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I nominate Horus to go into FDA as a divisional director, or higher, to clean up the backlog by Wednesday lunch. Shouldn't be too complicated, "Whaddyamean new application? Just send me something, coupla paragraphs, a one pager should do, you can even back-date it if you like. What paperwork? It works or it doesn't. Don't confuse this with science! I'll just sign it and you can pick up your approval at the front desk before 4. And don't worry about the regulatory breaches of whatever, they didn't happen! By the way, what class do you want? For an extra $20 bucks, why don't you get 'em all? Then you don't have to come back for more approvals. And for $50 bucks just fill in Thermal AND non-Thermal, then you got 'em both covered! And stop wasting my time. Next application? Hurry up, I haven't got all day!"
Are you kidding me?
I agree completely mad, but it seems to have kept the company alive. Hopefully, it is relatively short-term until BIEL gets the bloody approval for OTC here in the US. I am totally confident this will happen and always grimace when I see your frustration and anger pop through. Patience my friend - getting picced does nothing! This is business and FDA business takes time and a lot of money!
The good guys see my point in the next message - as I'm typing that one, large toes puts the other foot right in there after the first one. Some things are just meant to be. Weekend expenses, what nonsense!
Just food for thought
Many posters whined about Whelan diluting to raise money for his personal lifestyle and travels.
I don't buy it. The guy does not live and extravagant lifestyle.
Why do I say this?
I'm reading a report just received on a company I am heavily invested in with applications in the oncology, cardiology and diabetes spaces.
Patented, breakthrough stuff.
Company has a monthly spend that has climbed dramatically over the past three years - total spend now north of $100Million.
I invested more recently, does not trade publicly.
Three new trials under way concurrently.
Fasten your seatbelts . . . . .
Cost per patient average over 3 trials?
Over $90,000 per patient!
Cost per patient during first trial 8 years ago?
$13,000, and investors and management were going nuts then.
BIEL has completed a lot of trials and beefed up its IP with numerous new products and new patents or add-ons to existing patents.
I say that's where a lot of our money went. Perfect!!!!
Just trying for balance here
Good get king
- why wouldn't the puppy be climbing?
- drug-free
- side-effect free
- patented
- FDA just proposed a new device class which will fit BIEL
- scheduled to become reality in May - FDA's timing
- BIEL applies, FDA suggests 90 day review pre-decision
- little, if anything FDA doesn't know about BIEL ActiPatch
- hope Whelan shows humility and apologized to FDA if rude
- hope Whelan retains heavyweight pros, if needed to help Appl
- yup, sure did dilute to keep the puppy alive
- do I care? No
- repeat - patented - unique, protected IP
why wouldn't it be rising? I don't know!
Thank you for the earlier Pollux - if our kids listened to and followed half of what your son so kindly sent you, they will be winners in life!
That would be Mr. Sonny, Dude.
I think you're on the right track with BIEL - it will be immensely successful if they obtain FDA approval.
Some derive pleasure from antagonizing the negative reaction of others - it's a form of attention seeking, Dude.
Thank you Cdub - brilliant work - assume it was you who spoke with, or wrote directly to, the PR executive?
I agree, it will take at least until May and after the FDA receives comments and feedback on its proposal of a new class of devices and makes its decision, etc. Fair enough.
But, my instincts cause me to wonder, albeit as a layman on FDA Reg processes, that management at FDA may be able to do pretty much what they like. How often do they create a new classification these days, anyone know?
I can't imagine a restriction to them determining that they can indeed accept previous work that they themselves have spent a fortune in time assessing BIEL's application and those of other device applicants and simply deciding that those applications may be approved for the new classification they themselves are creating. I can hear them now, "Well, we spent 7,000 hours on these 19 applications and they did not warrant approval under the classification they fell under then, but they will meet approval requirements under the classification we're proposing now, so instead of re-inventing the wheel, why don't we save ourselves another 7,000 hours, just on our side, and approve the applications, providing the applicants provide affidavits that the devices previously applied for have not changed. If they have been changed or approved, or if new trial data exists, then the applicants can provide a supplemental form or amendment and we will review that"
Is all this logical or am I crazy? Seems to me that the applicant firms can save millions and the FDA can save many thousands of hours of work. To assist and if interested, please see my previous post #35395. Thanks
Rich, fuj, Casper et al good guys -
Is it even remotely possible that the FDA can simply reverse its previous decision of denial on a 510K application by saying that regulatory parameters have changed to allow approval of the denied 510K by virtue of the creation of the new category by the FDA?
Of course, the next logical question is, if not, why not?
It could become a simple re-assessment? Unless, of course, an applicant wished to submit updated data, etc., etc.
I resent being called just a finely tuned violin - call me a Strad, but not just a violin please! BIEL will be a winner for longs.
Chado - think you may be incorrect on the .0005, who knows when things are so manipulated by unregulated MM's.
I think you are correct on the 10 bagger - BUT - I feel that will happen 3 times.
First pop when FDA actually creates the proposed category to house BIEL's products for OTC sales;
Second pop when BIEL applies into the new device category; and
Third a huge pop if, as and when the FDA approves the application.
We just went from .0002 to .0084 on the FDA announcing its intention to 'create' a new category. No one can predict exactly what's ahead but my bet is that it will be better than what we just saw. We are the biggest user of medical aids on the globe, so along with our disposable income, what is the math? Interested in your opinion.
The advantages, to us as shareholders, of BIEL products over the TENS system are numerous, in addition to the different technology.
* Biggest of course is that it is a consumable!
* Easy to put on the target - no tape
* BIEL's ALLAY will help "tens" of million of women with the scourge of menstrual cramps and pain, month after month after month!
Another release on the FDA approved Belgian migraine band.
Read the study numbers - 1st study 57 users and separate study 53% of 2313 patients were satisfied and would purchase it. I believe this goes a long way toward substantiating my point - it's how you go about things and how you interact with people!
Don't know yet if its Rx or OTC but it talks about patients purchasing it, so is that a clue?
WASHINGTON - The Food and Drug Administration said Tuesday it approved a nerve-stimulating headband as the first medical device to prevent migraine headaches.
Agency officials said the device provides a new option for patients who cannot tolerate migraine medications.
The Cefaly device is a battery-powered plastic band worn across the forehead. Using an adhesive electrode, the band emits a low electrical current to stimulate nerves associated with migraine pain. Users may feel a tingling sensation on the skin where the electrode is applied. The device is designed to be used no more than 20 minutes a day by patients 18 years and older.
A 67-person study reviewed by the FDA showed patients using the device experienced fewer migraines per month than patients using a placebo device. The Cefaly headband did not completely eliminate migraine headaches or reduce the intensity of migraines that occurred.
About 53 per cent of 2,313 patients in a separate study said they were satisfied with the device and were willing to purchase it for future use.
No serious adverse events were connected with the device.
Cephaly is manufactured by Cephaly Technology of Belgium.
I browsed the site as you requested - somewhat vague, which is not to say a bad thing at all, but it appears to be professional and solicits contact.
How about 'Semper Fi" - Always faithful to mission, comrades, Corps and country - no matter what!
When the motto was defined in 1883, it should have included shareholders - perhaps it did!
I happen to believe in the other motto followed by Marine Corps Officers, learned by all those attending USMC OCS - 'Ductos Exemplo' - to lead by example. My research did not reveal that Whelan went through OCS, but these two mottos both apply as character commitments for life for Marines during their time in the Corps and during their lives thereafter as civilians. Just more food for thought. . . .
Thanks very much for your kind words yankee;
If BIEL could establish relationships with the likes of Alan Green and (Dr.) Lee Simon, or others actively engaged in the FDA process, it would be costly but in my opinion an absolute must - executive priority number one!
I leave it to others with more time and current channels to communicate advice to Whelan, Paul and their colleagues - those channels are obviously open . . . . .
The question becomes on of finances - would Whelan be prepared to compensate such players appropriately? For any doubters, I assure all that I am not involved in that space in any way and am not conflicted.
Tks bieliever - nice to see many of the good guys pop out and comment. Time for common sense to prevail. The others are there, I know, Casper, Imrich, stock and the rest. He may not read it but perhaps someone will suggest he read all our posts - he once said he doesn't read such things, but only a fool doesn't change his mind . . .
Few posts in one as comments back. . . .
To Yankee55 - yes, as I have written before, hire the best available to guide the process. I think of great people like Alan M. Green of Cambridge Mass, let's see, BS in Economics, and a PhD both from MIT, Medical Doctor and Lawyer - operates a firm in Boston and his website is FDARegs.com. Kind of has a nice ring to it, no? Now, one of Alan's great friends is Lee Simon. Lee is a former Division Director Analgesic, Antiinflammatory, Ophthalmologic Drug Products Division at FDA - that would be 'PAIN' - he is all over pain. His CV runs 40 pages or so, I have a copy. If I were CEO of BIEL, I would call Alan, he's a wonderful fellow, and chat about opportunities. Talk about a block of stock and the opportunity and hope there is synergy in personalities. Between these to professionals, they have forgotten more about the FDA than everyone at BIEL will ever know in 3 lifetimes. From first-hand experience, they are both decent, fair and love a challenge. . . .
To Ebdi46 - I can not imagine Whelan would blow another tire on this - he stands to make, or lose, many tens of millions of dollars, but also to see his baby make it to the top of the mountain . . . .
To diarch - as the Sultan of Swat would say, "it's easier to slide on BS than it is on cinders" - Whelan needs to get pros in here and I'm not sure the new Exec VP in London is the one to nurse this through the FDA processes. His credentials are solid, I guess the deal was inked in London last week, but his knowledge of medicine may be key to persuading Whelan to ramp up the regulatory horsepower.
To sausage - I don't even want him up to bat - as president he should send in a pinch hitter, even if he has to give away a huge piece of his holdings to get a winner - if he loses again, he has nothing! Bunt?, I want to see Mr. October!
To the fuj - no question he must do it right and from the beginning of the FDA process. Seems to me that if he embarks on this next journey professionally, rather that on a shoestring carrying the representation ball mostly himself which resulted in confrontation, the FDA, instead of thinking, "we bit him back and kicked him out, what's he got for us this time", will be faced with pros, science, data and facts with a new climate - they can only say to themselves, "this guy blundered in here, wouldn't listen, defied our Regs and we threw him out with a cease and desist letter - BUT, to his credit,he listened, he learned, he may even have apologized, he survived and now he's back with a first class application and a team of Pros, wow!" The FDA execs and staff will know, and feel, they were instrumental in the successful process of BIEL redeeming itself and they were. Seems powerful to me. . .
just food for thought
My pleasure and thanks for your gracious message - communication as it ought to be. Wish I could say a lot more, not appropriate at this time . . . .
suggest a review of the link below - read the 3rd point carefully - then go to 'International Dimension' under 'About Us' header and review the map of the Boots penetration and scope of influence - immense.
http://www.allianceboots.com/about-us/group-profile.aspx
Thanks mad - I understand better now my friend. Fasten your seatbelt, need to tell you a bit of a story you deserve to know!
I too did extensive homework, long after I knew from experience that ActiPatch works amazingly well and for 3 reasons:
1. because I wanted to know why the share price dropped so dramatically;
2. Manhattan is not so far from Maryland, I'm a business executive, and I too was in the military, so getting intel on Whelan was relatively easy; and
3. It was a challenge.
Put simply, my intel revealed that Whelan picced off the wrong people. You NEVER picc off City Hall - NEVER! Can we imagine anything more asinine than throwing your weight around with the very people from whom you are trying to elicit regulatory approval? I can't. I spent my own time and money in discussions with a number of FDA specialists, people with substantial scientific knowledge, law degrees and MBA's who are expert at nursing applications through the FDA processes for branded and non-branded products. Afterwards, Whelan's language with you was nothing compared to mine at his imprudence.
He blew the FDA opportunity, in my opinion, because he simply lacks a tactical, diplomatic capability when negotiating. So often the regulatory process is more about avoiding getting "no" then being deserving of a "yes". Combined with all this, he did not have the funds to retain the best stewards of his application; the advice he did get was marginal; and without the knowledge and wisdom to discern the best routes to success, he tried to ram-rod it. The folks at the FDA are well versed in listening to highly professional, smooth, well documented, science-backed presentations, not people who push and demand approval 'now' because they know they are right, or rebut questions with irritability and frustration, as was the case. You don't 'tell' the FDA, you ask, listen and amend, always avoiding getting a 'no'.
Whelan is a pushy, somewhat inflexible, Irish, ex-marine, a little elderly now, with a sometimes appalling attitude that tends to alienate people, particularly when people disagree with him. My assessment is that he received a major psychological blow by the FDA in a major shot to his 'I can do anything, 'I can fix anything', 'I know I'm right' ego.
But, here's the good news - he was right. As I've often said, BIEL products are amazing, patented and a solution for the global scourge of mankind drugging itself. He simply picced off the wrong people when they told him his science and data weren't complete enough. He should have asked politely what he needed to do to comply and thanked them. Instead, we know what happened.
And, to Whelan's credit, he listened, he's still here, the FDA recognized it needed to create a new category, is doing so and it is likely that BIEL will receive OTC approval if the process is handled both professionally and diplomatically.
By the way, it is highly likely that I spoke at least twice with your birdie. I won't say more, now, mad, but I certainly can. Bottom line is that because of all this I am quite bullish on BIEL's probability of succeeding and I am constantly amazed at Whelan's good fortune in now receiving a second chance at FDA approval. He is very intelligent and given that he was kicked in the head once, he won't make that same mistake again.
You're right Pollux - thanks for correcting me. Every long is better off by the price and the news. There is work to be done and it damn well better be done right this time! If so, BIEL has a very bright future. Don't think anyone can argue with the logic.
I asked a year or so ago what prices people here could foresee. That was a dumb question on my part, without regulatory approval and a reliable sales history, it's a total guessing game.
Now with the new device class, I will predict much, much higher - .10? .25? More? Wish I knew. So, it's more and more questions of when and how much, rather than 'if', providing this thing can be managed better and it seems to me Whelan has some experts on board who will handle the FDA application this time around.
And up 1000% from where it was 2 weeks ago.
The dips don't matter - the only issues are:
1. FDA is creating a new class for OTC sales of devices, May 2014;
2. BIEL product line will fit into that new class;
3. The date BIEL applies, the price will rise again dramatically;
4. If approved, (90 to 120 days??)price will rise dramatically;
5. Drug-free, side-effect free pain management; and
6. Approved for OTC sales most everywhere in free world.
and bought 26 Million too!
So, you've actually met him mad?
Hey Imrich
We all know management was inept in several areas, heard it all, all the time.
But, since the FDA has proposed creating a new device category which it appears BIEL's devices will fit into, does that not say that, regardless of BIEL management good or bad, the company had zero opportunity of moving forward at all toward FDA OTC approval of its product for sales here in the US?
If that logic holds, then it doesn't matter what went before, the important thing is what process management triggers now.
And, if my logic does not hold, then how would it be explained that no device firm in the same product space as BIEL, its competitors, had any opportunity for FDA approval for their product either? Could it be explained that all companies in the BIEL product space were inept and that failure to obtain FDA approval was a result of poor management? That logic doesn't hold my friend.
Conclusion? If BIEL had the finest management group in the world in the world, it would still have been trying to push water uphill. If P&G or J&J had the product line, I'll concede that money would have got us to where we are sooner, but the FDA would still have had to propose the new product space. We are where we are and I cannot imagine that BIEL and Whelan would stumble around this time, as before. I don't 'know' that, I just can't imagine it happening again. I think myy logic here holds.
In my opinion, to have BIEL products listed with Boots, with its stores and important wholesale distribution network which buys, warehouses and distributes inventory to thousands of non-Boots drug stores and specialty retail units in the EU is far bigger than any one night prize. Yes, nice icing on the cake, but Boots is huge! It is so significant that other large chains will take a significant look because of Boots. Can't figure out Canada but I'm confident Walgreens will be assessing if BIEL can get an FDA green light here.
What bitterness card? I did not throw a bitterness card, read it again, I prefaced the reference to bitterness with "if" and followed it with a compliment.
It would appear that the "so many" is not enough to stop the dilution yet. Who knows what the Boots deal is as well?
With a population of approx. 64 Million in the UK and approx. 54 Million in England, it is < 1/6th that of the US, the potential gorilla for BIEL sales. I feel once word of mouth spreads in the UK and with Boots coverage of those markets BIEL will have a profitable market niche. We need to give it time. It can't come soon enough for me but I must be patient as there is not a damn thing I can do about it!
Thank you rocker - I am aware of fuente's unfortunate sale.
But, both he and Imrich are pretty bright and they know what BIEL has in terms of potential. The issue is can and will BIEL reap the rewards of the potential. My sense is that if fuente sees even a glimmer of improvement in the quality of management he will buy shares again as Imrich has. If fuente had bitterly written off the loss and gone away to lick his wounds he would not be posting here in such positive terms. I say give him space, he took a serious hit, but he's smart. Thanks again for the reminder.
C'mon fuente - I know you are a little bitter at the lack of management strength and financial performance, but Whelan did put his you know whats up on the table and risked his money, time and effort to succeed. He's still there, still has a substantial stake in the success of BIEL and so what if he erred, if he succeeds we all win.
I'm just as picced as anyone, but I'm not bitter in the least. It's a new day at BIEL with the FDA proposing a new category, how often has that happened in recent years, a new category? Give it a chance and we should all be fair, that's my take.
Questions are:
1. Does BIEL have valid patents on drug-free, side-effect free pain management devices?
2. Is BIEL in a better space than 6 months ago?
3. Does it appear that Whelan has involved science and device professionals in the processes necessary for BIEL to apply for and obtain FDA approval for selling its products OTC in the US?
4. Will such approval cause the share price to rise?
5. Are BIEL products approved for OTC in other western countries?
I suspect Whelan knows he has received a second chance to do it right and will not get a third.
agreed fuente - I was merely trying to suggest Horus do his/her own DD. No question the science and application have to be substantially re-worked to address thing properly.
At the time of the application in 2009 I suggest BIEL management was flying on a wing and a prayer without knowing the science and processes necessary to obtain FDA approval. I have faith now that the scientists on board now will pilot the next application more professionally with the desired results.
With respect to my use of the word 'slide' I was implying that the creation of the new category by the FDA allows BIEL to slide into an apt it BIEL would remain without a category to apply under.
I think we are on the same page.
With the greatest of respect Horus - BIEL had applied for approval for sales OTC and approval was denied. That evidence is available to you as part of your DD.
The fabulous position BIEL is now in, by comparison, is that the FDA has created a 'new' device category that BIEL can apparently slide into.
Cudos to the FDA for creating this category for any company applying for approval for a drug-free product. BIEL's products are also side-effect free and patented, does it get any better?
Also, I don't think anyone is arguing - a lot happened in 2009 and the price went from .004 to over 12 cents on the 'assumption' that applying for approval was approval. At the time BIEL's application was flawed, the data was incomplete, management handled the issues poorly and there was no category for its products, all leading to denial.
Now, the great opportunity is very clear to those in the know - there is now a new category for BIEL products created by the FDA itself and hopefully to be implemented in a couple of months; BIEL is ready to resubmit an application for approval of its products for OTC sales in the US; BIEL has expanded its product line; it's still drug-free and side-effect free and it is believed that management now has the necessary horsepower to move forward with experts involved.
You're welcome rich - glad to be pat of the renaissance, albeit a small one. My advantage was the sprained ankle a few years ago, my Doc was sure it was broken - he still talks about ActiPatch and what it did, so seeing and feeling is believing. I just never thought the FDA was deliberately trying to torpedo BIEL or that Whelan was so inept as to destroy BIEL.
You may recall me writing a year or more ago about the FDA somehow finding a way to save face, I believe we're seeing that happening. On the other side, Whelan was actively selling his wares in the US without Reg approval and got justly nailed for it with a cease and desist letter.
Now, FDA has published its wish to create a new category in which to house BIEL and other companies devices. Whelan seems to be involving others in forging ahead - Gro-International, now with several skus in Boots in the UK. Face-saving over, go BIEL, go FDA, go 510K - patented, drug-free, side-effect free pain management? US based innovation - Disruptive technology!
Hey Casper - I'm delighted ImRich is back and hope I was a tiny, friendly part of persuading him - he's a great asset to us all, but I liked him better when he wasn't so picced off with Whelan. I moved on from being in that space when Whelan started to realize he had screwed things up, but credit to the guy, he stayed the course and must have learned from his mistakes. I'm not saying the leopard has changed his spots, there are many idiots and scoundrels at the top of thousands of companies, but we are on a better path now. Great to see you ImRich
I hear you Chado - thanks
My point was also that I did not know of this meeting upcoming or the horsepower of the medical people attending and or speaking - did you? If not, then I respectfully suggest this is new info to us both.
I know BIEL has been promoting its products, but the flavor I picked up is that this is the first major public meeting/seminar on US soil after the FDA announcement of a new category, a drug-free category, to allow BIEL to apply for OTC approval in the new space.
Chado - how can the PR not really be news? madp is right - it is a huge PR - BIEL is not selling ActiPatch in the US, but the technology, BIEL and the ActiPatch are now all being actively and publicly 'promoted' right here in the US. This is a major step forward in my opinion, the medical community and an olympic team Doc promoting? Because it's drug-free, side-effect free pain management. Huge.
Hey Hunter - you say you picked up another 100,000 yesterday - is that shares, which would be $500, or dollars which would be a good sized trade of 20 million shares or so? If so, I expect you will do well given where BIEL is positioned now. Well done!
Do we all recall it was ImRich who predicted over a year ago that BIEL would be 20 cents last summer - from a very articulate guy who works in the pharma industry somewhere? Understands the approval processes and how inept BIEL was in the early days. So what if he was out on his timing by half a year, or so, very few of us are sprinters here - my point is if he had said BIEL 'should be 20 cents but I'm not sure of the timing' he wouldn't have been abused by Mr. "The ship is sinking" for 3 months to the point where he left. The rest of us lost when he exited. We all pulled back on posting rather then be abused. I hope ImRich quietly got back in, he is missed here because he knows the ins and outs of the approval process - he works in it and deserves to be rewarded for what he brought here!
Don't wake him up, he's dreaming of being long 100Million shares.
I think all the long longs are on the same calm page knowing what BIEL has - forgot to mention patented when I wrote drug-free, side-effect free pain management and not just muscles and skeletal but to help women through menstrual cycles, month after month after month. Imagine the costs in lost productivity and quality of life. . . . I can't. My fingers are crossed that management simply consults with experts every step of the way to get it right. I would like to hear what our friend ImRich thinks on regulatory approval c'mon IRB get in here.