Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
You're right - there seems to be an agenda based on anger and failure of a little company with great and much needed products in a market space rampant with deadly side-effects. I too ask why?
Also, why a tome written to describe simple math? 350 million shares 2 years ago and 3.5 billion shares now-so what? When BIEL went from .0040 to 12 cents on no news, no FDA and no progress, it is conceivable it could have gone to more than a buck if those things had become reality instead of hopes, a business success. Now, there is Gro-International, Health Canada approval, zero side-effects, strong possibility of FDA approval and a larger product line, like ALLAY, for drug-free relief of monthly menstrual cramping, every month, every year!
Is it not therefor possible that share price will rise to between 10 and 25 cents? Of course it is, in which case folks make a ton of money. .0018 cents to a quarter? Is someone kidding? At a dime I'm laughing, at a quarter, I just retired!
Agree with you again 10 - the possible 'promoter' may well be a broker type or Gro-International - who better to hold shares with which to capitalize on marketing successes? Who wins? We do.
BIEL went from .0040 to north of 12 cents on absolutely nothing a couple of years ago other than a "hope" for FDA approval. Since then, the product line is dramatically expanded, not out of the FDA game yet, science has improved, device applications (a relatively new category at FDA) are up, so forgive the cheerleading, but why wouldn't the price rise?
Of course this is dilution, but that is a label. The issues are why and why now and therein lie the interesting possible reasons?
I know there are probably double the shares out now, and Whelan has financed the operatiuon through dilution, but if Gro-International is successful and the FDA gets it together, why not 4 cents? Or 40 cents?
The one thing I know is no one knows for sure, especially the cynics and bashers. Would I be very happy at 25 cents? You bet! I was happy before when I sold at between 7 and 8 cents on nothing! No sales, fewer products, no FDA, no Gro-International, no Health Canada approval, zip! Patience is the name of this game as was wisely posted by another.
Thanks fuente - good luck to you too.
There is a third possibility, which I have articulated a few times, but I think its best to say no more, other than if I am Gro-International I want a very large share position in BIEL.
And, I think that is what is happening - I have only a few million shares, bought at higher prices - am I going to liquidate? No. So, who is going to liquidate 100 million shares? Who can liquidate 100 million shares? To me, it's obvious.
Cheers
Thank you Ten4 - I had this thought last Tursday as soon as I saw the volume shoot up as soon as the news came out about the Gro-International deal and have posted a few times about it.
When I see that a former fairly senior executive with P&G (25 year career) has made a deal with BIEL, that speaks volumes to this pinhead. And I then speculate that wouldn't it be smart for that executive, now having the confidence of Whelan, to forge a deal for the USA between BIEL and P&G management? This is not rocket science, it's how deals are done.
Needless to say, I agree with you and would love BIEL to start making good deals and producing and for the share price ro rise dramatically.
Couldn't agree with you more 3 pointer - I have patience, I know from personal use that ActiPatch really works well, no negative side-effects, ever and not a chemical drug.I think these are positive points.
I am an investor who hopes the share price rises, so I fail to see how my comments make me a paid stooge of BIEL or a lunatic.
BIEL just did a deal with Gro-International, Paul Kopick responded to fuente questions with a lot of clarity, RecoveryRx already has FDA approval, or are these all lies? They seem to be positive points.
I am also at a loss as to why others would fill the air with negative rhetoric. With all the above, is it wrong to think something is up? And does it have to be speculatively labeled as dilution, meaning Whelan is selling 100 million shares to get $180,000? I assume this is chicken feed compared to what he has invested in this company. So, I am at a loss as to why he would do this.
Ooops, almost forgot, I just find trading of almost 100 million shares in less than 4 days of trading an anomaly, or am I incorrect there too.
Neither - But just a simple question mad - if, that is, if, Gro-International wished to acquire 100 million shares at cheap prices, how would it do that?
Thanks
Hey kid and fuente - I think we are on the same page here......
Given Gro-International plus BIEL nomination for OTC new product of whatever in the UK award plus now more than 75 million shares traded in less than 3 full days of trading, is it not possible that an entity is buying stock at a great price from a willing seller to establish a position for the upcoming growth of BIEL?
I know -that's why it seems like a way for someone to get skin in the game - great!
I'm glad I had rare time today to watch this. Volume now over 20 million at noon. I think that is north of 50 million shares traded since the opening last Thursday, the day of the Gro-International press release?
Does anyone know the last dates that BIEL traded north of 50 million shares in 2.5 trading sessions?
Gro-International - see iHub posts last Thursday 28107, marketing deal for BIEL with this firm headed by ex-executive with P&G - suggest you read up on it, the announcement was just before the start of higher volumes over the last 3 days -seems to some people that something is up. Find the post, I think by fuente's good work, which contained answers by the BIEL PR guy last week, then come forward.
Seems to me that some entity, company or individual, has purchased 50 million shares, plus/minus, last Thursday, Friday and today. Many more shares than BIEL may have traditionally sold each month to keep things going. If Gro-International was the buyer, either to put skin in the game or to give BIEL funds for marketing, hooray! Good luck to whomever the buyer was if BIEL goes to $ .25 - would we not be happy with that?
imrich - are you suggesting that BIEL should or could move up to the NASDAQ OTC Bulletin Board if the price goes north of a cent, like 5 to 10 cents or so? Might the sale of 50 million shares be enough to help fund such a move off the Pinks? I have no idea what that might cost, do you have any knowledge that would help me understand? thanks
Because buyers are taking advantage of the price opportunity!
I think the Gro-International deal and common sense, along with BIEL management getting out of its own way in markets it has no experience in are working. If all this works along with no side-effects, ever, and solid efficacy, we may be on a positive move here. 13million shares traded and it's 10:40? On top of 36 million lat Thursday and Friday? I'm still confident on my theory that the new boys are buying stock with the blessing of the market and solidifying their opportunity for huge upside with marketing success. Go BIEL
Suggest you read Bio of Gregor Forbes, and his 25 year career with P&G - please see my post #28117 - hope it helps.
Also seems logical to me that if Gregor Forbes after a 25 year career with P&G, much of it at the executive levels portrayed in his bio, parted ways or retired without any burned bridges,would he not be instrumental in helping to initiate and develop a relationship between BIEL and P&G for the USA market?
It also seems to me that BIEL management is finally starting to see that having a smaller piece of a bigger pie is wise. When Whelan had it all, shares, control and limelight, BIEL went nowhere fast! By involving others, better qualified and perhaps more powerful, maybe this thing can grow. It is a successful product line waiting for management to catch up IMO.
I'm sure everyone appreciates your tenacity in communicating with Paul Fuj
From your post - Paul's response, I've highlighted in X's below some points I find very interesting and my comments......
Just received this from Paul:
Greenwood’s market is the US. They work with Ceuta International outside of the US. Ceuta is exceptionally good but outside of our price range. Gro-International works with Ceuta and Greenwood, XXXbut has given us a good fee, mostly contingent on performance. XXX (It seems to me that the deal with Gro-International may allow them to profit from S/p upside, thus they were 'allowed in' to pick up over 36 million shares at bargain prices on Feb 14 and 15.)
We still plan to use Greenwood in the US. XXX Most Canadian product launches occur after the products are established in the US.XXX (
The naiveté and stubbornness of Mr. Whelan caused him to go to Canada in a huff to show up the FDA for its delay of BIEL's approval here - bad boy - he did not realize, probably through inexperience, as everyone in the pharma industry knows, that Canada does indeed follow the USA, except in matters of regulatory approval. I'm advised Health Canada is competent and less tied up in bureaucracy, thus their faster assessments and approvals or rejections, but the retailers still ask, 'has the FDA approved this?"
The clearance issues on Allay and ActiPatch are exactly the same. The clearance denials are incomprehensible, XXXwe are still ongoing discussions at the FDA’s Office of Science Integrity.XXX
(Huge - the discussions continue, obviously behind closed doors, exactly where they should be taking place)
XXXIt is very difficult to negotiate with the FDA in a public arena.XXX
(This seems magical to me - The FDA should never be put in such a position as negotiating or having scientific explaining take place in public! It tells me that there may be discussions or negotiating taking place privately, which is appropriate. As I posted a year or more ago - this may still be about saving face. An applicant never gets approval by embarrassing an approving body!)
Appeals on 510k’s 091817 and 092931, ActiPatch and Allay are predicted on classification IMJ not the “non-thermal” ILX code. We are not petitioning for a non-thermal classification, it is this misclassification we are appealing. It is our assertion that over 30 years of research has produced no convincing evidence of any non-thermal effects with RF therapy.
XXXIt is now the scientific community’s widely held consensus and the Agency’s that there are no physiological effects from shortwave RF therapy that are not thermally related; that is, there are no non-thermal effects of RF exposure.XXX
(Fuj - if this is absolutely accurate, we may be in business and you should get to Paul and tell him to button up - I can only assume he was trying to be helpful to you, but no one should be stating another's position at this point, things may be too delicate)
I also like Kingsransome's post #28172 about 5 cents without a r/s. My take is that if BIEL went north of 12 cents a few years ago on hype, where will it go on FDA approval?
Cheers
Nope - seems to me that Gro-International may have wanted shares and perhaps Whelan is selling into that?
Mr. Forbes clearly knows what he is doing - BIEL would be foolish not to have given him a free hand in developing market share for the entire product line. If Forbes and his team have millions of shares? Better still!
Sooo, the facts are - it seems to me we have a product line which generates zero negative side-effects, has regulatory approval in many countries, proven efficacy (used ActiPatch on a badly sprained ankle and reviewed by my doc to his total amazement)and not a drug!
With Forbes, with his proven experience at P&G, plus a winning team at the helm of marketing, what is our downside?
Found this bio and pasted it in as is - quite a career.......
Berufserfahrung von Gregor Forbes
Manging Director/Joint owner
Gro-International SARL
February 2012 – Present (1 year 1 month) Switzerland
Gro-International is a full service distribution operation focused on building brands with mid sized companies in Africa , Middle East and Eastern Europe. Gro-International is headquartered in Geneva with a network of partners in core countries.
Owner
Acorns2Oaks International SARL
April 2010 – Present (2 years 11 months)
Acorns2Oaks is a independent consultancy that focuses on providing strategic and executional support for FMCG brand owners who seek to build their International foot print. Services include brand and market assesments, licenisng and acquisition targets as well as distributor / organisational capability. Acorns2 Oaks has a network of consultants in Eastern Europe, Africa, Asia and Western Europe.
Interim CEO Chemi & Cotex Industries
ChemiCotex East Africa
May 2011 – July 2012 (1 year 3 months) Dar Es Salaam - Tanzania
General manger- Global Development Markets
Procter & Gamble
Public Company; 10,001+ employees; PG; Konsumgüter industry
June 2009 – October 2010 (1 year 5 months)
Manager of the Global Development markets organization with P&G. New structure established to grow small/new markets and manage small brands via distributors and in market agencies. Based in Geneva but with teams in key P&G global locations.
Responsible for setting overall organization strategies, brand plans, go to market execution and organization development. Externally involves managing the interfaces with distributors and consumer agencies to build market share.
Non Executive Board Member
Swiss Precision Diagnostics
April 2008 – September 2010 (2 years 6 months)
One of 6 Board members on Swiss Precision Diagnostics a joint venture between P&G and Inverness Medical of Boston. Clear Blue pregnancy and ovulation kits the key brands.
Board provided direction to management team on innovation, compliance, international expansion, acquisition targets and consumer marketing/customer management
Director Development & Export Markets - CEEMEA
Procter & Gamble
Public Company; 10,001+ employees; PG; Konsumgüter industry
September 2003 – May 2009 (5 years 9 months)
Building P&G brands in expansion markets predominately in Middle East and Africa as well as running speciality brands (Pringles, Vicks etc) in key Central European and Middle Eastern markets.
Managed a multi-functional team of 100 P&G managers and the direct interface with 70 distributors and 30 in market agencies.
Revamped business from a side line within P&G to a strategic to to market alternative which became base for a global business model.
Associate Director - Commercial Products CEEMEA
procter & gamble
Public Company; 10,001+ employees; PG; Konsumgüter industry
2000 – 2003 (3 years)
Developed from scratch a business across 20 countries in Middle East and Africa for P&G commercial cleaning products. B2B selling via distributors/specialist to HORECA, Government tenders, Institutional Cleaning/Hygiene companies.
Led a team of 20 Sales , Customer service and Brand managers
Sales Manager - Laundry/Personal Cleansing/Oral Care Greater China
Procter & Gamble
Public Company; 10,001+ employees; PG; Konsumgüter industry
November 1997 – January 2000 (2 years 3 months)
Responsible to ensure key Sales and Customer needs incorporated into the business plans for Laundry, Oral Care and Bar Soaps. Worked within the three business teams with a small group of project managers
Market Development Manager - Ukraine
Procter & Gamble
Public Company; 10,001+ employees; PG; Konsumgüter industry
March 1995 – November 1997 (2 years 9 months)
First P&G manager to live full time in Kiev. Responsible for establishing company in the Ukraine from office infrastructure, through recruitment of local sales, customer service, marketing, finance and HR and establishing a distribution infrastructure across Ukraine. Latter involved finding local Ukrainian entrepreneurs to establish regional distributor companies. Today these same companies for back-bone of P&G go to market in Ukraine.
Various sales and marketing positions in P&G UK
Procter & Gamble
Public Company; 10,001+ employees; PG; Konsumgüter industry
November 1984 – March 1995 (10 years 5 months)
3 years in Foodservice sales (fats&oils) before moving into Marketing for Industrial Foods UK and then in 1990 for Continental Europe.
From 1993 to 1995 led the Customer Marketing and Customer service operations for P&G Professional Europe as well as responsibility for JV in commercial laundry.
Agree with you Dubb - one of my ActiPatch packs states quote: Do not use if you are pregnant or if you have an implanted medical device. For Adult use only. See product insert for more information.
As I described in a post a few days, ago and as you have wisely posted, FDA must not approve for any application, never mind BIEL for OTC approval without first scientifically confirming efficacy and safety without bias, by its in-house or consultative staff, all without influence pro and con by members of the public with agendas. It's a price we pay for involvement in a new treatment space and product line - PEMF devices and BIEL. The pros at FDA will 'get it' - remember the people who said that the horse and buggy were here to stay? The harness makers! I have faith in the FDA and BIEL - zero side-effects ever and solid efficacy.
Hey Casper - your last 2 posts - including 28046 - say tons - hopefully logic will prevail - the FDA could not have had any scientists on board who were 'experts' in BIEL's products - let's face it, BIEL didn't know how to present what it had to the FDA!
I am confident the FDA has or is putting people in place who truly 'get it' in the device space. The future is here and if it can be drug free, then the FDA has legal obligations - I am confident they will do the right thing, too may eyes are watching. The support of what you and I are saying is that the FDA has a whole product space suspended awaiting assessment and approval. What's to stop it - BIEL is selling efficacy with zero side-effects at reasonable prices! Who can stop it?
I am a great admirer of tenacity and that may be what is going on as well
Hey fuente.....
Check out Health Canada process at the two sites below - one official. Read somewhere they have a max of 180 days to say aye or nay and are averaging 130 days.
BIEL - no negative side-effects ever!!! No wonder we're in deep doodoo in this country at so may levels - it's discouraging.
http://www.health.gov.on.ca/en/public/programs/drugs/approval/approval_health.aspx
and
http://www.marsdd.com/dms/entrepreneurtoolkit/Regulatory-PDFs/How_New_Drugs_Are_Approved_in_Canada.pdf
NOC: Notice of Compliance
NOD: Notice of Deficiency—sponsor has 90 days to respond
NON: Notice of Non-compliance—sponsor has 90 days to respond
NOD/w: Notice of Deficiency/withdrawal letter
NON/w: Notice of Non-compliance/withdrawal letter
SDN: Screening Deficiency Notice—sponsor has 45 days to respond
SRL: Screening Rejection Letter
NOC/c : Notice of Compliance–with Conditions
Clarifax—can be issued at any point during review, and sponsor has 15 days to respond
Seems to me the price may start to move in the next few weeks in anticipation of the FDA meeting on approvals as an OTC product on April 5th.
Would this not be logical?
Hey Sausage - hope you're well.
If indeed the CEO's sister is the global distributor, I guess common sense says there should be total transparency as to BIEL's costs, selling prices to the sister's company, wondering if it is a private company, and selling prices to her international distributors.
The simple question must be asked as to why have such a potentially conflicted or messy setup? I am not accusing anyone of anything, it is simply intelligent and good governance and oversight of a publicly traded company to avoid trouble through clarity. Disclosure is the best remedy so as to avoid close scrutiny by the auditors, SEC, IRS or law enforcement.
And if there is one moment of hesitation about full and open disclosure, that would speak volumes.
I am sure the management of BIEL could not be so stupid as to divert revenue and income away from the public company to a family-member owned and therefor possibly conflicted private entity, to possibly avoid disclosure of income or taxes through diversion of profits off-shore in such games, but the company has the money of public investors and transparency therefor rules. In addition, the company has been financially supported by funds provided by the taxpayers of Maryland. I am just wondering, why go through such gyrations? What is the purpose? Thoughts?
Hey Steve - when you mention all the countries that have issued OTC regulatory approval for BIEL's product line, like Health Canada and in the UK, please don't forget the FDA here at home. The FDA has approved BIEL's 'RecoveryRx' product as a healing accelerator device for post-op opthalmic sugery patients, when prescribed, with remarkable results. Imagine that!
But, now, I choose to completely ignore the almost OCD naysayers and stick solely with the facts of BIEL products.
Fact - ActiPatch really works well - I know first-hand because I used it on a serious injury and my doctor could not believe the results;
Fact - it is financially affordable;
Fact - it is not a drug no chemicals rampant with side-effects;
Fact - there has never been one, not one, negative side-effect, imagine a BIEL TV slot - "sorry no negative side-effects";
Fact - we, along with BIEL management, must be patient, success takes time;
Fact - BIEL's management could have done several things differently, but we don't know anything about the decisions they faced and why, so we should have no comment now about the past;
Fact - the FDA didn't get it right first time either, it's new, and the FDA is now re-assessing all PEMF devices;
Fact - many very, very bright, articulate scientists have put their knowledge and wisdom forward in support of BIEL and other firms; and
Fact - I have said all this before, as have many posters here, and not one naysayer has refuted one word of the facts.
Wish I had known this before I got my wings clipped here. I always thought that commenting, even if critically, on the inappropriate thoughts and expressions of others, especially if they are inaccurate, outrageous and demeaning of third parties, was okay. But I also understand, now, that calling someone for calling someone else a "crook" is the victim's problem and does not warrant a response from me. Sort of like walking past a defenseless person being beaten and rationalizing that it is not my problem....... I was unaware that it was chewing up time and space on a board by calling the egregious, often libellous behavior. But then, I had also not read the rules either, I have always relied on common sense and fair play and it has usually worked. But now I have and understand it does no good to respond to idiots, so I have learned my lesson and now only post very occasionally, when I am allowed to.
I'm crossing my fingers and hoping the price stays down here until I can get back in after taking the loss for tax year 2012. April is not that far off and I would hate to pay a lot to replace the shares I sold.
I see no reason why BIEL will not get FDA approval. It works extremely well; I can only speak to ActiPatch having used it for a few weeks on a badly sprained ankle, but I see numerous other testimonials for other products in the line. I have not seen one word or piece of evidence of any adverse side-effects.
Hey I'm Rich:
To expand on Jimzin's rationale,
If BIEL was to accept FDA designations of Class III on all its' products and pay Sales Reps generous commissions on sales generated by Rx's written by doctors, would they not be further ahead by this proactive approach while the FDA sorts out Class II versus Class III approvals for such safe devices?
At the moment there are no FDA approvals for anything BIEL except the Recovery Rx eye indication, so there is nothing but inertia in the US. We are the hub of pharma comedy - State of Maryland issues a financial grant so BIEL can develop sales in other countries, while FDA ponders such for 2 or 3 years? Wait....what?
Speaking of other countries, what are sales in Canada, web-based and otherwise, where the Health Canada approvals for OTC sales are in place?
I am totally convinced that Class III in the U.S. and developing Class II OTC sales in Canada and the UK for the next 12 months satisies all 3 categories - puts cash flow and value into the company through increased share price - makes every shareholder including the Whelans winners - and leads to better lives.
Season's Greetings and a prosperous and healthy 13 everyone - GO BIEL! Drug Free, Side-effect free pain relief! Go FDA!
all points are very interesting in terms of the undertone Casper the ghost mentioned he senses.
My take is that the 3 groups - employees and mananagement at the FDA, political and the middle and senior executives at Big Pharma are not involved in the crimes alluded to simply because if it were true it would become public and who would want to go to jail?
Nope, I stick with a combination of BIEL and others not stating their case perfectly clearly inititally, thereby making it easier for the FDA to 'get it'. FDA seems to be on a better path, so patience will prevail.
Meanwhile, patented product line, zero side-effects, drug-free pain management, only a matter of time.
Question for you and other good guys Steve.
If you are right that essentially we are at another starting point, what if a Big Pharma CEO learned of BIEL's devices and mandated a group of his people to do some DD on BIEL?
They would learn that there are no side-effects whatsoever, that BIEL is in the process fo attempting to get FDA approval for OTC sales, that the FDA is in a quandary about BIEL, that there is a chance for approval and drug=free pain management and the stock is cheap.
That said, who has been buying hundreds of millions of shares the last year or so, or is it just MM's in and out to catch a few bucks. If I am top dog at J&J, who was director of their devices division, is it not cheaper to quietly issue a directive to buy shares along the way?
Hey Fuente
I believe you are correct but I also think the place we are at as investors is potentially a very good one.
There are numerous companies and devices in limbo at the FDA for re-classification, or not.
Obviously the FDA is addressing a number of issues at great cost and passage of time. They would not be doing so without a professional desire to receive submissions, listen to input and get it right
The device space BIEL is in was clearly muddled before, so clarity will be a good thing for that space, and hopefully for BIEL.
Having said all that, is it not a good thing to have BIEL alive and in the running for re-classification coming out of the April meeting?
I think it bodes well for the company and the share price.
Bottom line is the products work very well, zero side-effects and they will help people manage pain, drug free. No downside as I see it.
Guess the news is official now.
CNN half an hour ago:
Dr. Sanjay Gupta interviewing Bill Clinton in advance of a Sunday 8PM Eastern CNN show titled "Deadly Dose".
Dr. Gupta advised viewers that the US is in the grip of a deadly epidemic of Rx painkiller drugs. It was stated that 80% of the globe's painkillers are consumed in the US.
He went on to say that the US consumes enough Rx painkillers annually to provide every man, woman and child in the US one painkiller pill every 4 hours for 3 weeks. Hello!!!
And we own part of a tiny, little, under-financed Maryland company named BioElectronics which has a line of patented electronic painkillers before the FDA for OTC approval for a host of maladies, which has been approved in dozens of countries, including by Health Canada and the United Kingdom, with never one negative side-effect, ever, and the FDA is not approving it instantly, for what scientific reason?
On the basis of 3 levels of familiarity, I cannot reach out to either Dr. Gupta, or Bill Clinton, or any executive at CNN - can anyone else? This proves the nonsense people!
Think this message got lost in the flurry of posts the other day......
And I appreciate your opinion Rocker.
Seems to me that Whelan has been doing exactly what you wrote - the dilute and advertise plan - but minimally, to pay his bills and keep the company going.
He could have raised a lot more money had he sold hundreds of millions of shares at .0040 to .0050 and could have cashed out a couple of years ago at 12 cents, but why didn't he? I think it's because he wants this thing to succeed and cash out big time further down the road.
No question manipulating brokers could easily run this stock up several times to 25 cents, or more, on no activity and without the FDA releasing a favorable decision for OTC sales of BIEL products. They could do it virtually on a whim just to make money - stocks like BIEL run up and down in many markets.
But that is not happening. So I have to aks why? Because in my opinion, Whelan and the company are surviving just fine, paying the bills, while signing up distributors, by selling stock at these prices in anticipation of the bigger score down the road - 25 cents or far better, when BIEL does get FDA approval. Makes sense to me, otherwise why bother? He and his family own enough stock to make millions at these levels! Imagine the upside at 25 cents or half a buck? I'd be waiting too.
And I appreciate your opinion Rocker.
Seems to me that Whelan has been doing exactly what you wrote - the dilute and advertise plan - but minimally, to pay his bills and keep the company going.
He could have raised a lot more money had he sold hundreds of millions of shares at .0040 to .0050 and could have cashed out a couple of years ago at 12 cents, but why didn't he? I think it's because he wants this thing to succeed and cash out big time further down the road.
No question manipulating brokers could easily run this stock up several times to 25 cents, or more, on no activity and without the FDA releasing a favorable decision for OTC sales of BIEL products. They could do it virtually on a whim just to make money - stocks like BIEL run up and down in many markets.
But that is not happening. So I have to aks why? Because in my opinion, Whelan and the company are surviving just fine, paying the bills, while signing up distributors, by selling stock at these prices in anticipation of the bigger score down the road - 25 cents or far better, when BIEL does get FDA approval. Makes sense to me, otherwise why bother? He and his family own enough stock to make millions at these levels! Imagine the upside at 25 cents or half a buck? I'd be waiting too.
Just following your and hooker's trains of thought Steve:
Is it not more appropriate that BIEL engage several professional athletes to help market product rather than no one? I suggested many months ago sending free ActiPatches to pro teams and follow-up. Zero.
I suggested the incredibly stupid thought of having a woman market on behalf of the product ALLAY, for menstrual pain and cramping. Imagine, a woman speaking about a women's product! How unique would that be?
And the amazing idea, never thought of before, of making deals with the marketing spokespersons giving them a percentage of the uptick in sales and/or profits. Isn't that amazing? The concept of revenue and profits?
My sense is that unless Andrew Whelan thinks of it, an idea has no merit.....how can this be?
And you're right hooker, I can understand him when he is speaking, but it should be much easier than what I have experienced. He seems very intelligent and knows his company and its products backwards, but he is not a professional spokesperson, thus making him a sufferer of 'Founders Syndrome'. Look it up Mr. Whelan and do the right thing for yourself and your family, who have clearly bet the farm on BIEL.
Hi Finishgreen - at the risk of appearing verbose, would you please add a word or two either side of Tuesday's date, so this simple fool might understand your message? Thanks
Way to go Fuj - Mr. Brown's message actually provides great ammo to make it for easier for the folks at the FDA to grant BIEL approvals across the board - all products!
I have read up to 27112 and here is my feedback as you have requested.
Mr. Brown shoots himself in the foot (needs ActiPatch) and if I were you I would not write to him. Suggest you write instead to the FDA, since Brown's letter was addressed to you. If you write to Brown, you cannot win as he will only manipulate whatever you say to his own ends, which are continuing to be paid and feeding his amateurism as a self-appointed watchdog for the FDA. What? I wager this man is a huge thorn in the side of the FDA.
The Evidence:
"Members of the Coalition strongly support"? Scientific evidence?
"We strongly oppose the petitions"? No scientific evidence!
"Adverse events.......confirm the panel's concerns.....blisters, third degree burns, shock sensations, interference with a pacemaker" no scientific evidence, reckless, manipulative rhetoric! It gets better as he tightens the noose on himself.
“We agree with the FDA that they are Class III devices because they can have serious adverse health consequences, such as third degree burns or shocks to patients with pacemakers or implanted”. On what basis does Mr. Brown qualify himself to agree with the FDA on anything, particularly given that the FDA is wisely assessing the whole category? Mr. Brown is unqualified scientifically and without the clinical data the FDA has to agree or disagree with anything.
“We appreciate BioElectronics sending us data on their device. We were glad to see that the device had clinical data, but the number of patients evaluated is very small, and therefore can’t provide conclusive evidence of safety for most patients likely to use this device.”
Why can’t it be conclusive and who is Mr. Brown to determine what conclusive is? Mr. Brown comes a long way toward agreeing with BIEL, but of course he cannot go all the way to agreeing because that would conflict with his platform and mission, which is to dissent.
Brown goes on - “Even if BioElectronics had more conclusive data for its devices, that would not justify down-classifying an entire category of devices from Class III to Class II (moderate risk), because other devices in that category need to be proven safe and effective as well.“
So, he shoots himself in three additional ways. He does not have any problem with BIEL’s scientific data except with its quantity, which does not defeat or negate its credibility at all. Two, BIEL’s status as an individual product line has nothing to do with Brown’s nonsensical statement – “that would not justify down-classifying an entire category of devices from Class III to Class II (moderate risk), Three, BIEL products have nothing to do with other devices. Each product is assessed on its own merits. If BIEL products are different as suggested by iHub contributors, the FDA will indeed create a standalone category for them.
Brown’s last paragraph combined with his title and role as Government Relations Manager of the Cancer Treatment & Prevention Fund makes history – thereby placing his entire message in the proper round file – he’s a PR guy – how can he possible make the gigantic and impossible scientific leap from PR guy for the Cancer Prevention & Treatment Fund to scientific peer group commenter on BIEL PEMF therapy? He can’t and thus the reason why his message is nonsensical. The folks at FDA are very bright and will see through this guy’s complete and total blah blah in a nano-second. It’s about science and he said nothing about that.
Do the BIEL products work? Are they harmful? No. Is there one iota of evidence indicating one negative side-effect? No. I suggest Mr. Brown should stick to cancer, if he is qualified, and stop wasting the money his contributors have donated on matters about which he knows nothing. How about, oh, let’s see, commenting on the many atrocious side-effects of Temodal (Temozolomide) or Tarceva (Erlotinib) which are both prescribed in the treatment of astrocytoma, brain metastases from solid tumors, glioblastoma multiforme and melanoma, all of which are instantly understood by FDA personnel in the cancer treatment field. Stick to your field Mr. Brown.
Don’t write to him Fuj, he will only defend his blah blah statements with more blah blah statements and he has the time and other people’s money to do it forever. If it weren’t so repugnant, it would be laughable.
Seems to me that the common sense of elapsed time has long passed.
The FDA turned down BIEL's applicatiosn for OTC sales capability in the USA for ALLAY and ActiPatch.
BIEL rightfully appealed and thereafter Senators, consumers, shareholders, all waded in.
The FDA hosted a twenty or so FDA employee ALLAY meeting with BIEL, I think, on June 8 2012.
Now, if the FDA decision prior to June 8 to deny approval on ALLAY had merit, does it not make sense that they would have simply gone to their files and released the specific reasons for the denial? Yes, unless BIEL introduced new truthful and accurate data.
Did BIEL not have another meeting with FDA people on the ActiPatch denial? Are the two applications not in the same limbo status of review?
Clearly BIEL followed the correct appeal process and the FDA is following its correct review protocol.
The FDA has not released specific, correct and therfor acceptable data to support its earlier denials. There are numerous other products/devices caught in the same mess. Indeed, nthere may be other devices which cause concerns. To my knowledge, there is no record of one adverse side effect of a BIEL product and RecoveryRx is already FDA approved for post-op opthalmic use by prescription.
By simple logic, I say something good is in the wind since no one, not the FDA, ex-employees, disgruntled shareholders, dissenting orgs, no one, has produced one reason why BIEL should not receive approvals, or such reasons would have been produced long ago. I know some of this is repetitive, but as time goes by, is the logic nt more sound? There is just nothing negative published about BIEL products leaving me to wonder how approval could possibly be denied. On what basis could the FDA produce a denial if they were incorrect first time?
Good post TJ, thanks
Seems the 8 'supposed' posters are seditious collaborators, the worst kind of treachery. The folks at the FDA are too smart to be duped by such foolish letters. The only concern, if one were paranoid, would be that someone at FDA put someone in the author group up to it, which would be a criminal offence. On balance, no one is that stupid and FDA management will discredit the content of the letter as rubbish.
The point is, BIEL products work well, they are safe, and they replace drugs which scream potentially harmful side effects.
The proof of the safety of BIEL products with respect to burning patients, hot wires, unprotected leads, and so on, is that Recovery Rx is approved by the FDA for post-op eye treatment with no mention of the nonsensical electrical problems alluded to in the silly letter. Need there be further discussion? Products work, they are cost-efficient and safe and are not drugs!
A method I use in my lab when doing the conversion mentally
C X2, less 10%, +32 = F
e.g. 20C X2 = 40, less 10% or 4 =36, +32 = 68
As Robert de Niro said in the movie Dubb10 - "you're good, you're very good"
In my opinion, this is exactly how the FDA has tried to save face.
Look at the timing - the large 20 person plus meeting with BIEL management and bio-physicist was June 8th was it not? So, one month later FDA publishes this? It establishes a set of guidelines - rules if you like, under the heading "Additional Requirements" and declares costs per trial participant? Is this course change in mid-stream a by-product of the clarification meeting with BIEL? If it tightens the process for the sake of safety, fine. If it impinges on BIEL, not fair. C'mon, this is face saving and parental 'here's how you do it' stuff. I hope the FDA has thanked BIEL for the clarification. This is more than coincidental folks.
The issue now is where does BIEL stand opposite the new 'Additional Requirements' of July 9. Should BIEL management bill FDA for assisting in the establishment of regulatory protocols on a product line FDA is unfamiliar with - a guinea pig fee? Life does not work that way.
I see this as good news that the FDA is in the game. Again, well done Dubb10 - thank you!
Greetings Sausage - you have posted about this before and all the good guys have I think agreed that BIEL management needs to allow the FDA to save face and remain with dignity intact over the mishandling of the apps - who cares who is at fault - give the FDA in the upcoming meeting that latitude to be able to say that the company has now provided all the necessary data to allow the FDA to carefully assess the product and approve it for OTC marketing etc., etc., etc.
It never does any good in political forums to point fingers and blame others....
I see the late August meeting as only pertaining to ActiPatch - separate from the June 8 meeting which was only on the ALLAY application. Find the diplomatic solution people - allow the FDA to approve, while saving face - everyone wins!