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Thank you omis, for your kind words - I too quietly read the iHub posts for a long time, having been involved for the same length of time, actually longer. Then, I felt it was important to have balancing counter-arguments to the growing punitive posts and angry gibberish, when I knew the content to be misleading. Probably, some folks feel my input is gibberish too, which is fine with me, as long as there remains balance, so people read the truth, and otherwise. Thank you again.
Agree with much lf what you wrote Stockin, but permit me to comment on the same olds, same olds in the ER and if you're correct that they were seeking drugs.
Whether you are correct or not, it is well published that medical drug painkillers are being abused by dumb over-prescribing doctors and hooked patients and/or manipulative users with no pain issues hustling them, as well as those patients who are not hooked, but who have legitimate pain and are also being harmed.
Just keep watching my friend. I predict that the AMA and insurers are going to come down on doctors big time to reduce every one of those aspects. Doctors will not want the exposure, vis a vis either their right to work as a result of the AMA disciplining them, or insurers and users families suing them with litigation lawyers all over everyone.
All that in addition to the fundamental moral issues of just not over-prescribing drugs to addicts, or just people who have lost their way because of painkillers. It's a complex issue and solutions will be difficult, very costly and take time, but BIEL and the FDA can play an incredibly significant role in abating the pain drug scourge that is harming Americans.
Have I been positive on the FDA's role in all this? You betcha. Can I be cynical about the past, forget it, it's gone, waste of time lugging that baggage around, let's move forward.
Sounds to me 7up as if Boots and BIEL are going to rule the UK. What a great marketing strategy and BIEL gets the use of the proven Boots marketing division. Build a loyal user base in the entire UK for a pain management system? Brilliant.
ActiPatch users suffering mild to medium intermittent or chronic pain will never return to chemical drugs when they discover ActiPatch works for them with zero side-effects. The UK had a population of over 64Million people in 2013. This is the best news I've seen in some time 7up. If it proves successful, imagine Walgreens, who now own Boots, doing the same thing in the U.S.? Thanks for the find!
And a resulting $28.8Billion market cap - amazing mad
I would be very, very happy with Biel at a Market cap of $360Million or 6 cents a share on the announcement of the new classification by the FDA and out of my mind ecstatic at north of a billion. say 1.5B or 25 cents.
I would expect it to go higher should BIEL get its OTC approval of a 510K application, but $3.45?, nope that is not on my radar at this time.
I just had a brain twitch from past FDA information releases mad. Let me paste in some info here for you to think about. May Seems to me there may be one very positive thread through all this and that is that the FDA may have a very responsible and positive sense of urgency in dealing with the media, political and common sense pressures concerning overprescribing and abuse of pain medications in our country that are hurting and killing Americans by the tens of thousands every year in its Proposed Rule document said the following:
QUOTE
The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of July 6, 2012. In that document, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, shortwave diathermy (SWD) for all other uses. In response to the requirements issued in the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and proposing a different action. UNQUOTE (which means you don't need to do a PMA etc.)
and
QUOTE
III. Proposed Reclassification
Elsewhere in this issue of the Federal Register, FDA is proposing to reclassify SWD for all other uses, currently a preamendments class III device, into class II (special controls), and to rename the device “nonthermal shortwave therapy.” FDA continues to review the merits of the submissions for requests for reclassification that meet the requirements under 21 CFR 860.123, submitted in response to the proposed rule. UNQUOTE
and finally, by going back up toward the beginning of the FDA release into the Federal Register, we see a small paragraph under the heading DATES:
QUOTE
Dates
Submit either electronic or written comments on this proposed order by May 21, 2014. February 21, 2014, (meaning on Feb 21 2014) FDA 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.
Addresses
You may submit comments, identified by Docket No. FDA-2012-N-0378, by any of the following methods:
Electronic Submissions
UNQUOTE
I recall the FDA asking for comments as to whether the 60 day period it was proposing, after the issuance of a final order enacting the new Class II classification would be enough time for applicants to submit their 510 (k)'s for consideration. . . . . . .
* May 21, 2013 - public meeting called by FDA
* February 21 2014 - Proposed Order and asking for comments by May 21 2014
* May 21 2014 comment period closes
* June 20 2014 - comment review completed
My point is the FDA seems like it's in a hurry-up mode in moving the new classification process along relatively quickly. Perhaps not quickly enough for investors, but quickly relative to other things it does, which often take years. To ask potential applicants if 60 days is enough time for them to file 510 9k0 applications and comment on that seems very significant to me, but what do I know. I've got an itch that the FDA may want to move the new classification order and subsequent 510 (k)applications, and then agency assessments and approvals along as quickly as possible in order to get these devices to market to help Americans take advantage of the drug-free, side-effect free aspects of non-chemicals pain management devices. What a great thing for the American people and subsequently the rest of the world that respects the FDA caution if that were the case. Hope I didn't bore you mad, but I would appreciate your thoughts on my brain itch that maybe, just maybe, the FDA are the Good Guys here. Thanks
Important intel on the sales and feedback tj - thank you
I found it manually - should have said I don't automatically see them - love the ignore option iHub provides us with. Ignore the insulting insinuation, you have nothing to defend my friend..
I don't receive nopink's posts, but I saw no reference to insider information in your post, vague or otherwise. My assumption was that you were perhaps talking about some service or something, or just kicking an idea around - none of my business and your total right to say nothing, if you so wish.
Hey BIELoney.
No reason I can think of except this has to be getting close.
May 21 comments previously requested by FDA to its Proposed Order closed. Comments received (approx. 400) were reviewed within a month + -. We are now at 69 calendar days and counting.
I've read the Proposed Order several times, beautifully drafted, and it seems to me it forms the boilerplate for the final Order.
My opinion is this train has left the station. Suggest you monitor both the 'Federal Register' and 'CDRHNew - News and Updates' sites for announcement.
Also suggest when announcement of new Class II for devices is announced it will run. How far is anyone's guess. Then, with Rx capability, BIEL then makes application to FDA for OTC. My opinion is the mere application submission will cause a rise and OTC approval, if and when received, will trigger another. If my speculations are correct, you know what to do. Drug-free, side-effect free? Given the current media and political climate of abuse, dangers, over-prescribing and drug side-effects, this should be interesting, to say nothing of helping tens of millions of Americans.
https://www.federalregister.gov/articles/search?conditions%5Btype%5D=RULE&order=newest&page=1&quiet=true
http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm
Kind of the same family, superficially to the naked eye, Jonas, but as different as brother and sister genetically and scientifically. If you feel up to doing a little research for 15 minutes, you'll easily get the differences. TENS masks pain somewhat, BIEL masks pain to a greater degree AND stimulates healing. Night & Day. Sell your TENS stock
You're most welcome M. Thank you for your many positive contributions.
I agree Stockin - extremely difficult to spot in the first place, assemble evidence, prosecute and then prove beyond . . . .
But please consider separately the FDA and drug company employees. I submit that's a much different area than the more general aspects you identify - "government scandals". Those involve elected officials, as well as government employees, and the whole gamut of companies providing all goods and services to the government and other parties not selling anything but wanting favors and influence of any and all kinds.
I was thinking earlier specifically of drug companies attempting to influence FDA staff and management and decision makers on regulatory processes and approvals. I believe the FDA debarment controls for employees of drug companies, plus potentially the companies themselves, in addition to the criminal prosecution elements, make it a different scenario. Paying a little more for a tractor or buying 50 tractors instead of 30, or paying a higher rent on a building is, in my mind, far different from overlooking a few safety issues, playing dumb, fast-tracking inappropriately, or triggering shortcuts on a drug application, and risking your senior employees never working in the industry again or your company never doing business in the US again, no?
Hey Michel - I gave you a link to what happens in the case of bribery within the Executive Branch.
Here's is a better one on what happens if you are a drug company employee and are caught trying to bribe an FDA employee - you risk lifetime debarment from ever working for a drug company! In addition to the possible felony aspects of the crime. And this can apply not only to employees of a drug company but the company itself. The link provides info that it is commonly VP's of QC or Dir's of R&D who get nailed for such things, but imagine you are the CEO of a drug company and an officer of your company is contemplating a bribe of an FDA employee. The link also provides info on generic situations. So, I maintain my opinion, J&J, GSK, Pfizer and the other large pharma branded firms or generic firms? Extremely unlikely!
http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm139627.htm
And, lifetime debarment can be enacted, not just for bribery, which is a very serious crime, not just for the recipient, but also for the giver, but for what might be considered as a relatively small issue as lying to the FDA, no bribe, simply lying! As a point of interest, there has never been a case of a reversal of a debarment. Serious stuff and to me not worth the risks associated with the crime. Would you take a bribe for a million bucks? 10 million? That stupidity is not worth the associated risks. Never mind the high integrity of FDA staff and management who would be stupid on a colossal magnitude to even consider taking a bribe. Oh, and almost forgot, I'm not a criminal attorney, but I assume it is also criminal to be involved in an attempted bribe or conspiracy to bribe, etc., etc.
Hey Michel - I think your opinion is very well thought out. However, I offer this counter-opinion.
Let's just say that big pharma had some level of undue influence on FDA staff and management, even going to what I think is the outrageous, to the point of bribery, which is indictable.
http://www.oge.gov/Topics/Gifts-and-Payments/Bribery/
QUOTE Your personal opinion, "personally, I think big pharma is holding this down, and has some people in there pockets. can't prove it .but think how much money big pharma stand to loose with this product. and the lives it will save countless in the future.this product should be a category 1 not 2" UNQUOTE.
I counter with this personal opinion - I believe big pharma players are not stupid enough to risk their careers, years of combat with the FBI, financial and public ruin and jail by bribing or even attempting to bribe FDA staff and management. No one these days is that incredibly stupid, either in big pharma or the FDA. Call me naïve, but I happen to know for a fact that anyone with any influence at the FDA is double degreed, which indicates intelligence and work ethic. Anyone at the VP level or higher in big pharma is doing very well financially.
So, my bet is that big pharma decision makers have already got their radar on PEMF/SWT and the Proposed Order by the FDA on the sound business theory that they want to be part of the coming shift away from chemical drugs. There are a number of device manufacturers awaiting the new Class II Order by the FDA. BIEL is in a fortunate position with patented devices for general use by the public on mild and medium intermittent and chronic pain issues. So, if I'm big pharma, I stay quiet so as to avoid anyone saying big pharma had any influence on the FDA issuing it Order making such devices Class II with the opportunity for OTC. Then, when the final regulatory processes are complete, big pharma player and BIEL go public with an announcement. Nothing else makes much sense to me.
Speaking of absurd Stockin, I just thought of a dangerous side-effect of ActiPatch. To quote your post re the FDA published article, "they say that it can cause DEATH when abused orally and they also point out that orally is the most common method of currently abusing . . . . . . . .
I guess part of the Special Controls to be considered on ActiPatch, in addition to keep away from small children, should be the instruction that it is not under any circumstances to be consumed orally, whether crushed or not, because it could cause choking.
I couldn't resist the irony of it all. My common sense tells me the Order should already have been published in the Federal Register. In such circumstances, I always ask myself the elementary psychology question, What's the worst thing that can happen to me?" Seems like the common sense answer for mild to medium general and chronic pain is I could be completely and safely pain-free without drugs. Imagine that being the worst!
Did I miss a chapter 7up?
By my count, the close of comments as at May 21st plus 60 days takes the timing to July 20th, not August 14th. Seems to me that August 14th would be 85 days?
A possible danger of course is using the factor that 50% of reviews are completed in 60 days. I would not make the assumption that this would happen within that 50%/60 day period - it's too optimistic.
If we knew that 90% of cases are resolved in, say, 90 days, that might be a better speculation as to probability. Of course, any such speculating must include the assumption that there will be no delays, no questions asked, no new avenues of research, etc., opened up. And, don't forget, summer vacations can delay issues what with the need to have various people sign off on approvals as well. I have found that life is rarely smooth sailing.
For some reason, I can't recall, I have the period Friday July 25th to August 22nd highlighted in my schedule as possible FDA issuance period of its Order on the new Class II it's proposing "on its own initiative". I would suggest that earlier than August 22nd would indicate that FDA is very serious about giving Americans the freedom to choose non-drug pain management that has proven beyond any shadow of doubt to have no negative side-effects and a high degree of efficacy. They are very bright, mostly highly competent people, they'll get er done and I expect the FDA management subscribe to the philosophy that it's not about who is right, but what is right. Given the attitude shifts in the media and DC about chemical painkillers, there is no pharma company on earth that is going to have any credibility to absurd positions like, "no, we don't think drug-free and side-effect free is the way to go, we think continuing on our current course of dangerous overprescribing of chemical drugs is the best way". No Chance
Like your wisdom on what gets very tiring, that's why I use iHub's ignore feature, I never see the posts I would only tire of like yourself. If I recall correctly, one can only use 5 name ignores to block specific posters for as long as you wish - should be 10!
Yup, yankee, 7up, super and jimzin should all be salivating to get their very own copy. Including you and me, that makes six in all and here is the pricing list:
SINGLE USER £1799 $3,054
DEPARTMENTAL (FIVE USERS) £2999 $5,091
SITE £4999 $8,487
GLOBAL SITE (INCLUDES FREE DATASETS) £6999 $11,882
Perhaps you should get the Global Site for just under 12 thousand bucks, includes datasets, which everyone will need. That way everyone can have a copy. . . . .
The world has gone completely nuts! For 10 bucks I could have told them BIEL is a winner!
Just so you know M, the listed price of a single copy of the report is 1,799 UK pounds or $3,054.00 USD. When you receive the copy you order, would you please scan it, create a PDF, and then send me the link privately, so I can read it? Just let me know when it's ready and I'll fire you an email address. Thanks very much. We could also sell copies of the report to all shareholders at $200 a copy.
On the other hand, you could buy another 1.7Million shares of BIEL first thing market open Monday for the same money!
I think it is a credit to BIEL that it has been mentioned in such an expensive industry tome and among such illustrious companies as those listed. Well done BIEL.
Is this it?
LONDON, Jul 01, 2014 (PR Newswire Europe via COMTEX) -- LONDON, July 1, 2014 /PRNewswire/ --
Future Prospects for Leading Companies
Pain Management [ https://www.visiongain.com/Sector/8/Pharma ] Devices - new study showing you trends, R&D progress, and predicted revenues Where is the market for pain management devices [ https://www.visiongain.com/Report/1286/Pain-Management-Devices-Market-Forecast-2014-2024 ] heading? What are the commercial prospects for this market and related technologies? Visiongain [ https://www.visiongain.com ]'s new report shows you potential revenues and other trends to 2024, discussing data, opportunities and prospects.
Our 226 page report provides 175 tables, charts, and graphs. Discover the most lucrative areas in the industry and the future market prospects. Our new study lets you assess forecasted sales at world market, submarket and national level. You will see financial results, interviews, trends, opportunities and revenue predictions.
Forecasts from 2014-2024 and other analyses show you commercial prospects Besides revenue forecasting to 2024, our new study provides you with recent results, growth rates, and market shares. There you will find original analyses, with business outlooks and developments. Discover qualitative analyses (including SWOT and Porter's Five Forces Analysis), company profiles and commercial developments. Read the full transcripts of two exclusive expert opinion interviews from industry specialists informing your understanding and allowing you to assess prospects for investments and sales: - Dr. Deepak Kotak, Executive Vice President, BioElectronics Corporation - Ms Penney Cowan, Chief Executive Officer, The American Chronic Pain Association
You find prospects for key submarkets
In addition to analyses of the overall world market, you see revenue forecasting of seven world-level pain management devices submarkets by device-type to 2024: - Spinal cord stimulation market forecast 2014-2024 - Radiofrequency ablation market forecast 2014-2024 - Analgesia infusion pumps market forecast 2014-2024 - Microcurrent electrical neuromuscular stimulation market forecast 2014-2024 - Intradiscal electrothermal therapy market forecast 2014-2024 - Transcutaneous electrical nerve stimulation market forecast 2014-2024 - Others (includes patches) market forecast 2014-2024
Additionally, our new study provides revenue forecasting of six major pain management devices submarkets by application to 2024: - Neuropathic pain devices market forecast 2014-2024 - Cancer pain devices market forecast 2014-2024 - Surgical & trauma pain devices market forecast 2014-2024 - Musculoskeletal pain devices market forecast 2014-2024 - Migraine & facial pain devices market forecast 2014-2024 - Other applications (includes dental pain and obstetrical pain) pain devices market forecast 2014-2024
Technologies that improve on the tolerance and dependence issues associated with pain relieving drugs will achieve success. The increasing use of neurostimulatory devices, in particular, will be a major benefiting factor for the pain management devices market as a whole.
Our new investigation shows business research and analysis with individual revenue forecasts and discussions. You find dynamics of the industry and assess its potential sales, seeing technologies likely to achieve the most success.
To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com
What are the prospects for the leading regions and countries? In addition to analyses of the overall world market, you will discover individual revenue forecasts for 13 national pain management devices markets to 2024: - US - Japan - Germany - France - UK - Italy - Spain - Brazil - Russia - India - China - Mexico - South Korea - Rest of the World
Regulatory, demographic, and commercial developments worldwide will influence the market, both in the established North American and Western European economies, and the fast-rising emerging markets.
Leading companies and potential for market growth Our work forecasts the overall world revenue for pain management devices will reach $3,336.5m in 2014. We predict steady growth from 2014 to 2024. Our work shows you which organisations hold the greatest potential. See profiles of 10 leading companies, including these: - BioDelivery Sciences International - Boston Scientific - Cephalon (Teva Pharmaceuticals) - DJO Global (Empi Inc) - Endo Pharmaceuticals - Hospira - Kimberly-Clark Healthcare - Medtronic - Pain Management Inc - St Jude Medical
A company profile gives you the following information: - Overview of the company, including its history in the market - Recent financial results - Assessment of recent developments - mergers and acquisitions (M&A), new products, and collaborations, including alliances, partnerships and joint ventures - Discussion of a company's activities and outlook including description of
leading products
To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com
What issues will affect the pain management devices market? Our new report discusses issues and events affecting the pain management devices market. You will find discussions of many issues and developments, including: - Cost savings and efficiencies - Overcoming drug tolerance and dependence - Understanding pain pathways and mechanisms of action - Safety and patient compliance - Clinical evidence supporting product efficacy - Reimbursement and legislation
Our investigation gives you multi-level business research and analysis with sales forecasts. You see how that industry and market can perform from 2014 to 2024.
You will find quantitative and qualitative analyses with independent predictions. You receive information that only our report contains, staying informed with this invaluable business intelligence.
Information found nowhere else With our survey you are less likely to fall behind in knowledge or miss opportunities. See how you could benefit your research, analyses, and decisions. Also see how you can save time and receive recognition for commercial insight.
Visiongain's study is for everybody needing commercial analyses for the pain management devices market and leading companies. You will find data, trends and predictions. Please order our report now.
To request an exec summary of this report please email Sara Peerun at sara.peerun@visiongainglobal.com or call Tel: +44(0)20-7336-6100
Or click on https://www.visiongain.com/Report/1286/Pain-Management-Devices-Market-Forecast-2014-2024
Companies Listed in this Report
Abbot Laboratories
AcelRx Pharmaceuticals
Advanced Bionics Corporation
Advanced Neuromodulation Systems Inc
Atricure
B Braun Medical
Baxter International
BioDelivery Sciences International
BioElectronics Corporation
Biosense Webster Inc
Blackstone Capital Partners VLP
Boston Scientific
CareFusion
Cefaly Technology
Cephalon (Teva)
Cosman Medical
CTI Technologies
Current Solutions
Diros Technology
DJO Global
Endo Pharmaceuticals
eNeura Therapeutics
Fukuda Denshi
Grunenthal GMBH
Hong Qiangxing (Shenzhen) Electronics Limited
Hospira Intelect Medical (a Boston Scientific company)
Kimberly-Clark Healthcare
Kunwha Pharmaceutical Life Sciences Inc
Meda Pharmaceuticals
Medtronic
MicroTransponder Inc
Moog Inc
Neurometrix
Neuros Medical
Neurotech Group
Neurotherm
Nevro Corporation
Pain Management Technologies Inc
Philips Healthcare
Polyon Medical Corporation
Qrunenthal GMBH
Quintiles
ReAble Therapeutics Inc (JO Global)
Relievant Medsystems Inc
Smith & Nephew
Smith Medical
Spinal Modulation Inc
St Jude Medical
Stryker Corporation
TTY Biopharm,
Watson Pharmaceuticals
Organisations Mentioned In The Report
Case Western Reserve University
International Association for the Study of Pain (IASP)
Mayo Clinic, Arizona,
US Ministry of Health and Welfare (MOHW) [South Korea]
National Institute for Health and Care Excellence (NICE)
Samueli Institute for Information Biology, US
The American Pain Society The American Chronic Pain Association (ACPA)
The Centers for Medicare and Medicaid Services
The Centre for Devices and Radiological Health (CDRH) [FDA] The Food and Drug Administration
The International Diabetes Federation
The National Headache Foundation [US]
The National Institute for Population and Social Security Research (IPSS) [Japan]
The US Society for Neuroscience (SfN)
The World Health Organization (WHO)
University of Texas, Dallas
US Census Bureau
To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com
Copyright (C) 2014 PR Newswire Europe
Hi M:
Don't see a tab "News"
Would you please give me the link trail precisely?
thank you
Of course he has! Many times. And I know of a magnificent bridge in NYC I can let you have cheap, today only.
Don't know how this got past iHub's wonderful 'ignore' function, except that I am currently on a travel device.
I assume the trial data submissions you reference, which only require submission pursuant to Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), and which require only the submission of "basic results" for certain clinical trials have not been published because firstly, BIEL has a very substantial business position to protect, and secondly, such data is actually none of our business until management decides it may be, or not. BIEL is not funding and managing its various product trials for our pleasure; they are being conducted for the FDA regulatory processes.
"There is rarely, if ever, any advantage whatsoever to advising another of everything one knows. Never reveal one piece of confidential information without obtaining one before and one after in return."
A famous man in diplomatic circles once said that.
Nope, think you're correct penny - art was hustled by the fancy name - the Nat'l Center for Health Research used to be the Nat'l Research Center for Women and Families. Non-profit, non-whatever, sometimes such entities are non-everything. You were had art! Now I know why they changed their name - kching kching. I wonder if Diana Zuckerman even saw that letter sent to the FDA??? She's a pretty bright lady, but the letter seems off the mark in its bias.
What other "department" art?
Saw this before super, found it boring, very biased in favor of something, not sure what and not worthy of comment at the time. I did some back-channel research on their funding with respect to the pharmaceutical industry. Nat’l Center for Health Research used to be National Research Center for Women and Families. Name changes are always for a reason, sometimes reputation and dwindling effectiveness.
Paul Brown and Diana Zuckerman bios are self-evident and they appear to be very good and dedicated people. In my opinion, there is the odor of bias; the letter has the appearance of one of the staff assistants having been tasked with drafting a general counter-argument which was then edited and submitted to the FDA on the day comments closed. I suspect they write a letter to every forum going. The letter chops up previous comments and opinions of others eminently qualified in the science of PEMF/SWT but does not contain one iota of original thinking, the usual stance of such items. See comments below prefaced with (*** comment) if there appears only *** it means it could possibly be unclear, biased, innuendo, or totally lacking in facts or scientific evidence. For example, go to center4research.org and read. You will see the appearance of doing a lot of good, but there is no evidence. How can I say that? Because I just did. It may or may not be so, same for their letter, generally, it may or may not be so.
Paragraph 5
In contrast to the lack of evidence about effectiveness, (*** researched and shown? No) there is clear evidence that the product can harm patients.(*** what evidence?) In this 2014 proposed order, FDA has identified nine health risks associated with nonthermal SWT devices: cellular or tissue injury, electromagnetic interference, tissue necrosis and burns, electrical shock, thermal injury from implanted leads, adverse tissue reaction, adverse pregnancy outcome, risk to children (the device can affect the growth plates in children), and ineffective treatment.(***see coalition comments to FDA 2014 which make these innuendos phooey) These are very significant risks; (*** drama mongering?) MAUDE reports regarding these devices included blisters, third degree burns, shock sensations, and interference with a pacemaker.2 (***more drama but zero evidence of blisters, 3rd degree burns and electrical shocks. I seem to recall someone using a cream that burned their skin)
Paragraph 6
Unfortunately, none of the six studies industry cited systematically measured and recorded adverse events, thus providing no scientific evaluation on safety.(*** Because there weren't any) In addition, the studies were too small to appropriately measure adverse reactions, with only three of the six studies including at least participants and none with more than 100.(***Something missing in this sentence, but plenty of hysteria)
Paragraph 7
The FDA has stated that it “has been reviewing these devices for many years, and their risks are well known.” We disagree. (*** Oh, we disagree with the FDA but we offer up no reasons for doing so, always easy to sling arrows) A tiny percentage of adverse reactions are reported to the MAUDE database, making it impossible to know how frequently adverse reactions occur. (*** Sounds good - How about a tiny percentage of adverse reactions were reported because that's all there were - how can anyone state that it's impossible to know something negative if they don't know that such exists?)
Paragraph 8
Pain management is serious business. (***Fluffy and full of goodness) The FDA has approved several prescription drugs with clear risks of addiction. (*** This sentence has nothing to do with anything but dramatic setup for what followed) If the FDA is willing to clear unproven medical devices aimed at reducing pain rather than requiring evidence of effectiveness, the unintended consequence will be more prescriptions for pain medication, (***nonsensical assumption, but I’ll let that slide if the other side of the equation is that given the effective pain management of PEMF/SWT devices, it must hold therefor that there will be less prescriptions for pain management) including the drugs that have been proven to be most addictive. (***more drama because of the lack of facts and science)
Paragraph 9
We urge the FDA to keep nonthermal SWT devices as class III devices and require a PMA as FDA originally recommended in its 2012 proposed rule. (***We urge? Based on what? Because that suited the pharma industry sales and had nothing to do with anything else?) General and special controls cannot compensate for a lack of safety and effectiveness evidence. (***There is absolutely no evidence, scientific or otherwise of a lack of safety or efficacy, in fact, quite the contrary by my reading) Downgrading these devices to class II is not justified. (***Reckless and unsubstantiated statement and again serves the chemical and drug side, which the letter is also highly critical of, but not the growing devices side of the pharmaceutical industry) By requiring a PMA, companies would be required to prove that their products are safe and effective.
The good thing is that drugs, pain management and overdosing Americans will all take on the same smell as big tobacco denying culpability for decades and then blaming the smokers, while quietly divesting into other industries away from smoke to maintain profits and dividends for shareholders. Meanwhile, governments then and now survive and thrive to a large degree on tobacco taxes. The medical and hospital machinery remains highly profitable thanks to tobacco.
The letter seems to slam device manufacturers, pharmaceutical companies, the FDA, all research and findings and just about anyone else in its cross-hairs. How can any such group be so right, yet the rest of the world, us simpletons, are so wrong? Because they rely on donors, have no skin in the game and are very good at providing compelling rhetoric on most any subject under the guise of doing a lot of good and showing us the way. If I take the letter apart, I am at a loss to find anything that makes real sense backed up by anything but more rhetoric. Sorry for the length, you asked. At the end of the day, you judge if the letter makes sense or is simple bias.
Why is today any more important than tomorrow or yesterday in contributing to another month until news of the FDA creation of the new category? Please explain? Thanks
Hey 7up. Since such a strategy might involve slamming the company and potentially buying 100's of millions of shares, over the past 6 months, how do you think it might be funded?
Where does one begin?
Would appreciate clarification as to sources of statements implying factual bases and rationales for strong opinions:
1 what, no pump? When was the last pump?
2 what Reverse Split ("RS")?
3 who really care if shares go to 10Billion, still a peanuts market cap
4 who says no one will touch it?
5 who is saying "all the Andy won't RS"?
6 aren't they selling shares just fine to fund operations?
7 no one has filed as FDA is creating new Class II - that's a fact I'm donating
8 Source of fact "clinicals aren't there"? how is this known?
9 "File pay and get denied - is this fact or speculation?
10 "only 1K at 18 to move off the bottom again" Is this speculation of 18 cents? I like it!
11 It will drop more and more - crystal ball . . . . .
12 shares went up, twist and turn, twist and turn - getting dizzy and too tired to go on here
I like the post generally, as its' structure seems to accurately reflect the underlying calm and focused rational thinking of an organized, articulate and somewhat healthy intellect. Well done.
Terrific work yankee - please keep it coming. Your exhaustive research and contributions have helped to present the truthful picture of why the FDA issued its Proposed Order creating a new ClassII for BIEL's and other's devices and stated in that Proposed Order that the Agency was doing so 'on its own initiative" and "based on new information". These are facts that just can't be refuted or twisted.
Hey Stock - on what do you base your statement that BIEL is broke and can't wait for the FDA? Can you reveal your source or is this just your opinion? Thanks
M
I am humbled and almost at a loss for words reading your post. Thank you for rounding out the sense of purpose for me in contributing to the discourse on the BIEL story. I feel I may have been in the right place at the right time to assist you.
I did not have any idea of the sensitivity of these issues for you and your husband. If in some way I opened up scar tissue, please forgive me. If, on the other hand, I have been able to assuage your pain somewhat by helping the cause of managing pain more safely, that would be a greater accomplishment than the upcoming success of BIEL.
Hi M.
There is no doubt, in my mind, that the staff and managements of the FDA and CDC, as well as elected representatives and their staffs in DC, and the AMA, are all totally aware of the literal stranglehold our society has allowed chemical painkillers, both Rx and OTC, to have on our nation. Sad crisis.
And then, all it will take is for the media to cover a few deaths from Rx or OTC over-prescribing for the insurance industry to warn doctors of their liability for over-prescribing and increase liability premiums to cover what's coming. Then comes the legal profession, specifically litigators, to ramp it up on behalf of victim's families, then those who would defend the doctors and pharmaceutical companies and, lastly, tens of millions in legal fees. These have always been areas of litigation, but with the recent surge in awareness of what drugs are doing to Americans, these tsunamis may have already begun. PEMF/SWT makes more and more sense every day for logical and safe pain management. And that is why the FDA is getting on top of it. This stuff is new to the mass markets, but its' time has come.
Hey yankee - thanks for the link. You had me in the first paragraph - 70% of Americans on 1 Rx and 50% on AT LEAST 2? Things are indeed out of control!!!
QUOTE your link:
"A recent study, by the prestigious Mayo Clinic, revealed the alarming statistic that 7 of 10 (70%) of Americans are on at least one prescription drug; with more than 50% taking at least two. These researchers found painkillers to be the third most prescribed class of medication.
This study was limited to evaluating only the use of prescription medications and did not include the prevalence of over-the-counter (non-prescription) drugs taken for common aches and pains. Certainly, if we factored in the use of the popular “go to” non-prescription pain pills often taken for recurrent headaches, backaches, arthritis, menstrual cramps, etc.; it would not be a stretch to conclude that the use of painkillers is epidemic.
UNQUOTE
Since the process awaits FDA publishing Final Order, after publishing the Proposed Order on page 9671 of the Federal Register on February 20, 2014, here's the link ( http://www.gpo.gov/fdsys/pkg/FR-2014-02-20/pdf/2014-03594.pdf ); the FDA request for public comments that closed May 21, 2014; the completion of the FDA review of those comments June 20, 2014 . . . . . . Final Order?
I can't think of any reason, other than articulation of Special Controls in the Final Order, why there should be a long interval required to edit the Proposed Order into its Final Order format.
Therefor, new timing forecast for Stockin et al:
Somewhere between immediate and imminent.
Rather soon. You see?
Ask Stockin, he'll tell you.
Sorry guys, got a message and blank screen saying iHub was down for maintenance and that's why..... someone else's post were crashed too, fixed I guess, not soon enough :)
Rather soon. You see?
Points taken tj, very little is perfect, but to the large degree I believe FDA gets it right now. Don't forget PEMF/SWT was an emerging science in pain management at the FDA. BIEL's advantage is that it has shown it not only deals with the pain, but also promotes healing.
And I think you're right about 2009 in that BIEL didn't know much more than whether it was punched, bored, or scooped out with a spoon in FDA regulatory processes and had a crappy disposition when asked to produce more credible data. Different world today, Whelan has added professionals to the BIEL management team, members of which are obviously working well with staff at the FDA.
But, it's less soon than bloody soon. . . .
So, I think it will be soon; and I hope it will be rather soon.
On the other hand, it can't be soon enough!
tj, it is much more complex than you would like it to be.
FDA reviewed every word of every comment probably by 3 or more people with at least 2 science or engineering degrees in order to ensure that they did not miss even the tiniest new piece of information. Guaranteed!
Read the coalition comments behind the link I sent you. Only thing I can think of is that there will definitely have to be a Special Control in at least the areas of exterior package labeling, front and back, and prominently displayed on product information inserted into the packaging for any PEMF SWT device regarding restricted use by anyone with an implanted pacemaker.
Now, folks with pacemakers are well educated to stay away from certain appliances, tools and devices, etc., and anytime a patient is having a surgical procedure, forms ask and people ask about pacemakers, but what about the grandmother who arrives at your house and is so glad to see that your daughter is alive and thriving with her new pacemaker that she rushes to her and picks her up and gives her a big hug and a kiss, but isn't aware and hasn't told anyone that she is wearing an ActiPatch or some other device from one of the 4 other companies that prepared and submitted the coalition comments? And you don't have time to ask her if she's got any devices on board. Oooops. Grandma just completely inadvertently re-set your kid's heart rate!
So, it needs looking into a Special Control on the packaging and any product inserts or directions. Not a big deal, FDA deals with this stuff every day and ActiPatch around your granddaughter may well be a lot safer than the little envelope of 12 Tylenol 3's in Grandma's purse because she likes to travel with some and leave the kid-proof bottle at home. I'll bet on a Special Control for pacemakers for some devices, maybe not BIEL's because they are not very powerful, as say compared to our cell phones but the FDA must be certain. It's your granddaughter tj.
I respect your concerns about money and lobbyists, matter of fact I share them, but I totally disagree with your cynicism regarding FDA management and staff. I've met a few and worked with a few and found them to be very bright and dedicated to excellence in what they do. Are there bad apples? Everywhere in life, but not enough at the FDA for me to share your cynicism. I do notice that many problems are caused concerning approved drugs through abuse, over-prescribing, off-label and a thousand other ways. Seen many people take their prescribed medications and wash 'em down with a drink at lunch and after work! FDA didn't approve that, but people do it.