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I wouldn't have thought of it either lizanne, had it not been for BIEL, the FDA and iHub and its BIEL posters. Many of the "Good Guy" (and gals, yourself included of course) have opened my eyes, going back to about 2010-2011 long before I signed up here. We had no choices then, actually even now, for drug-free, side-effect free pain management in this country. I don't much care what happens anywhere else until I can go into Walgreens and buy an ActiPatch. Not to fully support this paradigm shit in pain management is almost un-American as the continued over-use of drugs continues to hurt and kill us in our country. We don't have to go to war anywhere to solve someone else's latest political issues, we are proving we are able to kill ourselves quite efficiently right here at home. Look up the data on Tylenol 3's and see the warnings - Tylenol 3's!
If 80% of the painkillers consumed today globally are consumed here in the US, then here's a little pearl - a 2003 study showed that Tylenol 1, 2, 3 and 4 controlled 35% of the North American painkiller market. That of course would include Canada and Mexico, but so what!
Annnnd, straight from Wikipedia, "acetaminophen, including Tylenol, causes three times as many cases of liver failure as all other drugs combined,[20] and is the most common cause of acute liver failure in the United States, accounting for 39% of cases." Must be careful when thinking about the last numbers, that's all acetaminophen, not just Tylenol, but, again, so what! Drug-free, side-effect free, smart, common sense, looking after Americans.
Just another piece of the puzzle Yankee.
Would be perfectly in keeping with the relatively quick speed of the FDA in educating itself on PEMF/SWT, hiring the 25 more people it said it would, the public meeting it called, the Proposed Order it made, asking for comments and so on, if the FDA and Washington and the AMA were all working in unison, for once, in giving the American people pain management options that are non-addictive. If so, watch for political interests from one or both parties to start supporting the process big time in the media. I see taking credit for supporting drug-free and side-effect free - non-addictive as a huge vote getter. That, in my opinion, would be called responsible government and medicine working together for the good of the American people.
Just dealing with the many millions of prescriptions written by the VA doctors for pain management for our vets would be an amazing public service for them, and their families, and save many more millions of dollars. Ask the wife and children of any vet hooked on pain medication if they would like a drug-free alternative. Thoughts?
To both you and yankee for his terrific post, lizanne
Yankee was understating the role of the FDA saying it was the integral part of relieving the opiate/analgesic issues plaguing our nation. The FDA is the only entity that can make it happen.
Yes, they are steering the process of creating the Class II category for PEMF/SWT, but one must reflect on the journey. From a flat-out "no" just a few years ago, to an in-agency study, admitting they were under-powered, hiring more scientifically qualified staff, Proposed Class II, public comments are in and assessed, and we await the decision.
Meanwhile, the little company that can from Maryland keeps going forward, ActiPatch being retailed in Boots in the UK; Walgreens essentially owns Boots. Anyone now not thinking there is momentum here, sell your shares, get out while you can.
I did a cursory check of the 4 companies that made comments to the FDA as a coalition before the comment period closed May 21. To the best of my knowledge, none of them, unlike BIEL, is a publicly traded entity, although I can't comment about who may in turn own them.
They also seem to be marketing specific treatment area devices, whereas BIEL has more diverse products in its basket and is retailing. I say that makes BIEL's ActiPatch and ALLAY the best of a small select bunch. Patented, drug-free, side-effect free.
Do you tire of the other moniker??? Not sure you can do that phu nhân. A little confusing. Make sure you still get the BIEL Investor Updates.
Hey Mary
Very professional Investor's Update today - I know 57 Chevy posted it, but observe that there is none of the vague rhetorical hype we have seen in the past, or flailing around regarding upcoming FDA confirmation of new Class II for BIEL type devices. Just forward momentum building facts.
By the way, I did review the 'Try It and Tell Us' program BIEL and Boots are running in the UK. Very positive stuff and well worth the read to get the feel of what is happening in the UK market. Thank you again for pointing it out to me. For those who haven't reviewed it, the program is mentioned in today's Investor Update.
Best to you and yours over the 4th festivities
http://www.bielcorp.com/investors/investor-updates/
Hey Mary - tks vm for this. Just catching up and saw your earlier re Facebook.
I was just chuckling to myself about how it seems the FDA now has the BIEL science so nailed, after coming from admitting they needed to strengthen their forces in the PEMF and SWT field and some people still don't get it that the FDA is truly running the show with its efforts, research and Proposed Order. A couple of weeks ago, I read the Proposed Order again beginning to end and was admiring the wordsmithing of it. I then moved the document into Word and edited it into a 'Final Order' format in under 15 minutes. I sent it to two of the very knowledgeable Good Guys here back-channel and got some funny responses because it looked perfect!
"Simpsonly, does this mean what I think it does?" and, "Where did you find this?", and a few more equally funny questions and comments. Told them what I had done. Suggest you read the Proposed Order, you will see what I mean, the lead writer and team members drafted a document of beauty! Let me know what you think please.
Thanks again for the two suggestions. Cheers
Absolutely? that the statement that there was never an offer turned down by BIEL was factual? I'm from Missouri, show me the facts that there was never an offer turned down by BIEL. Never mind asking for factual proof that there WAS an offer turned down, the request was politely made for proof of the stated fact that there was never an offer made or turned down - 180 degree difference. . . .
Andy NEVER turned down any offers.
That appears to be a statement of fact?
Hey sausage - your BIEL investment strategy seems solid .
I would only caution that I sense momentum, with the FDA and the industry seemingly on the same page, in wishing to provide U.S. pain sufferers with a clear path away from the scourge of chemical analgesics here.
I believe RecoveryRx was approved for Rx sales in just a few days or weeks. The FDA now 'gets' the science, efficacy and zero side-effects safety of the BIEL type products. It must be interesting inside the FDA on this project. I can hear it now, "Boss, I'm telling you, there's less risk with an ActiPatch than the combined electronic exposure to your cell phone, your watch, your electronic car key, that silly flashlight you carry with your keys, the phone on your desk and the lights in your office, I can't find anything negative about ActiPatch, it ain't there!
A few years ago, it was, "We're not quite sure what we've got here and this OTC application is all about thermal, so there must be risks, yet to be defined."
The FDA was so honorable that it was critical of itself in an internal detailed analysis, saying it needed more knowledge and horsepower in this field and then followed through on it's statement that it need to bolster its professional forces, concurrently with a powerful trend change of government, media and the American people shouting in unison that the time is past for dealing with the chemical painkillers flooding our country - more than 80% of global chemical painkillers consumed in the U.S.? By any standard, that's just foolish and my sense is that DC and the FDA are realizing that NOT to give citizens the opportunity of drug-free pain relief is just wrong. I will even go out on a limb here, which I go to great lengths to avoid, and say that if I'm an American politician, I want to be loudly and clearly identified with the strong advocates of BIEL type products. Everyone knows one or more relatives with chronic pain, it's just time we deal with it more effectively than popping more pills.
So, be prepared for a possible quick decision sausage, not saying it will happen, but no chemicals, non-addictive and not one negative side-effect just does not change with the passage of time, or more regulatory assessment, or trials. BIEL's products are both clean and efficacious, does it get any better, especially with the FDA now on-side by publishing it's Proposed Order with its numerous positive phrases? I think this is now a matter of amending the Proposed Order and simply getting 'er done.
StockinUp - I have no substantive argument against anything you've said! I so wish I had a crystal ball, the hell with mad's little birdie. Thank you for your thought provoking post.
Just having fun off justwin's post 40802 mentioning $20 a share, 10 cents would be a good start. . . . . @6 Billion shares that's a market cap of $600 Million - not insane given the potential I described in posts earlier today.
Hi band - C'mon, I think I'm in my right mind and I think I would hold my shares on the way to $20, but I also think my right mind would sell them at between $4 and $5. Someone else can have the other $15 :)
Some cool math edbi.
Assume for just a moment there is another person like me who wishes to invest $450,000 in the future of BIEL @ $ .0018 - that's 250 Million shares - a quarter of a Billion. So, for $450K, one owns 3.1% of BIEL, based on 8 Billion shares or 4.2% of BIEL based on 6Billion shares. Who cares, really, let's use 8 Billion shares.
Assume both of your SP number forecasts are correct. The investment of $450K would be worth $12.5Million at 5 cents and $25Million at 10 cents. I'm not stupid enough to post stating that either of these prices is any more than speculation, but neither can anyone else post that they will not be reached as that too would be mere speculation.
What I do know for a fact is that I made a lot of money in 2009 when BIEL ran to over 12 cents in a few months on much, much less horsepower than it now has, thanks to the FDA's own statements and "its own initiative" and proposed order to allow BIEL's products as Class II. The FDA was silent in 2009 and for me that was the missing link leading to selling at less than 12 cents.
What I also know as factual is that when it started to run in 2009, logic did not prevail, BIEL simply stated it was going to apply for approvals for ActiPatch. As I say, the FDA was silent.
This time, the FDA is everything but silent. Public hearing called by FDA; FDA Proposed Order "based on new information" and "FDA makes this Proposed Order on its own initiative", FDA requests public comments closing May 21st. The FDA is among the most intelligent and highly educated large groups in our country, they are not fools and now they know the device category BIEL is in, whereas they were big enough just a couple of years ago to state publicly they were not conversant enough on the science of BIEL's product space. Well, they are now, thus my identifying this baby as much like a long freight train, can't stop it.
I guess if I were trying to acquire a few billion shares cheaply and quietly because I get the science and I'm a corporate entity wanting to do a licensing deal with BIEL for the U.S. market, or I'm trying to lower the share price down so I could invest $10,000, I would be hammering away at BIEL negatively, but I'm not. If I were, that would be a smart way to do it, I guess. But, it's really hard to stop a freight train once it's rolling.
Thanks bieliever - Can anyone now assert that the team of Boots and BIEL is not successfully 'Branding' Actipatch in the UK?
Second best part about that BIEL PR today is the statement that ActiPatch costs the consumer $ .04 per hour of therapy. Does that not make BIEL a substantial financial threat to a lot of other pain products? Man o man, no wonder the FDA has stated to the public that proposing to make BIEL's and other's devices Class II was on its own initiative. They may seem to move slowly, and that's because scientific research and cautious approvals are prudent and good for us but the FDA is coming like a long, slow freight train - no stopping it.
Great work yankee - thanks very much.
I agree with your paradigm shift in healing theory of BIEL and things "becoming" harmful, or not, for us in a single generation.
Your post conjures up a few thoughts:
Analgesics, especially OTC like Tylenol; who thought in 1955 when Tylenol Elixir was introduced for kids and there was not a hint of harm until 1960, and then only a quickly dismissed hint.
Quote - Wikipedia.org:
"The dangers of acetaminophen, especially in combination with alcohol, have been reported in the medical literature since the 1960s, although they were not always disclosed on the Tylenol labeling and packaging. These dangers were reported in a September 2013 episode of This American Life entitled "Use Only as Directed" and in two investigative articles in ProPublica.
This American Life reported that "acetaminophen, the active ingredient in Tylenol ... kills the most people [of any over-the-counter drug], according to data from the federal government. Over 150 Americans die each year". This assessment conflicts with assessments in the medical literature, which suggest that the most commonly used alternative to acetaminophen, non-steroidal anti-inflammatory drugs (including naproxen, ibuprofen, and aspirin) cause 3200 deaths and 32,000 hospitalizations each year due to gastric bleeding alone. Other estimates place the number of NSAID-related deaths from gastric bleeding as high as 16,000 per year. The apparent discrepancy may arise because the PBS assessment relied exclusively on reports from poison control centers. Such centers are unlikely to report gastric bleeding episodes as NSAID-related, as such episodes may be caused by factors other than NSAID use, and are associated more closely with chronic use rather than acute overdose.
ProPublica reported that the "FDA has long been aware of studies showing the risks of acetaminophen. So has the maker of Tylenol, McNeil Consumer Healthcare, a division of Johnson & Johnson" and "McNeil, the maker of Tylenol ... has repeatedly opposed safety warnings, dosage restrictions and other measures meant to safeguard users of the drug." This included warnings of liver damage and warnings about using acetaminophen in combination with alcohol. This is especially dangerous because of acetaminophen's narrow safety margin. ProPublica interviewed a man who had liver failure after using Tylenol in the recommended dose and drinking two or three glasses of wine, at a time when the Tylenol label didn't mention any dangers of drinking.
Acetaminophen, including Tylenol, causes three times as many cases of liver failure as all other drugs combined, and is the most common cause of acute liver failure in the United States, accounting for 39% of cases. Unquote.
Who knows what the real damage numbers really are currently? Almost 100% of the global consumption of oxycodone and 80% of all global analgesics are consumed here in the U.S.? That's really insane!
Next thought that comes to me is sugar, in all its forms, sodas, fruit juices, fast foods, etc., leading to obesity, diabetes, heart, et al.
Finally, Unprotected anything. . . disease, flood control in our cities, drugs, pollution, many, many areas where protection can be ramped up to avoid harm. . .
You've nailed it yankee, BIEL may very well be a leading edge paradigm shift that the American people can then communicate verbally and by messaging across our nation in < a month. With these three areas of harm, we are doing ourselves in, so I say we may be hungry for solutions as a nation, thereby supporting your theory.
Best way to communicate good news coast to coast is CNN, CNBC, Fox, Oprah, Helen, followed by the female telegraph system involving kids activities, over the back fence, shopping, church and coffee - what woman in her right mind who is suffering from the aches and cramping pain of menstruation will not seriously consider and chat about ALLAY for herself or her daughters? No side-effects, no drugs and get on with your day pain-free? I say ALLAY could well be the biggest element within BIEL's potential paradigm shift because when something is in woman's best interests and there is determination, there is no greater force today!
Many thanks again for your thought provoking post.
Don't believe I've seen this information before 7up - If $30K a month is the correct burn rate, then for sure all the selling is either for accumulation purposes by an acquisitor / potential BIEL U.S. Licensee or, MM's churning the stock - I still say it's the former. I wonder how many 100's of millions of shares have traded since January
Hey veto - I may be able to help with that.
FDA releases its order making BIEL products Class II, requiring an Rx from your doctor, but at least the ActiPatch products will be available in the US. That solves one issue - no drugs, no chemicals, no side-effects - I believe you will then be "in the money" as you put it.
When BIEL submits its 510(K) application requesting OTC designation, I believe that initially there will be another pop and the application pending FDA decision will keep you "in the money", perhaps not all, but it will certainly help.
I ask you to share with us your thoughts as to what will happen to the share price, if, as and when BIEL receives FDA approval for its products to be sold in the US OTC. Please, also consult your wife, one of the wisest women I know of after the advice she gave you. In the money? No question in my mind, I would just like to know what you think as well.
Cheers
Hey Mary - thank you - just waiting patiently for the news.
The facts are all in now.
I focus on the words of the FDA - let me paraphrase as I have no time to edit the quotes:
"FDA is proposing an Order to make these devices Class II"
"Based upon new information"
"to correct technical information" and best of all. . . . .
"FDA is doing this on its own initiative"
Gotta love it.
The new information they have is, among other things, that BIEL's products and those of others in the space are - drug-free - side-effect free (unless you tape an ActiPatch over your eyes and go for a walk) and there has never been 1 negative comment as to efficacy. I also love that BIEL's products are patented.
What else is there to say? I guess if it were my style, I too would be pounding the atmosphere with negativity in the hopes of buying stock more cheaply before the news is released, but it is not my style and I'm too busy. Ergo, we wait patiently.
Hey Limit - Only 1 individual talking reverse split and it is not Whelan the BIEL CEO
For balance, BIEL is a Maryland start-up company with patents on its products forming its IP and is cleared for OTC sales in many countries, including Canada and the UK - retailed in Boots and on Amazon.
Its products are drug-free, side-effect free pain management devices that also promote healing.
The FDA has stated publicly that it is proposing a new Class II for BIEL's products and other devices and is doing so on its own initiative because of new information.
BIEL will immediately thereafter submit it’s 510K application to enhance its new Class II designation requesting FDA consideration for OTC designation.
Today 6Billion shares at around $.0020 is a market cap of $12 Million, which is laughably low, given BIEL's potential and then FDA ramifications. Anyone thinking that's too high a value to place on BIEL should look elsewhere for opportunity.
What the market cap of BIEL may be, with 8 Billion shares, or more, out there, is anyone’s guess. Will BIEL merit a $300Million cap rate? At 8billion shares that would be a share price in the near term of $ .0375. An acquisition or US agreement with a large pharma with an existing pain field force improves that, of course. All speculation, but my opinion is there are good days ahead for BIEL.
My opinion remains that someone, possibly an acquisitor, is buying BIEL shares because the share price is low and once this train leaves the station with a new FDA Class II SWT device class these prices will be a very distant memory.
Hey sausage - link below, particularly Chapter 7 gives a snapshot of what the FDA has and is doing to bolster the devices division. Just info, nothing more, but it does show to me that the FDA is professional to publish where its shortfalls are, the self-criticism of those shortfalls, and how it planned to deal with them. Impressive.
CDRH full time equivalent civilian staff count up from 1277 in 2010 to 1316 in 2013
http://www.washingtonpost.com/r/2010-2019/WashingtonPost/2012/11/19/National-Politics/Graphics/PEW_FDA_Public_19112012.pdf
Just general info that may keep us all on the correct path based on facts:
1 BIEL is a small start-up company with patents forming its IP and is cleared for OTC sales in many countries, including Canada and the UK;
2 Drug-free, side-effect free pain management devices that also promote healing from general pain to menstrual pain and cramping - see the BioElectronics website;
3 FDA is in the final phase of issuing an Order opening the doors for such devices to move into Class II designation;
4 BIEL will thereafter submit it’s 510K application requesting FDA consideration for OTC designation;
Speculative:
5 Today 6 Billion BIEL shares at around $.0021 equals a market cap of $12.6 Million. Anyone thinking that's too high a value to place on BIEL should look elsewhere for opportunities.
6 In future, what the market cap of BIEL may be, with 8 Billion shares or more out there, is anyone’s guess. My opinion is someone, possibly an acquisitor, is buying BIEL shares because the share price is low. In my opinion, once this train leaves the station with a new FDA initiated Class II SWT device classification, these prices will be a very distant memory.
Hey 7up - a couple of observations for you to consider. I don't think FDA is going to consider putting SWT devices into either Class I, II, or III. Seems to me they are proposing putting them into Class II from class III. Period.
Note how smoothly the proposed order is drafted - they call it a technical correction being proposed on its own initiative (the FDA's). It doesn't credit or blame any party for anything, just gets on with the business at hand and finishes off beautifully by asking manufacturers if the FDA is giving them enough time to submit their 510(k) applications after the final order is published. On reading all this it also seems to me the recipe is clearly set out as to what manufacturers must do. Further, it appears the only differences between the proposed order and a final order may be a little tweaking here and there as the FDA may deem appropriate based on the comments received. Sorry for the length, the FDA wrote this and published it into the public domain. Not difficult to draw reasonable and truthful conclusions from all this. Thanks for posting the link again.
http://www.gpo.gov/fdsys/pkg/FR-2014-02-20/pdf/2014-03594.pdf
Here are the paragraphs I found most interesting - just food for thought.
Federal Register /Vol. 79, No. 34 /Thursday, February 20, 2014 / Proposed Rules Page 9671
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2012–N–0378]
Physical Medicine Devices;
Reclassification and Renaming of Shortwave Diathermy for All Other Uses
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order; technical correction.
SUMMARY: The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a
preamendments class III device, into class II (special controls), and to rename the device ‘‘nonthermal shortwave therapy (SWT).’’ FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements.
DATES: Submit either electronic or written comments on this proposed order by May 21, 2014. February 21, 2014FDA intends that SWD devices for all other uses must comply with the special controls and must submit a premarket notification (510(k)) within 60 days after the effective date of the final order. See Section XII for the proposed effective date of a final order based on this proposed order.
Federal Register /Vol. 79, No. 34 /Thursday, February 20, 2014 / Proposed Rules Page 9675
FDA believes that the following special controls, in addition to general controls, are sufficient to mitigate the risks to health described in Section V:
1. Components of the device that come into human contact must be demonstrated to be biocompatible. These devices can contact users’ skin
directly; therefore, a demonstration of biocompatibility would mitigate the risks of skin reactions.
2. Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use
environment. The requirement to demonstrate electromagnetic compatibility would, in concert with other special controls, help ensure the
mitigation of discomfort, pain, and tenderness resulting from burns to the skin due to excessive energy deposition by preventing electromagnetic interference with device hardware and software. In addition, this requirement would ensure the device does not interfere with other electrical equipment and would also ensure that both operators and users are properly protected from electrical hazards such as electrical shock.
3. Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. This requirement would mitigate the risks of cellular or tissue injury, electromagnetic interference, tissue necrosis and burn,
and thermal injury from implanted leads and implanted systems. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
- Peak output power;
- Pulse width;
- Pulse frequency;
- Duty cycle;
- Characteristics of other types of modulation that may be used;
- Average measured output powered into the RF antenna/applicator;
- Specific absorption rates in saline gel test load;
- Characterization of the electrical and magnetic fields in saline gel test load for each RF antenna and prescribed RF antenna orientation/position; and
- Characterization of the deposited energy density in saline gel test load.
4. Documented clinical performance testing must demonstrate safe and effective use of the device. This requirement would mitigate ineffective treatment.
5. The labeling must include a detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications. This requirement would help mitigate the risk of adverse pregnancy outcome, risk to children, thermal injury from implanted leads and implanted systems with leads, electromagnetic interference, electric shock, tissue necrosis and burn, adverse tissue reaction, and ineffective treatment.
Table 1 shows how FDA believes that the risks to health identified in Section V can be mitigated by the proposed special controls.
TABLE 1—HEALTH RISKS AND MITIGATION MEASURES FOR NONTHERMAL SWT
Identified Risk followed by Mitigation Measure
Cellular or tissue injury - Non-clinical characterization and performance testing.
Electromagnetic interference - Electromagnetic compatibility testing; Non-clinical characterization and performance testing; Labeling.
Tissue necrosis (tissue death) and burns - Non-clinical characterization and performance testing; Electrical Safety Testing; Labeling.
Electrical shock - Electrical safety testing; Labeling.
Thermal injury from implanted leads and implanted systems with leads - Non-clinical characterization and performance testing; Labeling.
Adverse tissue reaction - Biocompatibility; Labeling.
Adverse pregnancy outcome - Labeling.
Risk to children - Labeling.
Ineffective treatment - Clinical performance data; Labeling.
In addition, under 21 CFR 801.109, the sale, distribution, and use of these devices are restricted to prescription use. Prescription use restrictions are a type of general controls in section 513(a)(1)(A)(i) of the FD&C Act. Also, under 21 CFR 807.81, the device would
continue to be subject to 510(k) notification requirements.
9676 Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Proposed Rules
XII. Proposed Effective Date
FDA is proposing that any final order based on this proposed order become effective on the date of its publication in the Federal Register or at a later date if stated in the final order. FDA proposes that nonthermal SWT devices must comply with the special controls and must submit a 510(k) within 60 days after the effective date of the final order. FDA requests comment on whether 60 days is an appropriate time to allow manufacturers to prepare and submit 510(k)’s for these devices.
Perfect - then at 5 cents when BIEL products are made Class II, investors can decide whether they wish to buy or hold shares until BIEL receives an FDA decision as to OTC based on the 510K or whatever it submits.
Apologies, meant to say menstruation, not menopause.
Hey yankee - I was trying to very conservative when throwing out the numbers - "more than 90%" and "more than 95%" in several posts. I have seen various numbers from >95% to >99% and indeed it is shocking. There are many levels of pain and it is a given that ActiPatch cannot deal with severe pain but it will help many tens of millions of chronic mild to medium pain sufferers, to say nothing of BIEL's ALLAY helping tens of millions of women who suffer every month from the pains and cramping of menopause.
Thiose numbers are my opinions as to the US. Now go global. Haven't heard of any complaints as yet about BIEL products causing anyone to OD, or to become addicted. I guess there are substantial ramifications for doctors who when faced with a patient 'asking' for drugs for pain can simply suggest they go buy an ActiPatch. The VA doctors should be listening. The good news about drug-free and side-effect free just goes on and on and I suspect this is what the FDA is fascinated by and positive about. BIEL miss-hit the ball first time around, but with an educated and willing FDA and the IP/patents, this will do well for all. I am very content to ignore the nonsensical bashers and await the FDA decisions.
And amended as the FDA may see fit from time to time in working with BIEL and other parties in this device space. All based on efficacy and public safety, not premature speculation, which is usually worthless and often driven by ulterior motives!
I expect the company politely requested that its products be pulled from Ebay. It only makes sense as they were being peddled by a lady Chiropractor here in the US and a couple of her emails were posted here on iHub. I expressed at the time that I found the situation disconcerting for BIEL. If I were Whelan I would have made that happen instantly to show FDA a responsible regulatory profile. If that is the case, well done BIEL.
On the other hand, the FDA may have shut her down and requested the pull by Ebay, in which case I commend the FDA. I predicted that talking too much would cause some whiplash and it seems to have done just that. Good, I hope she also got a stinging cease and desist letter from the FDA. Try to circumvent the system - get whiplash - buy ActiPatch at Boots - ActiPatch is good for whiplash. No drugs, or side-effects, just pain relief.
I did find the petpatch on Ebay
Thanks Super. I too have little time or patience for the nonsense. This is going to evolve, as it will, with bright people managing the process and without the conjecture and negative bias that seems to be so prevalent. Total waste of my time and why I continually thank iHub for the 'ignore' option built into this website - who has time?
BIEL is now OTC, essentially throughout the free world and exposed to billions of people on a financial shoestring by a little start-up company in Maryland. It is sold in Boots in the UK, one of the largest pharmaceutical retailers in the world.
The folks at the FDA are at the top of the regulatory intellectual food-chain and, in my opinion, have no desire, or intention, that we remaining considered as out-of-step with the rest of the world, particularly when the US government and our people are deserving of radical changes with respect to the US consuming 80% of the world's painkillers and high 90's % of the global oxycodone. Oxycodone has its place, I'm sure, but like all products derived from the poppy, it is being abused millions of times each year.
With Oxycodone having been around since the turn of the last century, 1916, to be precise, is it not time for us to get smart and stop the drug cartel we have in our midst hiding under the guise of medicine and involving Rx and OTC chemical painkillers from Tylenol to Oxycodone and all in between? Surely, we Americans are better at looking after ourselves than this. It is almost impossible to go a day without reading or hearing of this American travesty. It's time.
BIEL and like companies sell drug-free, side-effect free pain management devices. BIEL's devices are patented. What's to even discuss?
Thank you sausage for your level-headed common sense. Between you, edbi, super and hooker, the thoughts and opinions of every Good Guy I've seen here have been succinctly portrayed, although quite exhausting to read the tomes put forth in opposition. At no time did anyone think that the new class of devices would mean BIEL would receive automatic or rapid OTC blessings from the FDA. The company will do whatever it must do to advance its business. Thanks again.
Seems you've gone to tremendous effort on behalf of someone, are you able to share with us who?
Thanks edbi - your sophisticated writing style precedes who you are.
Thank you Truth - good to see your intelligence and common sense prevail over the nonsense.
Sorry Pink and 7up, didn't mean to intervene in your discussion, just seemed to me there is much latitude for speculation and none of us is wrong, at the moment. Only thing I know, with absolute certainty, is I don't know how much financial upside there may be. But, I believe, with strong certainty, that the BIEL future will be positive, if they manage the application process well, since it is the FDA that has now taken the initiative of creating a new class of SWT devices. The American people suffering with pain will be the primary winners, BIEL, and its shareholders,a close second. Through FDA approval, there will naturally be higher sales internationally as well. Drug-free, side-effect free pain management, OTC? Who in their right mind would bash those attributes?
Go carefully 7up, I suspect that the company may have seen much less than the Sticker Price of $30 from the Dr. Oz exposure. As is the case in so many of the TV shopping cases, the company may have received a net of $5. I just don't recall a sales figure of $1.8Million, or thereabouts. If your point is that the potential is there for a large market cap, I totally agree. I posted a hypothetical calculation months ago and it surprising how conservative sales estimates yielded an attractive cap number. Sorry, I don't have time to research back to that post, but I recall several respected fellow posters agreed with my conservative approach and I came away thinking that over time BIEL could be quite a winner.
I think you do understand it perfectly Super - I know I kicked these aspects around the posting court a few times; of Whelan's team's priorities and focus needing to be on the 510K app stages and the data to be submitted with it. I also rambled about delegating FDA/BIEL work and communication responsibilities to the most appropriate members of the BIEL team.
Well said Casper and much appreciated. You have forgotten more about the electronics than I'll ever know.
So, having addressed at least a dozen topics, I'm still wondering about your CV on management experience in Pharma/Medical projects having to do with the FDA and M&A experience which you left unanswered? By the way, $7.8Million at this game really is chicken feed. We've seen a couple of Billion shares change hands in the last few months - I it MM's churning or someone buying? Thanks
Thank you yankee for your gracious appreciation.