstrating the efficacy of treatments such as electronic medical therapy effective for dysmenorrhea. Last week, Health Canada issued a license to market the therapy to ease menstrual pain in Canada.
Bioelectronics Corporation (PINKSHEETS: BIEL), developers of innovative topical pain medical care, has announced it is strengthening its applications in the United States with the FDA and the results of further research to better articulate its classification of products, and to improve claims his pain patented products.
The application produces ActiPatch 510 (k) for the treatment of musculoskeletal pain is still being reviewed by the FDA. Bioelectronics Research provides the FDA and additional documents in support of this authorization.
Two new product applications, FDA will significantly expand this product line. RecoveryRx products are currently approved by the FDA U. S. only for the treatment of the following blepharoplasty, hampering U.S. sales and marketing for the medical specialties other than plastic surgeons.
“The FDA approval process is long and difficult, especially for unique products and innovative, but we are confident that our results of further research and product options, we’ll succeed,” said Andrew Whelan, President and CEO of bioelectronics . “We intend to provide such data to the FDA in the United States to complete applications and obtain additional markets for our new residence. After all, we have already sold over 200,000 units through the world safely and effectively.END
Golden Bull - can you please help me understand why Health Canada, presumably the FDA for Canada, approved the BIEL product Allay for menstrual pain ahead of the FDA here? I thought the US was trying to regain the leading edge on innovative products after the Japanese economy collapsed. What gives? Thanks very much
Wondering if the 500K share drops are management hedging against go or no-go with the FDA? I'm pretty new as a BIEL investor and would like to buy more based on my experience after ActiPatch was prescribed to me for a badly sprained ankle and seeing the patent in China. BIEL's products mean pain and mild, even serious inflammation remedies drug free - I can't speak to the Allay product for geneder reasons, but if it can do for women wehat it did for my ankle, PMS etc is a thing of the past and the drug companies and doctors will be the poorer, women and consequently men the richer! Can anyone help me please - I cannot understand why anyone would liquidate while there is an FDA appl answer pending??? Unless it is MMakers playing for tenths of a cent??? How short-sighted Thanks a lot
EMPT works and is part of the drug-free future. I read up on it on the suggestion of my doc. I used ActiPatch for a week on a sprain, couldn't believe the results and just bought stock.
The FDA knows such devices are the comers and if BIEL gets its approval, the 30 cents posted earlier will be the shoulda, woulda, coulda price, as it blows through a buck, just my opinion, but my tennis sprain healed up in exactly the time the doctor suggested - about half the normal time and no painkillers!
I read about the patent in China, do they have a distributor there yet?