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Hey Steve - sorry, ran out of time, wanted to check something.
I've read all the post since your well justified "rant" and to your copnfession that you are a gambler, as we all are when investing in publcly traded companies, please allow me to pose a casino analogy.
No dealer will ever say more than "welcome" or "good luck" when you sit down or "thanks' when you tip. They will never say, "you'll be a winner soon" or, "in a few weeks' or, "next hand" or "any day now" - they would be immediately canned.
Whoever told you and/or other investors these fables did you all a disservice. I am a businessman. Had I been CEO of BIEL, I would have muzzled all employees from speculating and limited comments to this. "Steve, we thank you for your confidence and investing in our company but I cannot and will not speculate on when we will hear from the FDA as that wiould be doing you a disservice. I will not twell you what I think you want to hear! We have applied to the FDA for approval, we've answered all their questions and there may be more and we are just as hopeful of hearing the results of our applications at an early date."
Period.
What I wanted to check was Mr. Whelan's background re public companies. He's has some experience I see, but no indication of past work with the FDA on applications or approvals. This could be as simple as he spoke when he should've been very silent, as he is now. If so, he knows it better than anyone, but rant away bud.
Hey Steve - I totally understand your frustration on an intellectual level only, as I am not in your position and sympathize.
Ohhh ddls......ddls, ddls, ddls.
What has Mr. Whelan done to you to make you seem so bitter?
Fair enough......
All constructive points kid and taken in the spirit given - thanks.
To your last paragraph describing the 'why' a number of bitter people only submit venomous posts for publication, I like your all-encompassing clarification
"People have their reasons. Some have been burned in the past. Some are legitimate "bashers" that think they can influence the share price in order to buy in lower. And some just enjoy the dialogue." UNQUOTE
Some are burned and therefor bitter.
Some motivated by profit only BY making false statements
The rest just stirring the pot, dishonestly?
Freedom of speech is sacrosanct, but no wonder our country is in such a mess! I am reminded of the mis-quotes and innuendos so rampant in the political process, forever. Damaging there and damaging here as well to what I think is a potentially great company with great products. Too bad.
I am relieved tremendously, as the naive newcomer. I was fearful until now that some of the persistently negative posts may hold some truths and integrity - I now see we need not worry about that.
I wait patiently for the FDA approvals of ActiPatch and ALLAY, which, on the merits, I believe will come. Thanks again kid
Thanks Fuj - there are quite a few highly intelligent people posting here who are conveying the truths about BIEL and its product line and the status of the FDA process toward approval of ActiPatch and ALLAY. A few months ago I was totally naive on PEMF devices with a really badly sprained ankle. I was helped amazingly by ActiPatch and an old classmate in Toronto who sent a few to me and I felt grateful enough when I looked into BIEL to spend the time and expend the effort to share my experience with people.
The posters I refer to above have made that a lot easier - you, I'mRich, fuente, Walker - the good guys know who they are. Apologies to those I miss. But, but my point is, I don't see anyone who is simply hyping the stock falsely solely to make a fast buck in the next 48 hours of trading.
Making money is great, don't think I don't know that, but I read messages daily from people who seem to know a tremendous amount about the products, the background, the FDA process and the company - pro and con both. There are others who seem only bitter, not a place I would ever like to be. My thanks to the good guys for keeping this site real, balanced, and helping me understand what BIEL is truthfully about without venomous hyperbole.
I like where BIEL is now, management is being cool and professional, not alienating the FDA by inappropriately marketing in the US before getting approvals.
I noticed on Good Morning America this AM they were promoting a range of FDA approved devices - a laser hair remover, an LED light for aging and wrinkles and so on. Those devices are FDA approved, therefor they were tested and work for the claims they make. I compare them to BIEL products - no more laser clinic to remove hair, imagine the billions spent on creams and chemicals for aging and wrinkles, that my wife says do not work! And BIEL negates the need for taking drugs for many types of pain?
BIEL's RecoveryRx was approved years ago for post-op eye surgery patients, so for ActiPatch and ALLAY, in my opinion, this is not a matter of if, but when they are FDA approved.
Guys....what's up?
The company was not in compliance by marketing in the US while in the applied-for stage at the FDA. No criticism from the negative posters for that.
Then came the normal warning letter from the FDA, with which the company immediately complied.....No problem there, but the negative posters were critical. Warning letter, compliance, professional.
The company must not market in the US until it has FDA approvals in-hand, so posters now complain they are doing so elsewhere. I've spoken today with some people who know exactly what goes on and they say the FDA approval for BIEL's additional products will be like the Holy Grail. They also advise that by establishing trade relationships globally the company will be in a beautiful position to move once the overseas parties see the FDA approval.
The company has had FDA approval for 8 years plus/minus on RecoveryRx for post-op eye surgery patients by prescription. If the FDA denies approval on ActiPatch and ALLAY, is that to say they erred on issuing the previous approval on RecoveryRX. The FDA is not made up of morons, but highly intelligent professionals.
Why are so many pounding on the company, which is taking the brilliant path many have complained they did not previously - that is to remain patient and silent, thereby professional?
I wait patiently, I buy more shares at basement prices, as I can afford to, while the FDA does what it needs to do in the order it decides internally it will do things. I won't be buying shares at 25 cents. All the whining in the world will not change the FDA approval process. Stay silent management, you have my respect for doing so and your ActiPatch worked unbelievably for me.
I guess this is old news for most, but I just watched it and it's exactly what my buddy in Toronto sent me to use on my ankle.
My broker, who knows the whole BIEL story after doing some reading, advises that he thinks the pump and short boys are now out of the stock and things are quiet as serious investors wait for the FDA approvals. Nice place to be.
He suggests I consider increasing my position for peanuts to average down. I showed him one of the ActiPatch devices I have and he saw what it did for my sprained ankle. Another believer.
Not a chance - people are buying the millions of shares being traded and most are sitting patiently and quietly waiting for FDA approval, knowing the hard evidence in post 20157.
I spoke with someone yesterday with many years of management experience in the pharma industry and their comment was BIEL should do very well as a substitute for the current pain drugs. They then offered that BIEL is a likely takeover target by one of the drug companies. I simply smiled......
Best to ignore the naysayers, wouldn't you agree?
Hey Bull - think you're in the ball park on the full NASDAQ share pricing - sorry if I misled you - I meant the Bulletin Board of the NASDAQ where BIEL might trade?
Good to see doodles back at us with more derision and more hard fact DD and pessimism huh? He never responded as to where that negativity comes from disgruntled employee, shareholder or wherever
Try this doodles - since you are crying for hard evidence:
1. FDA branded approval of BIEL's RecoveryRx device for post-op eye surgery. That would be over the eye, next to the brain....yes, by prescription, find me one adverse side-effect
2. Multiple applications to that same august body, the FDA, for ActiPatch and ALLAY
3. Patented
4. ALLAY eases/controls pain and cramping associated with cyclical menstrual issues for women - thereby reducing ripple effects on let's see, the general well-being of women, families, workplace, etc., etc.
5. A whole list of other devices, either applied-for or in the works
6. A man named Gorsky has just been promoted to CEO of J&J and his previous assignment was heading up the devices division of J&J - now there's a guy who would know nothing about PEMF devices......
7. BIEL very unfortunately listed on Puiink Sheets where no brokers dare to tread, so marketplace doesn't see it
8. BIEL management has apparently stumbled repeatedly and many blame it's head, a guy named Whelan, but I don't see Whelan anywhere here except silent. And I don't see BIEL stumbling recently. If I had a buck for every mis-step I've made, well, you know the rest.....
9. BIEL gets a warning letter re promoting devices in US pre-approval and BIEL gets into compliance immediately
10. Still looking for one factual reason from you, based on your DD, why you believe FDA will not approve current applications.
Even if BIEL does or doesn't make it - give us just one factual reason today for your pessimism. Meanwhile I'm waiting patiently for the FDA approvals
Ha - thanks for the education sausage - much appreciated - I understand better now.
If I were Whelan, I still would have sold everyone to get on the NASDAQ BB - wouldn't you? I think people stumble over BIEL with it on the Pink Sheets - I'm told brokers never promote stocks listed there. Too bad
Thanks for the historical info Casper......
If I'm this guy Whelan and I own as much stock as posters are talking about, I sell the farm and my wife and her boyfriend and go to the NASDAQ Bulletin Board and run my company from there.
With FDA approval on his current applications on top of RecoveryRx, already approved, he's on NASDAQ. Drug free, chemical free pain management? What is wrong with these guys? $300G's? The stock would be at half a buck if given half a chance. Why the Pink Sheets? I'm still confused.
I only stumbled on BIEL because of a tennis ankle injury - same amazing healing story as you, my doc was stunned when I gave him back the crutches after 2 or 3 days. But without my buddy in Toronto who had a bad sports injury and used ActiPatch up there, I never would've known about the treatment or the company.
I read up on it and as I said, my broker laughed at me when I asked him to see if he could get me shares on a company trading on something called the Pink Sheets. I'd never heard of it. For my money, if you're going public, go public. You don't have to go the NYSE or LSE to tell 200 million or more people about your company - look at Microsoft - they did ok. And a silly little company with a really stupid plain name called APPLE. Geez, stupid name huh? Drug and chemical free pain management? Electronically? FDA approved?BioElectronics - Also a pretty stupid name. Imagine.
p.s. Here's a really stupid question - can my doctor prescribe a RecoveryRx device for me here in the US? I'll tell him I've got an eye ache.....
OMG!!!!! Do we know who the buyer was? Do we know if the information was correct? Or true? And, was that before or after the Health Canada approval?
How much of a depressant to the BIEL share price is the fact that it trades on the Pink Sheets. If, as many say here, Whelan has been selling shares to fund the operation pending FDA approval, wouldn't sensible management have spent the money to move the company to the NASDAQ Bulletin Board?
I might be picking at old scar tissue here, but I don't intend to, I'm just asking. My broker wondered about my sanity at my buying stock on the Pink Sheets until I told him the BIEL story of my sprained ankle and what little I knew about the new FDA applications. He thought I wasn't so crazy and bought some too. I just wonder what getting the company onto an exchange would do to get BIEL into a sensible environment for brokers and investors to see the company.
Hey Casper - thanks for the history lesson, I'm a relatively new guy here, having used ActiPatch sent to me by a buddy in Toronto on a badly sprained tennis ankle and couldn't believe it. That's when I checked the company out and bought shares.
You're saying there were PR's and a meeting at the FDA and those two issues were primary reasons enough to jump this thing to 12 cents? I just checked and it seemed to be trading around half a cent at the time. There are probably many more than a thousand meetings a week at the FDA! I cannot understand why this thing is trading where it is after it jumped approx 24 times over a meeting! Makes no sense.
Here we are wating for approval on 2 more BIEL products using the same technology as the approved RecoveryRX and it's trading at a quarter of a cent? I'm confused. Shouldn't it have stayed at the 12 cent region in an 'application pending' state and grown from there? Many other applicant companies have skyrocketed after making application to the FDA. And many of them had not the slightest chance of receiving approval.
I think you're right on what management should be doing - making deals and growing sales and that's what the PR's indicate they are trying to do.
Your message points to someone in 2009 hoping for approval in 3 months from the Sept meeting to Dec approval, isn't that kind of nuts? Was that investors, blog posters or management hoping that cause I suspect the FDA has never given approval for anything but lunch that quickly, so I wouldn't call that hoping, I would call it dreaming.
I think you're also correct that this is not an 'FDA or die' scenario as some may chat about. This is a company waiting for FDA OTC approval on ActiPatch and ALLAY, with approval already on its prescription product RecoveryRx - it is no more complicated than that.
If I get it correctly, they are already approved on ActiPatch and ALLAY by Health Canada - that would be Canada, not China or Cambodia, but Canada. How tough, or perhaps how on-the-ball is Health Canada to have given its approval and how long did that take. We are ahead of Canada on some things but don't those guys have more water than anyone on earth and more oil than the Middle East. That's what my Toronto buddy says and I've only been up there twice, but it's like being in any large city in the US with more money, less guns, less problems and they are polite! If Health Canada has any clue at all, I'm feeling good about the FDA approvals. Again, wish I had deep pockets, but I can't figure out what's holding the stock back....
Then, let's say there's as little as a 50/50 chance BIEL will get FDA approvals on ActiPatch and ALLAY for women's menstrual issues - I happen to think it's much higher given the existing approval on its' RecoveryRx. If the company didn't already have that FDA approval, that would make it a small newbie applicant, which would probably mean a much smaller chance of approval, but the technology and products are well known, studied and approved by the FDA. Am I missing something here?
Wouldn't the time to acquire a large stock position quietly be now, if you are a senior officer of one of the large pain medication companies like Gorsky at J&J, who already knows devices? He]], you could chip away at this thing daily, pick up 100 million shares for less than $250K, probably J&J's postage for a couple of days, while the FDA does its thing and then smile at 25 cents or better, as some suggest, having just made your company about $25million. Or, looking at it another way, you would have picked up a big piece of an approved chemical and drug-free painkiller device company for a quarter of a million to then take it forward. Wish I had deep pockets.
Thanks sausage - does a buyout make sense to you if BIEL receives FDA approvals on both ActiPatch and ALLAY, or is this fellow Whelan going to want to bask in the sunshine and take it forward himself?
Really smart players seem to take some cash and more stock, when acquired, so they can stand back and let the big boys with infrastructure and deep pockets make it happen......
Thanks very much for the info sausage - so apparently the 12 cent price in 2009 was not a result of a major announcement - I was trying to respond to the request for opinions on price by ieatcakemix and am still left wondering what it might go to on FDA approvals on ActiPatch and ALLAY if it popped to 12 cents on just the filing of the 501K Apps for those products??
On doodles post 20125, is he an embittered ex-investor, ex-employee or just a short-seller? One thing I know for sure is that I don't know where BIEL goes on FDA approval doodles, but if it goes to a quarter, or half a buck, or perhaps more, as someone suggested a while ago, I won't post a message to you, won't have to......but I am interested in your opinion of where BIEL goes on FDA approvals? Thanks
Over the weekend supernova12 in post 20111 responded to my earlier post that Whelan had been trying to solicit a crazy offer from big pharma for BIEL at one time. I had written in post 2010 details and an article from Bloomberg of major changes at the top of J&J March 14 and that a fellow named Gorsky has been promoted to CEO, from heading up J&J's devices division. BIEL, devices, J&J, painkillers?
My logical assumption had been that surely players in big pharma know of BIEL because of the potential effect FDA approval on BIEL's pain control devices might have on the chemical pain markets generally. I'm new at this, but it makes sense to me if folks can stop popping lots of pills with serious liver side-effects.
I did not realize I had hit a hot button re Whelan and big pharma in the past until supernova's response - does anyone recall details?
I saw that BIEL hit over 12 cents not long ago, apparently without a reverse split or major announcement - was the big pharma offer chatter the reason - does anyone know? If there was no major announcement at that time, then we know the price went to more than 12 cents on no major announcement. So, doesn't it therefor beg the question as to what it might go to on FDA approval which would be major? Who knows?
Thanks
sorry Fuja - re thanks but not my article....
Way to go Fuente, Finish and Fuja. I knew you guys would see where I was going.
And thanks Fuente, but not my article, just found it browsing around to gather info on J&J - here is the link on the Devices Division guy promoted to CEO J&J this week.
http://www.businessweek.com/news/2012-03-14/johnson-and-johnson-ceo-weldon-to-get-143-dot-5-million-in-retirement
I know it's Saturday, but I'm not hyping a thing here, just a naive, learning investor seeing something smacking me in the face with logic. J&J employee estimate is 114,000.
Here's what they do.....
Subsidiary companies (I think just a few of what they own and operate):
ALZA Corporation, ANIMAS Corporation, BabyCenter L.L.C., Biosense Webster Inc., Centocor Ortho Biotech Inc., Children With Diabetes Inc., Cilag, Codman & Shurtleff Inc., Cordis Corporation, Crucell nv, DePuy, Inc., Ethicon Endo-Surgery, Inc., Ethicon, Inc., Global Pharmaceutical Supply Group (GPSG), Gynecare, HealthMedia, Independence Technology, LLC, Information Technology Services, Janssen Pharmaceutica, Janssen Pharmaceutica Products, L.P., Johnson & Johnson, Group of Consumer Companies, Inc., Johnson & Johnson Health Care Systems Inc., Johnson & Johnson – Merck Consumer Pharmaceuticals Co., Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Johnson & Johnson Pharmaceutical Services L.L.C., LifeScan Inc., McNeil Consumer Healthcare, McNeil Nutritionals, Noramco Inc., OraPharma, Ortho-Clinical Diagnostics, Inc. OCD, Ortho-McNeil Pharmaceutical, Ortho-Neutrogena (a merge of Neutrogena and Ortho Dermatological), Personal Products Company, Penaten, Pharmaceutical Group Strategic Marketing (PGSM), Peninsula Pharmaceuticals Inc., PriCara Inc., Scios Inc., Tasmanian Alkaloids, Therakos Inc., Tibotec, Transform Pharmaceuticals Inc., Veridex, LLC, Vistakon
Consumer brands
Acuvue, Actifed, Ambi, Aveeno, Bactidol, Band-Aid, Benadryl, Benecol, Bengay, Benylin, Bonamine, Caladryl, Calpol, Calcough, Calprofen, Calgel, Calrub, Carefree, Clean & Clear, Coach, Coach Professional, Coach Sport, Codral, Combantrin, Compeed, Conceptrol, Cortaid, Cortef, Delfen, Desitin, Dolormin, E.P.T., Efferdent, Euthymol, First-Aid, Gynol, Healthy Woman, Imodium, Johnson's Baby, Johnson & Johnson Red Cross, Jontex, K-Y, Lactaid, Listerine, Listermint, Lubriderm, Luden's, Meds, Micatin, Monistat, Micralax, Migraleve, Modess, Motrin, Motrin Children, Myadec, Mylanta, Nasalcrom, Neko, Neosporin, Neutrogena, Nicoderm, Nicorette, Nizoral, Nu-Gauze, O.B., OneTouch, Pediacare, Penaten, Pepcid, Pepcid AC, Polysporin, Ponstan, Priligy, Provin, Quantrel, REACH, Reactine, Regaine, , Rembrandt, Remicade, RoC, Rogaine, Rolaids, shower to Shower, Simply Sleep, Simponi, Sinutab, Splenda, Stayfree, Steri-Pad, Stim-u-dent, Sudacare, Sudafed, Tucks Pads, Tylenol, Tylenol Baby, Tylenol Children, Ultracet, Vania, Visine, Zyrtec
My point is with 114,000 employees, 250 subsidiary companies, with operations in 57 counties and products sold in 175 countries, someone has seen BIEL and buying it is a rounding number on a P&L somewhere. With this many companies and products, and tens of billions in sales worldwide, they know about BIEL. They could even do a B&B deal to acquire BIEL and it wouldn't slow them down a bit. (Buy & Bury - just for the patents). But no one can convince me they don't know about BIEL or convince me that their devices division isn't interested in in a little company like BIEL with patents on drug-free pain management or promotion of recovery and healing?
And the man heading up their devices division was announced 3 days ago as the new CEO in April? And Mr. Weldon started in 1971 as a sales rep and cashes out 41 years later with 143.5 million plus he keeps Chairman? These guys are very smart players, the smartest of the smart, and can buy BIEL out of J&J's petty cash. They know.....
You may be right FGreen, but would you say the same is true about all the big boys in the pain market?
If I'm on the board of J&J and a competitor gets BIEL, I ask the CEO why he was asleep at the switch.....
It in inconceivable to me that Whelan has not made them all aware of exactly what BIEL is doing. I saw on the BIEL website somewhere that BIEL won some award as innovative product of the year or something. Memory is it was some association or media release? If I'm J&J, I've already sat down with Whelan.
I just found an article stating that J&J CEO Bill Weldon is retiring, with $143.5 million cookies, but is remaining as Chairman. Alex Gorsky is replacing him at CEO and guess what Mr. Gorsky has been doing for the last while at J&J. Here is an excerpt from the Bloomberg release March 14....
Johnson & Johnson (JNJ)’s departing Chief Executive Officer William C. Weldon will receive $143.5 million in retirement pay, the world’s second-biggest seller of health products said today in a regulatory filing.
Alex Gorsky is scheduled to take the helm of New Brunswick, New Jersey-based J&J on April 26, making him the ninth leader in the company’s 126-year history. Weldon, 63, who will remain chairman, amassed $95.1 million in deferred and long-term compensation during his 40 years with the company, where he started as a sales representative in 1971.
Weldon’s pension has a present value of $48.4 million, which he will receive in monthly payments after he retires, the company said in the filing with the Securities and Exchange Commission. His total compensation fell to $26.8 million in 2011 from $28.7 million a year earlier, the second consecutive annual decline, as the company struggled with recalls of artificial hip implants and over-the-counter drugs, and safety concerns involving vaginal mesh products.
Gorsky, who heads the devices and supply-chain units, beat out Sheri S. McCoy, the leader of the company’s branded-drug units, for the top spot. Gorsky was paid $6.8 million in total compensation in 2011 while McCoy received $8.7 million, according to the company’s filing. END
Huh???? Let's see - Mr. Gorsky heads up the "Devices Business Unit of J&J and beat out the gal heading up the "Branded Drug Business Unit"???
Patience friends - someone at J&J knows about BIEL, the already approved RecoveryRX and the applications in progress with the FDA. Bet on it!
It can't be much better than this fellow Whelan having them both up on the table with the most to lose. Unfortunately for investors, maybe yes, maybe no, that he seems to be learning on the fly and apparently has made a few mistakes, but I saw the pics of Dubai - this man has years of experience, staff and lawyers AND applications inside FDA on products similar to, or exactly the same as, RecoveryRx on which BIEL already has FDA approval.
Does anyone think for one second that Whelan and everyone else inside BIEL isn't crawling out of their skin with impatience? I sure would be, I'm twitching thinking about it. And the ALLAY application covers menstrual pain and cramps for women who will no longer have to take drugs every month? Huge market!
I like where we are and the fact that the guy who stands to win the most is the largest shareholder in the company. If I'm CEO of J&J I'm watching this like a hawk. When BIEL gets approval, it's an instant target! And if J&J gets it, J&J just bought an edge on all its drug competitors. Nice place to be.
I know I'm being repetitive, but it just makes no sense to me that a surgeon can prescribe the already approved RecoveryRx for me after he operates on my eye, to promote better, faster recovery/healing and I can wear a RecoveryRX next to my brain and the FDA won't approve ALLAY for women and ActiPatch for aches, pain, sprains, etc. I'm staying right where I am, patiently waiting for approval. Happy St. Pati's Day
Thanks very much for the good work fuente
A classic case of 'no news is good news'
As I have said before, the FDA has no interest whatsoever in harming BIEL or its investors. Just the opposite, its only interest is in helping the American public and it does an excellent job of that.
Patience is the key. In my view, it is unimaginable that the FDA will return a negative result on ActiPatch and ALLAY, given that BIEL already has FDA approval of its RecoveryRx device for post-op eye surgery use (that would be over the eye area and near the brain in a human, post-op?) and the advances in PEMF I've read about. No side-effects, no harm, no chemicals - what drug manufacturer can say that.....
I would like to know how many samples of ALLAY have been sent to the FDA for in-house testing by its female employees.... that would be a very cool clinical trial!
Fuente - I am totally confident you quietly saw where I was going with the thread of my questions......
My guess is there are very, very few bad apples at the FDA. Rather, it is most probably an org of the highest integrity, many thousands very bright people doing a great job of protecting the public - nothing is perfect, but doing well.
Got some data.....
October 2009 estimated employees FDA - 11,516
Article on Generic drug scandal
Generic drug scandal (Source Wikipedia)
In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.[17] Charges of corruption in generic drug approval first emerged in 1988, in the course of an extensive congressional investigation into the FDA. The oversight subcommitee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals)[19] pleaded guilty to giving bribes. Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S. Securities and Exchange Commission filed "securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.[17] END
patience is the name of the game......
Hey fuente - thanks very much for articulating answers to my questions......
I threw those out to madp, assuming he/she had a pretty good idea of the contents of the message regarding pharma companies paying the same "ton of money (an applicant would pay)X10" to have the FDA actually obstruct the approval process for application of a competitor's product. The allegation was made with such certainty, there must be some form of evidence behind it, don't you think?
This generated a high level of interest for me, in learning a little bit of what may go on in the FDA application processes and I just want madp to share his/her actual experience and the basis of the apparent certainty. If that is not forthcoming, then we can file the claim appropriately......
I'm pretty sure you will be patient with me, as we wait for the information to support the claim......I don't believe it myself, but only a fool doesn't change his mind, right?
Hey madp - I agree with some of what you say and understand patience and frustration go hand in hand.
I accept, as a layman at this, when you say pharma companies expense "a whole ton of money" to pursue FDA approvals - that only makes sense - time is money regardless of what party is investing the time. Why should the FDA be an exception?
Is it also not true that non-pharma companies also expense relatively huge sums to obtain approvals? Do devices, for example, require less time invested by the FDA to get to approved status? Less scientific data, trial results, chemistry, biology, disease, bacteria, lab work, etc.?
You also say that pharma companies expense " a whole tomn of money X 10" to prevent their competitors from obtaining FDA approval. Do you know of any factual examples of this or have any proof of such events and would this not be criminal behavior or obsttruction of justice or bribery?
I read from time to time of corporate officers and directors in various industries being handed their as*es here and in other countries for bribes, collusion, price-fixing and worse, but I don't recall reading of solid evidence that a pharma company actually paid the FDA to obstruct approval of a competitors drug. If you know of a few examples, would you please help me here? You may not have meant it, and I may seem naive, but your message implied that it happens regularly and I'm left wondering if you have any clarifying proof of this. An official accepting a bribe to do something is one thing, such unfortunately happens from time to time for various reasons, but common occurrence?
Thanks
Hey Fuente - If I'm out at the following prices.....at 12 cents pps I buy you and your wife a seven course dinner, mainland city of your choice, with hotel, I fly you there and back to your US city.
At 25 cents, include Hawaii from the west coast for 3 nights, flights as well.
At half a buck it's outa the park and I'll fly you there and back for 10 days, same deal and include dinner with this guy Whelan everyone is talking about because he will be my hero!
Is that dreaming? I'm not sure it won't be a reality if the company gets FDA OTC approval on both ActiPatch and ALLAY. That's a lot of horsepower against the drug companies and chemical painkillers and the consumer wins big time. That would make me very happy as I've been harping at my family to stop pounding back a couple of Tylenol or whatever other pills they see on TV every 4 hours for anything and everything imaginable. Maybe we take ImRich too.
Thanks Fuente - I know others were speculating a pps of 50 cents on FDA OTC approvals not very long ago, but my guess is that included approval for the applications in process now, ALLAY, ActiPatch and whatever else. Makes sense that an approval for ALLAY alone may drive it to 12 cents and then ActiPatch, etc., beyond that.
I am interested to know what ImRich thinks - or anyone else with a feel for such things - I know I have no idea except any FDA OTC approval for the company should only mean positive things ahead.
Hey ImRich and Fuente - do you have any thoughts on what the pps may reach if just ALLAY were to receive FDA OTC approval before ActiPatch? I hope I'm not jumping the gun here, just curious.
The ActiPatch for strains, sprains, bruising etc., etc is one thing, but I have long seen ALLAY for women as a potential goldmine for both consumers suffering from medium to severe menstrual cramping and the company. Then I think of every pharmacy in the US..... That might mean we get P&G into the game (Tampax & Tampons) as well as J&J - Tylenol, etc.
I only have the data I read on the website, but it does not seem much of a leap given that the company has had approval for years for its RecoveryRx for post-op eye surgery applications. The costs to society resulting from female issues are in the billions of dollars in terms of lost work days and lowered productivity, without even considering women suffering monthly and the ripple effects of those close to them at in the workplace and elsewhere. If women could be drug/chemical free for these issues, I see that as huge potential. The market is immense here in the US and beyond and I guess ALLAY could be identified as a consummable, month after month after month.
Thanks for any thoughts you may have.
Hooray - you make me feel soooo good - "the science is great". I appreciate that! It endorses that my investment based on actually using the BIEL science on my sprained ankle was not isolated.
If one follows up on the Advisory Commitee to the FDA recommending the end of acetominophen because of liver damage (see the posts last week)do you not think it makes sense for J&J to acquire BIEL? If I'm the J&J CEO, I'm all over Whelan! If I'm CEO of a J&J competitor, I'm in the game to get BIEL and save my company.
Or even better, to do a JV with BIEL and therefor monolize the OTC the pain control market?
That way the Whelan knockers and management knockers would still have a whipping boy and ActiPatch etc., sales would fly off the charts and the investors win big time.
If you had gone to regulators 40 years ago with ActiPatch, you would not have had a reply, you would have been laughed at. Now, we have FDA approval of BIEL's RecoveryRx device by Rx only and applications to go OTC for other indications. Is there not now a specific group handling devices? Americans are getting sick of the damages caused by popping pills. I think BIEL's time has come.
There are hundreds of examples of drugs being launched as Rx and moving to OTC a few years later - Zantac from GSK for ulcers is a perfect example. First by precription, then like candy. The FDA knows what it is doing, we must be patient and BIEL management must be quiet.
Unlike others, I am not interested in promoting some guy's company or share price. I am simply sharing that ActiPatch worked for me amazingly well. For me it was just common sense to risk a few bucks in BIEL shares based on the common sense of it all. As you say, it's about the science, we can all forget about Whelan and anyone else.
I agree on all your points kid-they are good ones and I overlooked the accountability aspects. Whalen is the CEO or whatever and totally responsible for what is submitted to the FDA. But, he is not responsible, nor does he have any input to, the Administrations' approval process after that, unless asked by the FDA for more data or work to be performed, then he is totally accountable for that additional input.
I guess part of where I was going is highlighted right at the end of your message where you say he is responsible or accountable 'X1000'. Is that the same as if a child misbehaves, why give him or her just a time-out when breaking their arms and legs will teach them a better lesson? You seem angry or vindictive toward Whalen and I don't understand why? I read somewhere here that he worked in the pharma business before, but that doesn't mean he steered the ship through the FDA process. Wasn't he involved on the accounting side? That is hardly the regulatory side. If you told me that the company didn't have the money to hire top-notch FDA process nursemaids, or that Whalen simply shot his mouth off, I would believe that. Or, if Whalen did not know the FDA processes cold, I would believe that too. But it does no good to fester on the past-Whalen seems silent now-good. I want to focus on the facts that BIEL has applications with the FDA in play, received a non-compliance letter which it reacted to and BIEL has asked for OTC approval of products previously approved as post-op eye surgery Rx products.
Seems to me that there is too much blame of Whalen - he is only the CEO and will not figure in the decisions of the FDA.
The FDA is the government agency charged with the responsibility of protecting the public involving hundreds of thousands of products, millions of claims and every comma and hyphen. FDA employees are people with jobs, just like us, but with a bigger responsibility - protecting us from harm. So, my opinion is Whalen and investors here have nil effect on the FDA.
A buddy advised me that what matters is the process of assessing data as part of applications for approval. Millions of items of data in hundreds of thousands of applications, usually on a first come, first served basis, unless an application warrants a fast-track designation. He went on to say that smart people tet the FDA follow its process, without being alienated by pests and indignation.
With the simple, straightforward, NORMAL, everyday FDA warning letter as to compliance, my buddy said BIEL erred and corrected its position and activities after receiving the letter to get itself back into compliance. The system works and BIEL staff admitted it had made the changes necessary to comply. We have not heard a 'no' from the FDA - BIEL has a 'yes' from the FDA on RecoveryRx, so don't we just let the process eveolve? Am I crazy, or do we simply have to be patient and just ignore the ignorant naysayers? The product works and is approved on post-op eye surgery patiens by Rx. Isn't the logical next step OTC for other indications that may help us all? I've used ActiPatch on a badly sprained ankle and know it worked amazingly on me. Anything else in nonsense!
Seems to me that the New PRC is enjoying incredible growth and certainly the urban standard of living has improved many-fold over the past 20 years. Further evidence of its' growth and prosperity is the PRC is also the largest holder of US debt instruments by a huge margin. Sorry to bore everyone, but US debt has risen $500B each year since 2003 BUT $1 Trillion in 08, $1.9T in 09, and $1.7T in 10. It was 15.5 Trillion March 1, 2012 with the PRC holding 26%, or over $4 Trillion of it. With a population over 4 times that of the USA, it's a great market.
But, there is also an interesting anomaly in the Chinese urban numbers - they are not all poor rural folks. China has 171 cities of over 1 million, 279 with 500K to 1 million, for a total of 450 cities over 500K. Here, we have 9 over 1 million and 24 with 500K to 1 million for a total of 33 over 500K (2010 #'s). So, China has over 14 times the number of cities we do with over 500K people. That is a powerful urban customer base.
If BIEL makes a deal to do all the manufacturing and assemby of its devices in China for pennies for the Chinese market, compared to any of those processes more expensively in the US for this market, and sell them there as well under its Chinese patents, doesn't all that bode well for shareholders?
Chinese medicine doctors have traditionally been more open-minded than doctors in 'Western' medicine and they've only been doing it for a few thousand more years. I am wondering, does BIEL have regulatory approval in China, and if not, how difficult is the process to obtain it?
Thanks fbs - I went to the link you put up on your last message and read it with great interest....
QUOTE
"FDA Advisory Panel Recommends Banning Vicodin and Percocet
Why ban Vicodin and Percocet?
An FDA advisory panel recently recommended banning Vicodin and Percocet – two of the most popular painkillers available – due to concerns about the amount of acetaminophen in the drugs." UNQUOTE
As a total layman at this, I feel somewhat vindicated that I have been harping at my family that we, including yours truly, should stop popping Tylenol and other painkillers in quantity every time the wind changes direction or when someone gets a mild headache or sports injury, mild or serious. After surgery for the management of intense pain? No problem. But not at the slightest whim.
I based it on my feeling that even the day to day milder chemical painkillers are just not good for us. How many Tylenols, or similar medication, does the average American take over a lifetime? I'd hate to guess. There is no hint of such side-effects with BIEL's ActiPatch that I used and since BIEL already has FDA approval for its doc prescribed device for post-op eye surgery - let's see - around the eye? close to the brain? to promote healing? And no side-effects? FDA approved? What's to figure out with the other BIEL devices?
Has anyone seen any sales projections from BIEL? I would love to know what the estimates might be if the FDA starts shutting down some of the chemical painkillers. Is the FDA powerful enough adminstatively or politically do order that or is it just nonsensical rhetoric on that website? And would members of the public even learn in such a manner that the FDA is considering such a concept, or what one of its Advisory Panels was recommending? In other words, is the article credible? If so, isn't it good news?
Thanks
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The reason the FDA is considering changing their recommendations is that acetaminophen overdose is currently the leading cause of liver failure in the U.S.
Just curious - is it out of the ordinary at all that BIEL has not traded as of 12:10PM? Checked 2 sites and the pink sheets and zilch??
Thanks
Buyout price is always an interesting topic.
Can you imagine the boardrooms of all the big pharma firms, with outside directors asking the boys who run the firm, "You could have bought this bioelectric or whatever the name is for a couple of billion, before they got the approvals and we would have had the patented jump on every pharma firm in the world, by controlling the device pain treatment market, where were you guys?
And then, "On a multiple basis BioWho is going to do a billion a year globally on just the PMS patch and you guys let this one get away? Why didn't the guys at the FDA let us know? What was going on? Was everyone asleep?" Presidents will be diving under the table.
Can you hear the whining and gnashing of teeth? My take is whoever gets BIEL is going to be in charge for a while and it may just be BIEL in its present form. If they get FDA approval, which is only logical, given that they already have it on the post-op eye surgery device, maybe they will have enough dough in the kitty to rock and roll.
Right - and if it is something different, which happens to go against the mammoth chemical drug manufacturers, is it not reasonably logical that the FDA would want to be totally rock-solid of its approval and does that not take time?
When I wondered as to how significant BIEL's devices might really be, particularly ALLAY, I simply went to a cupboard and counted all the partially used drug painkillers there are in our house with 3 females 15 to 40 - it's nonsense. I'm a guy, so what the hay do I really know? But the concept is intriguing.
Went to a population website
US female - 2010 - ages 15 to 49 - 75 million approx
Then BIEL website says study results were 77.1% of women using ALLAY had complete elimination or significant reduction of typical menstrual symptoms
Went to several sites - numbers vary - but generally 40% of women suffer painful cramping, 10% are incapacitated 1 to 3 days - can you imagine the cost and emotional fallout of this? On the poor women suffering the problem and those around them?
Then I did a little math: 75 million women 15 to 19 - 40% with pain every month, that's 30 million - if ALLAY market penetration was 5% of that number, that's 3.75 million - times 15 bucks (I have no idea of the price of ALLAY but that's 5 coffees) - that's $56.25 million a month or $625 million a year. and it doesn't include the other 45 million women who may want to use ALLAY occasionally! Or, according to the cencus, women in the military overseas who would probably be restricted from using ALLAY so they could just scream and throw stuff at the Taliban and keep 'em in line that way, who needs guns?
Forgive the lame humor, but isn't that a lot of dough? Next question is what percentage of women who suffer from menstrual cramping have chemical painkillers in their possession for treating the pain - and is my 5% figure therefor conservative when one thinks 5 years down the road as BIEL or J&J or another big drug company works on creating ALLAY as a 'Brand"?
I need fuente and the sausage to throw some logic on my thinking and numbers - seems like a lot of cash flow to me????
Thanks very much for your wisdom - much appreciated and confirms my wondering,perhaps correctly, that BIEL's devices may very well represent something quite substantial in getting humans away from ingesting chemicals. I am not a tree hugger or radical in any way, but my family is eating better, smarter, organic vegetables where possible and our awareness levels of such advances in lifestyle are way up, etc.
My main observations of how we seem to be doing much better than 30 to 40 years ago are: the fall in the percentage of smokers and non-smoking areas, fines, etc.; the ratio of obese vs non-obese people in the western world and the govts & media talking about that - epidemic; and, who 30 years ago read labels carefully prior to purchase? A tiny percentage compared to today's consumer. Can you imagine if the chemical painkillers we pop by the billions were reduced?
Thanks again