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No they're not I'mRich - I'm busy. Just nothing in it to go on and on in the face of incessant negativity from those who are not busy.
ActiPatch works incredibly well....that's the story
Greetings to all the good guys & gals - you know who you are
CHEERS!
Anyone know the likelihood of a double play - back to back letters of approval on ALLAY and ActiPatch? Or, the probability that the FDA would approve ActiPatch alone in August or September after the July conference call, ActiPatch having been around longer and ask for more clinical data on ALLAY to perhaps save face in light of the rejection and appeal?
Steve - yessssss. Some had picked up on this and asked many questions, one being why shares are not purchased again using profits to date - no answer. Good work my friend.
Just noticed something I had not seen before:
On the page of FDA approvals, I note an addition which is dated July 5 2012, but it was not there yesterday, so there is a lag time of 6 days plus/minus from when an approval is issued and when the FDA FTP's it up to its own website. It takes one minute in the hands of a good webmaster to FTP the information to update the web page. Here's the link.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm286493.htm
What is also interesting is that there have been 26 device approvals this year, 10 of those devices involving stents.
Would it not be interesting to see how many are stuck in an 'applied for" backlog? I would bet a lot of money that that number will never be known by the public. It would also be interesting to know how many FDA people are assigned to the relatively new 'Devices Division' and getting those applications processed to decision. I do not say these things to be critical, but to draw attention to my suspicion that the FDA may truly be underfunded and understaffed as a result, while Washington distributes pork $$ in ever increasing amounts to states for 'nothing but votes' projects. No wonder we're in financial trouble. We don't pay our cops, firemen and the FDA enough to operate safely and efficiently, but we spread the gravy allllll over the place. Your and my taxes.
Like fine wine, as long as it takes. No need to ask repeatedly.
Perhaps because the value of the fill is $500? I had the same problem trying to increase my number of shares, doing it 100,000 shares at a time, and was essentially ignored until it was raised to 500,000 at a time. Then I was filled in 2 minutes - it's the market makers on the Pink Sheets. Filling orders is at their whims. One of the reasons I remain amazed that the company has not taken funds and moved to the OTC:BB for share price, exposure and number of shareholders, etc., etc.
Hey fuente - so perhaps the underlying attitudinal reasons are found in the failure of a 'tinge machine' to solve back, shoulder, spinal or other issues resulting from a fall off a ladder by a loved one? Therefor, ALL such machines are failures, fraudulent and quackery? Makes a lot of sense for someone to have a global response like that, particularly if the loved one suffered for a long period of time. I hope that is not the case, as no one deserves that.
However, a blanket attitude such as above is like corrosive acid, eats away at a person. We all know BIEL products provide dependable relief as marketed and are safe. One already approved by the FDA and hopefully many more to come using the same technology and not one negative side effect to date.
Buying em all today - he's a big supporter of BIEL so he'll advise us all tomorrow as to how many he picked up
it would be really intersting to know who picked up those 5.34 million shares......
The ActiPatch working, not the ankle.....
got it Super - thanks very much.
And philosophically, I smile broadly each day because after 23,000 posts on this board, not one of the naysayers has come up with one iota of negative ammunition about BIEL's products not working exactly as advertised, or one negative side-effect. A beautiful thing. I, on the other hand, have tried it and it worked perfectly on a badly sprained ankle. A thing of beauty!
Very astute disciple - you may well be correct.
What tweaked my curiosity was this....
After the fujimaster asked Alan Gorsky's group at J&J if they had any interest in PEMF, a dialogue ensued and they responded, "yes". This was not a slip on the phone, someone actually sat down at a keyboard and communicated with fuja21!
Then fuj mentioned 3 things - ALLAY or ActiPatch, BIEL and FDA approval.
The response to that was not - "our policy at J&J is that we do not discuss specific products, companies or FDA status"....
No. it was, "we can not discuss this further". It seemed a little abrupt to me. I certainly don't want to chase butterflies here, it just seemed odd. Personally, I would have picked up the phone and asked that person why they could not discuss it further, with a huge spoonfull of sugar on top, to see what response I could generate. Who knows what companies BIEL has been in contact with? Time will tell.
Ha! Thank you disciple - I browsed and found Fuja21 post # 23365 you had found. What is your take on reading it again, am I nuts?
If I take it apart here, as I did when I first read it, one can see the thread.......
J&J ..... no doubt interested in BIEL based on my on DD, .................................. I sent several emails to Alan Gorsky and his group ..........re their interest in PEMF ....... which began a "dialogue" (back and forth????)
"yes" they do hold an interest in new technologies of that nature. ....minute I mentioned BIEL product ......and ......upcoming FDA approval all contact was dropped
AND
"and they said they could not discuss any further."
I'll repeat - they said they could not discuss further......
Not, "I don't want to" or "I don't have time" or "we don't respond or comment" or "against our policy". None of those - it said they "could not discuss further".
That dialogue told me the person writing e-mails for J&J was already in a dialogue with fuj21, whether that was right or wrong, then they discussed it with a colleague, perhaps a supervisor, or perhaps someone way up the food chain got wind of the dialogue, who told them to cease and desist. And the dialogue door slammed shut. Why?
As fuente said - companies do not engage in such dialogues normally, this was not normal, fuja21 got to someone who engaged, then "could not discuss further"
thanks illuminati - the poster involved had some back and forth dialogue going on when J&J clammed up as I've described. I noted it with a little amazement at the time, however I made no comment. The writer will surely remember and I'll go searching a little - too bad there isn't a search engine for iHub posts - maybe there is and I don't know about it. Thanks
you must have missed the post....someone, I thought it might have been you apologies) called or was e-mailing with J&J on BIEL and they completely clammed up at the information that BIEL was awaiting FDA approval. It was not by simple silence, it was an overt clamming up. It was as if someone had directed the employee to clam up. Can anyone help here? I know I read that on a post quite recently.
fuente - was it you who called or e-mailed J&J enquiring about potential interest in BIEL and when FDA approval was mentioned, they clammed up? I found that post and abrupt clamming up very telling.
If FDA approval is given to ALLAY and ActiPatch, you are right, BIEL management may not have the global marketing talent or funding to go forward, but do you think a buyer will care if it pays 10 cents or 25 cents? With approvals the price will be moot at under a quarter, maybe more, if the Whelan family holds onto a large portion of its shares. A buyer may simply want control and to hold onto the technical, historical and relationship knowledge Whelan obviously has. Or, a buyer may not want Whelan to cash out at the time of an acquisition.
I'mRich - approval of ALLAY and ActiPatch by the FDA is a huge thing! You watch, Challenge is not a fool, he was long BIEL and rode it up to 12 cents and down again, BUT made a profit, almost doubling the investment. The underlying issue is that it was a smart investment and we are still in the game for FDA approval same as before. You watch, there will be a few million shares traded today as Challenge loads up again. He's no fool!
Wow! I guess I must have missed one of those messages by I'mRich predicting BIEL at 20 cents this summer based on FDA approvals for ALLAY and ActiPatch. He has always portrayed himself as level-headed and very knowledgeable on the pharma industry and particularly FDA approval processes. Thank you for re-posting them both. Much appreciated!
Cheers!
Congratulations Challenge - you more than doubled your investment in 2010. Not a 10 bagger, but you are way ahead of many others who are underwater.
I'm confused by your claim that BIEL should be doing very well globally without FDA approvial and OTC sales here. You know, as everyone does, that is contrary to fact. FDA approval and OTC sales here will launch global sales, not only because the US is THE market by far, but also because the approval here will create the required aura overseas, media coverage, etc. Even Canada follows what sells in the USA. I suggest you take your original investment plus the matching amount of profit and buy shares now in anticipation of FDA approval. With your knowledge of the company and its products, you also indicate you know they work, with no, not one, negative side-effect. Good luck on your investment. And thanks for your historical perspective.
Good post 10-4. Could it be that the poster you refer to states or strongly implies that the MM's control the BIEL board because the poster has inside knowledge and is wearing that team's sweater?
To actually say, "the Senator will have no affect on the FDA DENYING this application.". Amazing. Who do you think pays the FDA bills? It is all a process, a political process. BIEL and the FDA are doative side-effects, like all of BIEL's productsing the right things. Application, erroneous letter of denial, appeal, Senator, Director, Inspector General, big ole meeting and then the intelligence kicks in - BIEL's bio-physicist speaks to a group of 20 FDA'ers and whaddya know - ALLAY really works and is totally safe with ZERO negative side-effects, same as all of BIEL's products, especially RecoveryRx, which we've already approved as an Rx device. Hmmmm, these devices really are the coming thing and it is, after all, a harmless substitute for acetaminophen and we kinda need some drug-free, harmless publicity
To actually say, "the Senator will have no affect on the FDA DENYING this application.". Amazing. Who do you think pays the FDA bills? It is all a process, a political process. BIEL and the FDA are doing all the right things. Application, assessment, questions, answers, erroneous letter of denial, appeal, Senator, Director, Inspector General, big ole meeting and then the intelligence kicks in....
BIEL's bio-physicist speaks to a group of 20 or so intelligent FDA'ers and whaddya know - ALLAY really works and is totally safe with ZERO negative side-effects, same as all of BIEL's products, especially RecoveryRx, which we've already approved as an Rx device.
Hmmmm, these devices really are the coming thing and it is, after all, a safe and effective substitute for acetaminophen and we kinda need some drug-free, harmless publicity cause we did kinda approve acetaminophen way back when and now everyone is sticking it into their products and the public is taking it here, there and everywhere and they don't know it and now its a major cause of organ damage in the US....oops. And, we're kinda new at the device business, after all, it hasn't been around very long, who woulda thought we would have a devices division, just like J&J?
FDA Director letter to BIEL - How can we get a few dozen more samples of ALLAY here at the FDA for testing? (And, just between you and me, our female absenteeism record is unbelievable! I should know, I'm not at home feeling really crampy and in a lot of pain, but I know I'm gonna need more ALLAYs when this batttery wears out, I've never felt this good.) And if you could shoot me, say three hundred ALLAY, that would get a lot of my staffers off my back. Thanks Mr. Whelan. p.s. Oh, and if you could throw in 200 ActiPatch, our FDA Tennis Club will stop whining for them too, cause they can't buy em in the USA yet. Thanks again.
An incredible amount of time, effort and half-empty spinning following a declaration something like, "if I owned this stock", meaning - not - and was going to move on. Leaving one to wonder as to motive.
I am long BIEL, I know first-hand that ActiPatch worked extremely well on a badly sprained ankle and can now advise those who may be interested that I received info from my buddy up in Toronto that it works amazingly on tennis elbow. So, with all the trials and data showing BIEL's products, ALLAY, ActiPatch, RecoveryRX are incredibly effective, and not one negative side-effect, the naysayers are just noise without foundation and for personal agendas.
GO FDA and go BIEL!
Hey Casper - $50 plus is a ton of money for any BIEL product in my opinion. But first things first - the approval of ALAY and ActiPatch. I see that 11 stent devices made the Hit Parade out of a total of 23 Medical Devices Cleared or Approved by the FDA between Jan 1 and June 1 of this year. I am wondering if BIEL could possibly have the stent guru break off and look at ALLAY and ActiPatch?
Hey Johnny - the King does not know that the 20 FDA employees, both experts and executives attended the BIEL review meeting so they could advise on warnings that need to be placed on the boxes of ALLAY, however, the King would probably not comment on that, although it may be the case.
Also, on walker 429's informative post 22999, I personally see no advantage in Dr. Jeffrey Shuren, the FDA's top device regulator stating for publication that the agency had mishandled the MelaFind application.
Although I admire Dr. Shuren's transparency, I believe it is perhaps better to leave the dignity of those employees within FDA, who indeed may have mishandled the application, intact. It is alleged that the same thing happened with the BIEL ALLAY application, however, they don't need a public bashing as well.
Much more diplomatic to encourage people when they err than to appear critical. They will work harder, produce better work product and remain loyal. People know when they have screwed up, is it not better to seek additional positive amendments to areas like package and insert wording and warnings, as you suggest, and issue an approval?
You are correct - As you say, it is time for you to move onto your next FDA play, no need for you to hang around here.
Hey Superstar - I think I'm Rich was bang on re FDA approval timing coming whenever, but perhaps this makes sense to:
If I were king of the FDA, here is what I would do:
I assume that, in addition to the BIEL physicist presenting technical and scientific information to assist the 20 or so FDA people in attendance at the review meeting, the company would also have left hard material and electronic (CD) data too.
The FDA people should, either in committee, or by area of expertize, assess every detail of the material AND every word stated by the good doctor with the goal of 'get it right', which is claimed by the appeal, they did not.
That will be checked and checked again in-house at the FDA and a decision rendered. How long that takes is anyone's guess.
Perhaps not very helpful, nor what you want to hear, but we are not talking about choosing one flavor of cola over another in Times Square either. And a careful review process and proper decision will get the Inspector General and all the Senators off my back! Since I am the King of the FDA, that is very important at budget time.......
Hah! I can't wait for the shorts, if it is even an issue, to be squeezed to cover when the FDA gets its house in order.
Think you're right Super - someone was almost too nice and helpful - "now you've got it" - thanks for this and that?
Hi Stingbee - based on the last paragraph of your informative post, would it not be wise for BIEL to use funds, apparently being raised for operations by the sale of shares, to immediately move to the OTC:BB where there is at least more oversight than on the Pinks?
It has always seemed to me that such a move would attract many more investors and real dollars, whereas investors shy away from the Pinks.
see 2nd paragraph....
Hey Super - I too did research last nite into Terms of Use and Level 2 purchase since many posters refer to L2 data. I had posted several times re post 22850 and all were deleted for no explainable reason. So, I am with you.
Well said Bully - if this stock was trading at $16 and fell off to $12 that would also be 25% - big deal, it is more than double where it was a few weeks ago. A penny or 5 are not so far away, you're right.
No problem speakhim, glad to:
A multitude of clues which tweak my instincts, can't say more than that, but my instincts are often reliable:
The official silence of BIEL - rare in the past, the CEO is silent;
Paul, an IR fellow, advising investors of meeting with FDA;
I do not have an answer re # of shares traded today, but someone (plural) is buying and I have tried to solicit opinions on this from good guys here, but everyone is busy and I am patient;
The occurance of all this seems timely - a few weeks after BIEL raised the issue that the FDA missed something on ALLAY, OR BIEL was less than clear, I don't really care which, as long as it is/was clarified. They involved the correct people, legal counsel obviously wrote the letter to shareholders, Senator Mikulski of Maryland, the Inspector General became involved, Senators are writing response letters and I know Senators,and Congressmen and Mayors, whether sitting or candidates, avoid losers like the plague - there is nothing negative about BIEL's products. No nastiness, only professionalism that something had been missed, normal regulatory process steps;
There is no factual reason for FDA declining anything with regard to PEMF and BIEL's product line, its been around for 30 years, but obviously there is still pioneering going on.....devices are still fairly new to the FDA wheelhouse and a device to replace painkiller drugs? Nonsens!!! But you watch - my prediction is PEMF devices will be out in the main floor area in US drugstores because there are NO ADVERSE SIDE EFFECTS, something I would respectfully suggest puts everyone at the FDA a little on edge;
My first-hand experience with ActiPatch (only) was amazing. It reversed a healing prognosis from an excellent athletic doctor on a badly sprained ankle from a couple of months, because he said a really bad sprain is often worse than a fracture. He was convinced I had broken it till he read the X-rays. To my returning his crutches after a few days and walking easily on it - incredibly reduced swelling and healing - he and I both couldn't believe it!;
Small companies with little money take tiny steps and it seems to me that BIEL has made errors in the regulatory process due to inexperience. Doesn't bother me terribly, but it is frustrating and it just takes longer, while the patent clock ticks;
There are emany other clues, but who really knows what contitutes instincts, and I'm pressed for time. A major clue is I'm in this for the long haul, not to play the long and short swings combined with no one has even suggested it does not work or that there are adverse side-effects and I smile.....
I'mRich, Super & Sausage - is it possible that BIEL is now paying its current and past consultant fees by giving them stock which they MUST sell now and BIEL is actually buying it back quietly? Does that make sense? No question in my mind, something is up, would love to know what it is.
Hey Wyatt - well done! Interesting response from the good Senator which seems to be begging for a follow-up phone call to one of her offices in NY, since your letter involves a federal agency. FDA is a hot topic these days, as you and all Senators know. When Senate staff put together a weekly/daily bullet update, they love to have actual examples of hardship or snafus.
With such a call, a caseworker will look up the letter you received, which will be stored by your name and probably BIEL's. The caseworker will then see or listen to the story. Double coverage and the Senator's staff will not have to do any research, which is why they rely so much on citizen input.
Those in favor? Carried!
Go Fuj......
Ahhhhh - someone bit
"The lady doth protest too much, methinks.......Act III, Scene II.
To my knowledge, there has been no accusation of anyone being an employee of BIEL - it was ex-employee or ex-consultant, and it was not an accusation, but a question. I would be proud to be an employee of BIEL - I know I would make a positive contribution. As a matter of fact, one of the learned investors on this board suggested I should be CEO. No intended or inferred slur, no insult, no foul, anywhere. But why such a tizzy?
At a buck a share, I may be a seller. How bout you?
I'll wager that BIEL could be bought lock, stock and barrel for less than $2 Billion