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went to > $ .12 in 2009 (?) on relatively little news, mostly hype - FDA approval would be a different story, but company has to go thru the journey first. Whoever would have guessed that the FDA would wrongly classify ALLAY recently?
Get the diplomats heavily involved rather than the logical business executives, so the FDA decision makers and their bosses can save face - key issue. There's gonna be a hero here, a Senator, or an Inspector General, or an FDA executive, but allow whoever is responsible for the snafu to save face and let's get on with the obvious.
J&J or P&G would already have their approvals and to be totally unbiased, would have done a first class job on the applications and follow-ups, and "A" Team legal counsel and very, very deep pockets, they can afford those, BIEL is a tiny company and cannot.
However, I also suspect that the FDA staff members are people just like us and would love to see a tiny winner soar to success, providing the products are safe and pass muster. Enough noise by the American people, in DC and at FDA and BIEL's products will be approved.
Ha - the trailer side-effect qualifier for an ActiPatch TV ad would be pretty cool - "Safe,no side-effects!" 2 seconds, how refreshing would that be?
15 second ad would be a 15 second ad - no listing 40 side-effects and don't do this or that = less revenue for networks.....
Hey Super - I suspect Canada is under the same drug cartel - every major drug company operates in Canada as well and are household names. Maybe Health Canada simply 'gets it' and the FDA missed it?. What a shame and very embarrassing, one would think, if you're the head of the FDA. The Inspector General must be going, "huh?".
I still suspect understaffing - what was it the FDA recently said as an explanation for many of its internal issues? Something like, "They are the result of turnover and we have to tighten thing up?" Sounded like money issues to me. It is both unbelievable and unacceptable. FDA must have the necessary budget to hire the best and right talent to get the job done - FDA is too important to all of us.
Thanks Casper - My goodness - Canadian Wound Assoc says chronic wounds average 165 days and $10,376 to healing? My badly sprained ankle was amazingly healed and I was walking comfortably in 2-3 days. Returned borrowed crutches to my doc and he couldn't believe it until I showed him the ActiPatch.
Jeremy Irons movie quote for 3 sure ways to success on Wall Street - "Be first; be smart or cheat". What is wrong with us - Health Canada approves RecoveryRX for OTC sales? C'mon FDA - wake up please. Canada beat us and we are still in the starting blocks. No excuse for this. We're late!
Assume 100 million diabetics here in the US and tens of millions more with bedsores or in-grown toenails etc., etc. Would BIEL products not save many hundreds of millions of $$ and avoid much needless suffering?
"Don't Drug It - Patch It!"
"Tylenol who? AcemaActiPatchophen is working wonders"
I declare ownership rights over these phrases. :)
Have a great weekend all Bielievers.
Hey Super - wanting it to "shoot up" is a little agressive don't you think?
I would prefer it to attain some stability at around 25 cents, then continue to rise a couple of cents every couple of days from there.....
There's a tiny rule of thumb about good minds thinking up new ideas - do not tell friends and family of your idea and do not post it on public forums because someone could seek a ruling down the road that the good idea was already in the public domain and therefor not a candidate for protection at USPTO - just trying to be helpful.
Thank Super - The Casper made me do it :)
On your thoughts - My sense is that BIEL should strike the deal with Shoppers #1, or The Katz Group #2, as they are the heavy hitters in retail pharma in Canada - but, not do the deal giving up whatever cut of the profits they can - these retailers are very smart and tactical - they live off their suppliers and cannot risk hurting them. Walmart, on the other hand, has impugned thousands of sources over the years by pounding them into the ground financially.
It is very easy to say, "No one had a gun to the source's heads, they didin't have to do business with Walmart". However, the truth is that often beleagered CEOs of sources big and small do what look like crummy deals just to stay in business obtain bank financing, put newer or bigger hi-speed production lines into play, ward off creditors, or whatever.
Also, Buyers love salary increases and promotions and too often have sometimes devastating power in ruthlessly negotiating deals with little companies to look good. Officers and directors of large retailers are constantly espousing the philosophy of the importance of sources to the growth and continued success of the Corp. Despite this, many Buyers still continue to pound away until the sources go broke, or the big guy sources the product from knock-off central, the PRc, or elsewhere, and the original source who helped the big guy build the business, or brand, gets the shafteroo. Dicey stuff.
Another few reasons I like BIEL; American company, essentially American product and people doing good for the world instead of blowing something up, yet again. Don't get me wrong, the US is critical to its friends around the world and mankind as a financial ally and as a control mechanism against the many treacherous bad guys, but it would be nice to see FDA pull you know what out of you know where so this company can get where it needs to be to do the good it clearly can do. Anyone holding this technology up is going to look like idiots pretty soon - look at the plethora of indications under study, trial or review.
Just had another thought, BIEL should give samples to the military for all the aches and pains, but not ALLAY, fiesty women in combat is a very good thing. :)
Casper - Happy to comment, oh corpulent one....although there is no need for you to describe yourself as that - perhaps corporate shell might be more appropriate? Look at me a post or two ago - could't spell niece....
A possible way for BIEL & Greenwood to deal with the timidity of Shoppers not wanting to be first, or playing the waiting game to see the Walmart margins, is for BIEL to take a position of leadership - get a Shoppers deal done and give them an exclusive for whatever period of time they are able to negotiate to get the line on the shelves.
There needs to be a real hunger to close the deal. There is no upside in trying to wring the last cent out of deals, if you are not in the game sitting with a warehouse full of aging inventory. Leave something on the table, but get a deal done! Christmas is coming quickly and there is no better stocking stuffer for 2012 than an ActiPatch or an ALLAY.
Just another stupid thought - give the US Olympic Team a supply of ALLAY for its female Olympians and others accompanying the team to the UK - they will be better prepared for competition. Get feedback and use it. Better satill, give em to the Canadian team - BIEL is legal up there. Is this stuff not obvious brain-storming, or am I nuts?
On your being enamored by my level of DD, I am honored. If you only knew. This started with a badly sprained ankle from tennis and a miracle ActiPatch sent o me by a classmate up in Toronto, but, if you only knew :)
Re the last paragrapgh on Shoppers tweaking its Planogram semi-annually, I can't really add a thing, other than I had someone very, very competent place the call for me after learning about the semi-annual Planogram from a supplier to Shoppers. You know what it's like to make quiet calls and call upon corporate friends..... You have all I learned, which categorically refuted the earlier claims or excuses, I know not which, that BIEL products could not be introduced on Shoppers shelves, but once a year.
Hey Ghost - you did try to explain it after you said I was very close to the reality of what has transpired and the players involved. I am now closer still and you did not mess it up at all - you simply mis-spoke when you said/wrote P&G, when it was actually 3M. Water under the bridge, corrected etc.
Looking forward, how long would you estimate it would take to very carefully quantify what progress has been made by Greenwood et al on developing Shoppers Drug Mart with over 1,250 Shoppers and Home Health Care stores and #2 in Canada, The Katz Group with Head Office in Edmonton. Daryl Katz, who built the Rexall empire, operates over 500 corporate pharmacies in Canada and the US and 1,800 retail units total, including franchises, under the banners Rexall, PharmaPlus, Guardian, I.D.A and The Medicine Shoppe Pharmacy. Very successful operation and I know from a US NHL team owner that Daryl Katz is extaordinarily competitive. He owns the Edmonton Oilers and is a very active, hands-on, owner.
If I'm Greenwood, I give Shoppers an opportunity to put BIEL products into its program with a one or two year exclusive in Canada, and while they are looking at BIEL, go and talk to Katz and give Katz a one or two year exclusive in Canada. Make a deal that will put BIEL's product line on the shelves in the pain section and Women's sections, but make it happen.
By the way, the earlier claims, as Gospel, that Shoppers only tweaks it's product lines to include new items annually was incorrect. Shoppers, like every other retailer on earth grabs winners whenever it can. The reality is Shoppers re-creates its Planogram semi-annually. My source? Shoppers buying group in a phone call.
And Fuj, further to my earlier suggestions, I will wager that BIEL has sampled the good Senator with a few dozen ActiPatch for personal use by her and her staff in DC and at home. Imagine the huge impact when a child or nephew/neice or other relative reports back to her that they had very positive results. Send her enough samples that she can spread them around. If just one relative or staff member reports back, that will speak volumes.
With a background in Social Work and being from a family-owned grocery store environment, Barbara Mikulski's feet are firmly on the ground and she's no fool.
On the matter of what BIEL can do, I am not conflicted in any way whatsoever here, but I was involved in an FDA matter a number of years ago and the company I was affiliated with at the Board level used a gentleman very experienced in FDA processes and his fees were quite reasonable. Take a look at FDARegs.com, his name is Allan Green and he is an MD, PhD and JD. I soke with him numerous times and he is down o earth and quite brilliant. No doubt BIEL has highly competent counsel for FDA matters, I am just throwing this up against the wall.
I think Doodles may have been light when he estimated this morning that BIEL was headed for 20 cents today - I'm a seller of some at 35 cents end of next week :)
Way to go Super - OR, contact a few trainers of elite athletes in Canada, give them a few ActiPatches, wait a few weeks then contact a few of the elite in the US, give them a few hundred and tell them they can buy them in Canada.
The worst thing of course is if the British, Kenyan, Etheopian, German, Russian, Chinese or Australian athletes were to learn about ActiPatch and the US athletes are kept in the dark!
Way to go Super - OR, contact a few trainers of elite athletes in Canada, give them a few ActiPatches, wait a few weeks then contact a few of the elite in the US, give them a few hundred and tell them they can buy them in Canada.
The worst thing of course is if the British, Kenyan, Etheopian, German, Russian, Chinese or Australian athletes were to learn about ActiPatch and the US athletes are kept in the dark!
Thanks for the post Reddy. If I were Mr. Whelan, I would donate enough ActiPatches to the US Olypic team to take it through the upcoming Olympics. Let the drug testing folks test all the urine they want - ActiPatch will help with athletic pains and strains. And, while you're at it Mr. Whelan, give them to all the American cyclists in the upcoming Tour de France. Do it in such a way that the products are donated to athletic "clinical trial" your staff design. Have the participants and training staffs monitor and report back to an on-line data base and then release the data to FDA and the media.
Can you imagine medal winners performing at their peaks and bringing home more gold, silver and bronze partly because of ActiPatch. I just thought of athletes in the Decathalon....can you imagine the last 3 events for an exhausted decathlete who had ActiPatch on between events and overnight? It's not a performance enhancing drug now, is it?
I know for a fact that massage, acupuncture, thumpers, Tens - Definition - "a self-operated portable device used to treat chronic pain by sending electrical impulses through electrodes placed over the painful area", Chiropractors are all legit, so make the contacts BIEL and while you're at it, contact the US Equestrian Team to keep those jumpers in the air! ActiPatch is not like Bute, which chemically, falsely masks strains and other injuries to maintain high performance - ActiPatch first deals with pain then accelerates healing and if the horse or athlete is NOT in pain, then he or she is healing! Pain obstructs and slows healing. Make the patient comfortable with chemicals and they heal faster because they are not fighting the pain and no chemicals for the testers. Use ActiPatch and the patient heals even faster! London, here we come! Get on it BIEL - NEW CLINICAL STUDY ON US OLYMPIC ATHLETES, INCLUDING EQUESTRIAN FOLLOWS SUCCESSFUL CLINICAL STUDY AT TOUR DE FRANCE
Hey Dubb - amazing post - thanks very much.
Could this snafu at FDA be as simple as a misunderstanding of the issues and data brought about by inexperience or sophisticaion with respect to the product? When FDA explains that it is having issues with "turnover and budget fluctuations" - what the H are budget fluctuations and how do they affect the talent and expertize pool on devices? That double-speak tells me they ain't got the talent in place to properly assess the widget applications FDA is getting, particularly on PEMF and other devices. These are not drugs, so a different skill-set is required?
How can FDA assess PEMF and new predicate devices if it doesn't have the best and the brightest assessing the technology? PhD's in various disciplines of chemistry cannot do this. Plain and simple.
The acknowledgement that FDA "may need to tighten up some aspects of its approval process" leads me to suggest it stop any approval processes it may have to tighten up, instead of what logic tells me they are doing, which is therefor winging it. If you have to tighten it up, means it is sub-standard = guessing and winging it! And if FDA is winging it on the rejections, it is also winging it on the approvals, which is placing the public in harm's way. So, stop until you have the talent in place and competent.
Imagine the costs of winging it on FDA, applicant companies and the public, please, let's not forget the public which uses or does not use drugs and devices on the say so of a system that needs tightening up?? "May need to tighten up some aspects? Amazing, just amazing..... Time to use the philosophy of Delta Force members - we don't do something over and over until we get it right, we do it over and over until we can't get it wrong!
Stand up and take a bow Casper - no need to apologize whatsoever.
I was delighted to simply give you a little space in our dialogue until you could perhaps go back in your intel and make make the minor corrections. It only made sense, because the flow of your feedback to my curiosity was so specific, it could only have been just a little off, in my opinion.
So, back to your comments that I am very close. May we leave it, for the time being, that a number of business executive acquaintances in senior positions were discussing BIEL and sharing intel and they appropriately used their relationships to further the progress already under way?
I'm also curious as to the most correct way to address the Senator....would it not perhaps be The Honorable Madame Senator? As in Madame Speaker, Madame President, etc.? I am familiar with the definition with an 'e' which is sometimes used as a title of respect for a woman who is not of English or American origin, but I think protocol, as evolved in recent years, 50 or so, now includes ladies of distinction of American origin as well.
After reading the flurry of posts responding to the letter to shareholders, it is very clear to me that (a) the investors are a very articulate group, and (b)the company appropriately consulted with legal counsel very quickly and counsel prepared the letter with them.
Clearly, the letter does not read as Mr. Whelan speaks, as compared to the recent interview. To be fair, I understand speaking 'on your feet', as it were, in an on-air interview, as he was, is far different than having the time to consider a detailed letter carefully, but counsel had a major hand in that letter and will be stickhandling dialogue with the FDA.
Based on my knowledge of another very slight FDA error, I am totally confident that the company will bring in the necessary warriors to deal with the necessary fire-fighting and corrective needs of this matter. It's logical and it's businesslike to do so. And there are warriors out there who specialize in nothing else but the legalities and intricacies of FDA processes and approvals. I asked a senior partner at our lead law firm and that's the answer I got.
Worst case scenario, in my mind, is for ALLAY to initially only get some sort of restrictive approval to get it out in the marketplace to help millions of women suffering from the debillitating pain and cramping of menstruation. Then, once it's out there, the company would apply for other, more liberal, classifications. Will this happen? As a laymen, it doesn't 'feel' to me it will get to the worst-case, multiple step, drawn out process, but what do I know? . My gut tells me FDA reviewers missed something and it will be corrected. I was advised it has happened many times before and will continue to happen, because of the complexities of the work the FDA carries out where often major decisions can turn one way or another on a single word, or miniscule interpretation.
Good post gman - I am very close to a company which received a "no" classification last September/October - the executive group could see instantly and clearly that the reviewers missed something critical and they raised hell through legal and regullatory counsel and after 6 months the FDA reversed.
What the FDA had ruled was a physical and technical impossibility of reasoning - they simply missed it!
It happens folks and it looks as if it just happened again and will most likely be corrected. I'm nt worried, it's part of the tedious process of FDA approvals.
Great intel Jimzin, shad and fuente - I suspect that the silence means Casper the Ghost is verifying some things like the "Ace" reference and the Brand Manager at P&G who did the spreadsheet on the potentially negative effects of BIEL on P&G sales.
I willingly accepted Casper's (Ghost's) message about Ace Banadages and P&G and its contents and if I passed on or used erroneous info, my apologies, but the jury is out - the Ghost is highly credible in my mind and the info in that message seemed very precise, including the portion referring to being close to someone close to the issues....high specificity. He may simply have misspoken as to the product name. Let's wait and see.
However, the Sausage and others are absolutely correct that other large and small potentially concerned manufacturers of devices or drugs could be inserted for P&G.
So, it's a toss-up between the first two of the 3 part formula I mentioned for assured success on Wall Street and in the global financial markets (In the merchant banking and M&A worlds it's gospel by the way) - Be First or Be Smart.....
I say, in the BIEL case: Be First, because the smartest guy in the world is still a loser, if he's second.
Hey Casper - when you suggest P&G can put pouches in their Ace Bandage wraps, I assume you mean to slip in an ActiPatch?
Wouldn't that just make the Brand Manager over at P&G who did the spreadsheet or SWOT work-up on the BIEL threat to their Ace Bandage sales a hero now?
As I have said, someone somewhere should be screaming BIEL as an acquisition target, either to protect sales of existing products, or to grow sales in a medical devices division, or your suggestion of putting pouches in Ace Bandages which would make a cool combination product....
Anyone see what Alex Gorsky said in a Bloomberg interview on April 26 - his first day in office and first interview since being appointed CEO at J&J? Here it is in part - note the comment about medical devices. Yessssssssssss
HEADLINE
J&J CEO Gorsky Says Company Will Grow While Rivals Shrink
By Shannon Pettypiece and Michelle Fay Cortez - Apr 26, 2012 7:31 PM ET
When Alex Gorsky takes over as Johnson & Johnson (JNJ)’s chief executive officer today, he won’t be shedding operations like his peers at Pfizer Inc. (PFE) and Abbott Laboratories. (ABT) He’s looking to get bigger.
Gorsky sees value in being a large, diversified company and said he has no plans to sell any of J&J’s businesses. He expects to use some of company’s $14 billion in cash to do deals, focusing on medical devices such as heart valves and acquisitions that will expand sales in China and other emerging markets, he said.
“When there are large opportunities that we think can give us some strategic advantage, we will obviously take a look,” Gorsky, 51, said in a telephone interview. “We are committed to being diversified across the whole health-care continuum.”
Gorsky will officially takes over as CEO today of the world’s second-largest seller of health-care products during the New Brunswick, New Jersey-based company’s annual meeting. He steps into the role as J&J’s image has been tarnished by recalls of artificial hips and over-the-counter drugs; safety concerns over its vaginal mesh products that spurred hundreds of lawsuits; and more than $1.1 billion in fines over the marketing of schizophrenia treatment Risperdal.
The interview yesterday represents Gorsky’s first public comments since he was named CEO in February, replacing William Weldon, who ran the company since 2002.END OF THIS PART
Annnnd here's the best art for BIEL investors.
For J&J to acquire BIEL would mean that J&J just hammered a nail in the P&G Ace Bandage coffin.
For P&G to acquire BIEL would mean that P&G just hammered a nail in the J&J Tylenol coffin.
For anyone else in the pain market to acquire BIEL would mean that entity just hammered millions of $$ nails $$ in the J&J Tylenol and P&G Ace Bandage coffins and every other pain treatment coffin in the market.
As Jeremy Irons said in 'Margin Call' about the 3 ways how to survive and succeed on Wall Street and in the global financial world - "Be first, be smart or cheat." Taking cheating out of the equation, this should be interesting to watch, given that an advisory committee inside the FDA recommended somehow controlling acetaminophen because of epidemic liver damage from over-use....
Great work Fuj - keep pestering them - They cannot and will not say more - even if a human saw your message - they have a business position to protect - one of the earliest posts I put up as a newboy moron, having had a horribly sprained ankle that ActiPatch healed up unbelievably was kind of a "what if" - what if J&J bought BIEL? I think I said something like - I would not want to be the guy in the hot seat when BIEL gets its FDA approval or a J&J competitor bought BIEL and Tylenol retail and hospital sales take it you-know-where? I raved on, something about - "Can you imagine the board of directors asking all the right questions? Like - what the H were you guys doing other than sleeping?" Now I'm totally convinced many heads would roll because those heads are paid to avoid trouble and not just at J&j, but throughtout the pain market.
Then, I wondered who was running J&j and noted thru google that Alex Gorsky had just been appointed as new CEO at J&J, and assembled and posted - that he had been promoted to CEO from Director of the J&J device division, with the BIEL potential and the effect on Tylenol sales when BIEL gets its FDA approval.
All pure stumbles one would think, but my stumbling, along with other good folks here, was just assembling logic. Months ago, hypothesizing the anger of J&J directors that BIEL pulled the rug out from under the Tylenol market was kind of comical rhetoric and then Alex Gorsky - BAM. And now, if I'm Alex Gorsky, and knowing that P&G was/is concenred about losing major market share in Ace Banadages to BIEL, then I'm all over BIEL to make a deal. And if I'm not Alex Gorsky, but a lowly brand manager, I'm pounding on Alex's door sceaming, "BIEL"!!!! It's just logic.
For any of these guys to buy BIEL and absorb it as a device into their existing business would be a rounding number on their balance sheets. To not acquire BIEL is a huge hit on their sales.
For those connected to these industries, this is easy stuff. For simple investors with real lives working elsewhere, it's not so easy. Thanks again Casper - you have done a real service to investors by providing clarity.
Thanks Casper - and to think I got this close with no relationships. Guess I'm not as naiive as I thought.
Hi Disciple - we need to encourage Ghost to give up the ghost and reveal all....
From the Patrick O’Leary Bio on the www.rpm-llc.net/OurTeam.htm web page, we see an AVR plug, then right after it, a Greenwood plug.......
“At Advanced Vision Research, where he has been in the role of Brand Manager since 2001, he serves as a member of the management team and assists in strategic planning, sales, marketing, co-branded initiatives, and new product development. Since joining the AVR team in 2001, TheraTears has tripled in sales.
Greenwood Group builds businesses!
The Greenwood Group team has over 280 years of collective experience in the CPG industry.
With backgrounds from the Fortune 100, as well as entrepreneurial endeavors, you will find a blend of talent that allows any manufacturer to look and act like a “big” company while being able to take advantage of the flexibility available to a smaller company. END
And, from www.greenwoodg.com:
“At Greenwood Group, we provide focus to both emerging and established companies. We develop and implement strategies that improve profitability – through increased sales and decreased costs.
With over 400 combined years in the CPG industry, Greenwood Group's sales, marketing, sourcing and logistics capabilities allow any company to operate with the cost efficiencies of a Fortune 500 organization, while maintaining entrepreneurial flexibility. END
Observation - I guess the rpm website mentioned 280 years of collective experience in the CPG industry first. Then at a later date Greenwood’s years of “combined years in the CPG industry” jumped 120 years when Mr. Donnenfeld joined Greenwood as a partner, but requested that his name not be shown as a partner because he wanted to be like Mr. O’Leary who asked that his name not be shown as president? Huh? There may have been other additions, but 120 years is a long time and Donnenfeld is around 50!
The rpm website states about O’Leary - “At Advanced Vision Research, where he has been in the role of Brand Manager since 2001, he serves as…..and assists….”. These duties are stated in the present tense. AVR is at 7 Alfred St in Woburn, Mass, a long way from his president’s chair at Greenwood in Cheektowaga in western NY. AVR was sold to Akorn in May 2011 – 12 months ago……
Now, it gets a little interesting. We know O’Leary worked at P&G and AVR and president of Greenwood representing BIEL….
February, 2010 - Swampscott — Neil D. Donnenfeld of Swampscott has been named chief executive officer of Advanced Vision Research of Woburn, makers of the TheraTears and MacuTrition brands for dry eye and macular degeneration. He was also named as a director of the company.
Donnenfeld has extensive experience with Advanced Vision Research and has been instrumental in its growth. He most recently served as the company’s senior vice president of global sales and marketing, a position he held since 2005.
Donnenfeld, 48, joined AVR in May 1998, shortly after Advanced Vision Research was originally formed as an over-the-counter eye care company to market and distribute TheraTears products.
Advanced Vision Research continues to rebound after the sudden loss of Jeffrey P. Gilbard, MD, the company’s founder, CEO and chief scientific officer last August.
Noted Donnenfeld, “I’m honored to have been chosen as the new CEO of Advanced Vision Research where we are dedicated to continuing the path blazed by Dr. Gilbard. We are eager to introduce revolutionary new products that are already in the pipeline, and look forward to the development of new advances in eye care treatment that improve patients’ lives.”
Donnenfeld has been involved in most aspects of building Advanced Vision Research and its brand portfolio and has maintained close connections with the professional community that forms the base of TheraTears and MacuTrition’s loyal advocates, including optometrists and ophthalmologists.
Most notably, as the senior sales and marketing executive for the OTC business, Donnenfeld spearheaded 12 consecutive years of record sales and profitability for the company. Advanced Vision Research was recognized three times by INC magazine as one of the fastest growing privately held companies in America and by Drug Store News as one of the top niche brands for the past four years.
Prior to joining Advanced Vision Research, Donnenfeld was director of marketing at NutraMax Products, a leader in private label health and beauty care. Before that he managed the Bain de Soleil Suncare Brand at Procter and Gamble and worked on other P & G brands including Dramamine, Icy Hot, Clearasil and Oil of Olay. END
Then, on May 3 2011, 15 months after Donnenfeld is appointed CEO at AVR, this announcement….
LAKE FOREST, IL- May 3, 2011 -- Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, announced today that it has entered into an agreement to acquire Woburn, MA, based Advanced Vision Research, Inc. ("AVR"), a premier over-the-counter ("OTC") ophthalmic company that develops and markets eye care products under the TheraTears® and MacuTrition ® brand names, for $26 million in cash on hand. These products are used for dry eyes, eyelid hygiene, contact lens comfort and eye nutrition. AVR was founded in 1995 by the late Jeffery P. Gilbard, M.D. with its lead products developed in the clinics and laboratories of Harvard University's Schepens Eye Research Institute. In 2010, AVR generated sales of $20 million, which consisted of domestic sales through major retail chains and sales in 20 countries across five continents. END
Soooo, we have Donnenfeld at P&G, CEO of AVR in Woburn Mass from Feb 2010 to May 2011; appointed president of Products Ahead 2 months later in July 2011; 6 months later, in Jan 2012, appointed as a Partner at Greenwood Group in Cheektowaga NY representing BIEL. With an MBA from Wharton in marketing, the guy must be good - hope his focus is somewhat on BIEL.
Both O’Leary and Donnenfeld were at P&G, and then both at AVR, Donnenfeld joined in 1998, O’Leary in 2001, where Donnenfeld became president and both were, or are, at Greenwood Group where O’Leary is president and Donnenfeld is a partner. Who’s on first and who is looking after BIEL gentlemen? And, who is Ms. Greenwood and is she related somehow?
Point. The BIEL announcement of Donnenfeld handling the BIEL account states that he took AVR to $45 million, but the Akorn Inc. acquisition announcement states that AVR did $20 million in 2010, the year Donnenfeld was president. The only way Donnenfeld took AVR to $45million was if he more than doubled the previous years sales (2010) in the first 3 months of 2011.
Donnenfeld and O’Leary are at least colleagues and follow one another from company to company. That’s great, but I hope the synergy is working its magic on the BIEL account and the launch in Canada. It would be cool to know if any of these people might be related in any way? I am sure Andy Whelan did this due diligence and knew of the relationships when he signed Greenwood on to handle the BIEL account, but it would be nice to know if the 280 or 400 years of combined Greenwood experience has yielded any results in Canada yet…….
Hey I'mRich, fuente, mad and all the other good people - This is a long post, but you and others may be interested in it and able to clear the possibly muddied waters....
In one of the BIEL investor updates, Jan 5 2012, I noted that a Mr. Neil Donnenfeld had joined the Greenwood Group as a partner and appointed to handle the BIEL account.....
QUOTE
Neil Donnenfeld, partner of Greenwood Group, has been named as our retail Account Manager. Mr.
Donnenfeld has over 23 years of professional experience and a proven track record in sales and
marketing. He previously was the CEO of Advanced Vision Research (TheraTears). In a few years,
Neil made TheraTears a 45 million dollar company. Neil was also the Director of Marketing at
NutraMax Products and a Brand Manager at Procter & Gamble for several years. He holds an MBA in
marketing from University of Pennsylvania - The Wharton School.UNQUOTE
Then, in the Feb 16 update, a few weeks later, the following appeared.....
QUOTE
BioElectronics Andrew Whelan and Patrick O’Leary, President of Greenwood Group, is attending the prestigious European Health Care, Vitamin, Diet & Nutrition Show in Monte Carlo on Feb. 21 -23. The event allows manufacturers of OTC products, such as BIEL, to present their products and programs to Eastern and Western European retailers and distributors from many nations representing numerous different potential sellers of these products.
Greenwood's offices, as we know, are located at 4455 Genesee St., in Cheektowaga, NY, Tel: 716-631-3003 and I recall this was to service the Canadian marketing needs, launches and so on.
Now, since Mr. Donnenfeld was announced in January, I haven't seen his name - have you? I went to the Greenwood site www.Greenwoodg.com and his name is not there - a partner's name is not listed? Then again, neither is Mr. O'Leary's and he is apparently the president? Neither name is listed in a hot linked page entitled "Our Team" on the left side of the "About Us" page.
Googling "Patrick O'Leary" reveals no mention of him related to Greenwood in the first 10 pages of Google. But, Googling "Patrick O'Leary President" pops him up on the www.rpm-llc.net website as follows with a long Greenwood blurb.
QUOTE
Patrick O'Leary - President / Partner / Business Manager of The Greenwood Group
Years in the Retailer / Manufacturer Industry: 26 years
Background:
Bayer, Parkview Health Services, P&G (Gillette), Keystone Organization, Crossmark, Emerson Group
Patrick brings both the formal training of Fortune 100 companies as well as an entrepreneurial spirit from a variety of successful company ownerships.
Working on major brands at Bayer & Gillette, as well as serving on advisory boards for small to mid-size brands as a VP at Crossmark
Applying the basics of consumer research & strategic planning to brand opportunities, while employing non-traditional strategies for marketing and sales, he has actively launched successful brands using a variety of platforms and methods.
As a Partner at Emerson Group, he served as VP of Sales for ZonePerfect Nutrition. Over a nine month period, Patrick re-organized the sales team and then assisted in the transition to a new VP of Sales. His work in that capacity, along with key customer management, allowed the company to grow from $8mm to $80+mm and then be sold to Abbott Labs for $165mm.
At Advanced Vision Research, where he has been in the role of Brand Manager since 2001, he serves as a member of the management team and assists in strategic planning, sales, marketing, co-branded initiatives, and new product development. Since joining the AVR team in 2001, TheraTears has tripled in sales.
Greenwood Group builds businesses!
The Greenwood Group team has over 280 years of collective experience in the CPG industry.
With backgrounds from the Fortune 100, as well as entrepreneurial endeavors, you will find a blend of talent that allows any manufacturer to look and act like a “big” company while being able to take advantage of the flexibility ava ilable to a smaller company.
Up front, we provide an immediate infrastructure to any company and/or product, to develop a strategic plan in preparation for getting to market, or for improving that which is already in-market.
The preliminary planning steps are key to long term success, as are several other factors that are core strengths of the Greenwood Group. From Pre-Market Planning to Education and Marketing, and through to Consumer Adoption and Purchase, we surround the opportunity to bring the best chance for success with the most efficient costs.
In the execution and sell-in phases, we interact with all national and regional customers via live meetings in their corporate offices throughout the year, and at a variety of industry-leading trade events.
We manage all US &20Canadian Food, Drug, Drug Wholesale, Club and Mass customers and other selected classes of trade, via our Sales Managers and a network of market leading brokers.
We closely manage spending and profitability by using a formal series of tools, formats and processes which make our clients, brokers, and us more efficient and more productive.
Our network is consistent throughout the US and has multiple levels. By leveraging our entire portfolio of brands, you get the attention of a much larger company. That attention, plus an accelerated activity-level, increases your brand’s frequency and access with numerous people, including key personnel, within each customer.
In short, we are able to put several people on your business who have:
1.Extensive formal training from some of the best companies in the CPG industry
2.A proven track record of successful entrepreneurial experiences
3.A knowledge and relationship base that is unmatched in our business.
The annual compensation of this type of team, if it were to be directly employed, would be prohibitive to many companies. Rather than hire one or two people and deal with the various issues & costs which that represents, Greenwood takes the guesswork out of the decision and provides more complete services and better execution for your dollar.
By working with us, you can greatly reduce this cost yet still provide a multi-faceted team that can be in many places at once, and accomplish goals through a variety of skill sets.
This “reach” gives you more exposure to the industry, which garners you more attention and opportunity. By focusing on profitability, we insure that the increased visibility works to your advantage.
Our goal for each of our clients is to grow profits through increased sales, decreased costs and improved efficiency.
See RPM/Greenwood for:
•Pre-Market Consulting
•Consumer Marketing
•Strategic Planning
•Full Service Design
•Field Sales Management
•Trade Marketing
•Strategic Raw Materials Sourcing
•Integrated Supply Chain Logistics
UNQUOTE
Questions are simple -
1. How is Mr. Donnenfeld doing?
2. How come he's not listed as a partner on the Greenwood site?
3. Is he still on board at Greenwood?
4. How come Mr. O'Leary isn't listed on the Greenwood team?
5. How come the huge O'Leary/Greenwood blurb on the RPM website and squat on Mr. O'Leary on the Greenwood site?
6. What or Who is RPM and the connection to Greenwood?
7.Is Greenwood still advancing BIEL's interests in Canada?
8. Is there an investor near Buffalo who can do a drive-by or call locally to verify that Greenwood does represent BIEL and wish them luck?
Seems very local - probably North and South Islands only - they may also be picking up business in other parts of Australasia, mostly New South Wales, if they are promoting in papers there, but shipping costs to the US and EU would be a killer.
I also tried a .com and a .com.au website and came up empty
I would love to see reason for disallowing or rejecting BIEL's applications for PEMF OTC approvals:
Hmmmm, let's see.....top 10 reasons....
1. The EU approved it first, so we won't, cause we're #1?
2. Then Canada approved it for OTC sales, so even more reason cause we hate being last
3. Some doodler has stated that BIEL is going BK
4. BIEL is late on Canada launch, don't know why, but they are
5. Doodler states CEO was vacationing in Dubai on company expense
6. That would be a cool reason for FDA rejection, except who vacations in Dubai and posts pictures attending a conference??
7. BIEL's products are patented and that will keep the big pharma boys out.
8. BIEL did a deal with China and we don't like that either
9. BIEL is attempting to develop its business internationally while they're supposed to be waiting for us to approve their applicaions for the US
10. Can't think of one, so let's not approve it and we'll make it up as we go.
Since there has never been one negative side-effect from PEMF that I can find on the internet and since BIEL already has Rx approval for RecoveryRx for post-op eye treatment (that would be near the brain), how can the FDA not approve the applications by BIEL?
Come on doodles - just one reason, please
Hey Jimzin - thanks for the response.
I question whether approval of the PEMF eye device by BIEL was, as you say, "retarded", since it was probably the only application FDA had in front of them at the time? Doesn't this fact make it even more likely BIEL will receive subsequential approvals?
I posted ealier a similar comment to yours; that I found it impressive that the first approval was for the eye post-op and not some other less critical area. I also observed how close they eye is to the brain, which seemed to me to give BIEL's RecoveryRx even more credibility in terms of safety.
Seems to me that FDA is under-staffed and probably under-funded, but they are there to keep us safe. With the RecoveryRX approval already in-hand, I have no doubt BIEL will receive its approvals for the other products. I have asked, but no one has come up with a single reason or side-effect as to why approval should not be issued.
Soooo, is it reasonable to accept that with all the current applications in-process at the FDA by BIEL, is it 8 different products?, that the FDA simply grouped them all together and must go through a full process of assessment and then release a decision also lumping them all together?
Could they have simply decided that since BIEL is into a new area, without predicate data, that they must do a full-blown assessment for an all-encompassing approval?
BIEL's Recovery RX for post-op eye treatment is one thing, but for OTC sales like ActiPatch and ALLAY and the other apps, are they new territory? I'm confused as to why the earlier approval BIEL has would not apply to the new applications??
Hey Fuente
Noticed on FDA website listing Medical devices approvals in 2012 that there were 5 approvals in January, 9 in Feb, 3 in March and 4 in April.
Do you know if the low numbers are because of staffing issues at FDA? I assume the politicians can screw with the FDA budgets as they do all others, but this few approvals smells of overworked staff members. Also, is there any way to determine the backlog of issues, reviews or applications in-process at FDA?
Thanks
Here's exactly what Whelan the CEO said in the interview....
"We have what I describe as a Disruptive Pricing Strategy, we set the pricing, we're half the cost of Tylenol. We're not leaving any room for Johnson & Johnson, or ***lectronics (?), or any of the big guys to come in and figure out how to beat us on price - we have our price set, we have good margins, we're gonna (stutter)...., it's our market and we're not sharing."
My observation this time is there is a small chip on his shoulder on this, with a somewhat aggressive lift in his voice, as he found his words at the end after the stutter - why? It may simply be a competitive attitude from a CEO, which is good, but the stutter and last comment tells me there may be more to this.
Were there discussion with other companies? Did his advisors suggest he should enter into such discussions and he stubbornly refuses to do so? Are we perhaps dealing with a touch of the 'Inventors Syndrome' or inventors ego here? This is my baby and I'm gonna make it fly? Was this man offered a smaller piece of a bigger pie and ego is getting in the way? My nose is twitchng.....
Then, when he tells the story following this, the technical aspects and indications of BIEL seem to make it much more than a simple pain treatment competing with Tylenol - wound healing, healing, feet with plantar fasciitis, dental and TMJ, ankle - achilles tendons. etc., etc. He also talks about 11% of clinics in the UK using PEMF technology and then the specific words, "when we get US clearnce". He doesn't say "if" or "if we ever" or anything else - he says "when". That's pretty positive.
He talks about SUDA (sp?) the largest health group in the UK, which also has a group organized of 55 OTC distributors around the world covering 400,000 pharmacies. He says they spoke to the distributor group last year and are working on getting the products out to those pharmacies. Then he goes to different products and indications. Good interview IMO.
Good question Speak, but are the BIEL products not protected by patent? Could the comment by Whelan have been related to BIEL sharing its IP? hmmmm - "We're not sharing" I have to hear it again. Later.
p.s. just found the link, I think.
http://gaskinsco.com/biel-c.mp3
You ain't the dullest knife in the drawer Casper - never thought of Merck and Dr. Scholl's, like, isn't Dr. Scholl's global?
My thinking only went to my question a few days ago about all the other companies manufacturing acetaminophen products for simple pain relief, not just J&J. The shelves at Walgreens and other chains are full of them, private labels everywhere. I was too focused on Tylenol.
Add to the pain relief of ALLAY and ActiPatch the ActiPatch news of actual acceleration of healing soft tissue damage and now the study out of Chicago about enhancing bone regeneration, one must wonder if we have a monster in our midst here.
What say you Doodles? Give us your detailed opinions on the technical aspects of the efficacy of BIEL products on the numerous indications studied thus far. Please.
touch of humor on a Friday .....
Ghost struttin the BIEL colors - investor-dis ...and investor-dat
:)
Just catching up here Casper but I agree with what you say. I would never ask a CEO to predict when he thought he was going to get FDA approval on a product, under the assumption that he would look at me as if I'd just asked the most stupid question on earth.
The most truthful answer could only be, "I have no idea you moron; when I know, you'll know." Anything else would be pure speculation, with a conflicted tinge or blatant dose of hope - ergo - I'm hoping soon! So why ask the question at all?
clearly
But if we turn it around, is this not a classic case of 'no news is good news'? Would BIEL not have regulatory obligations to release news of any adverse rulings or rejections by the FDA? If so, I venture to say that since we've heard nothing, therefor we're alive and well at the FDA and in-process. And the CEO saying "soon" regarding approval on 8 products means, to any reasonable person, that he has not received rejection notices from the FDA, or whatever they do in such cases. Seems to me this guy is still in the game fighting for approvals.
Just another thought. I'm not an FDA type guy, maybe you, ImRich or Fuente can answer this, but could the FDA rule that it won't give BIEL the applied for OTC clearance for the 8 products but it will give this or that type of more limited approval instead? And if so, would that not also be great for the company? Perhaps not as good as OTC approval, but still great? I would see that as a triple versus a home run. And would FDA give such limited approval, like Rx, when the rest of the world has given OTC clearance, like civilized and conservative Canada to the north?
Hey disciple - What struck me as very curious in the interview was Whelan's comments about a new pricing policy geared to compete with Tylenol - sort of selling ActiPatch as having twice the efficacy at half the cost of Tylenol. Essentially he was saying that BIEL had set new price points relative to the retail cost of Tylenol and then he went on to say, and it's a few days since I heard it, "and we're not sharing". He said it in a combative tone. How come?
It struck me instantly - 'Huh? Those words 'seemed' very curious.' And my thinking went on to, 'now, why would he say that in an almost combative way, sort of with a chip on his shoulder, almost picking a fight with J&J? The guy sounds as if he may have Irish roots, but who picks a fight with J&J? I would rather partner with them!'. Those were my thoughts at the time I heard the comment.
The two carrots you have put out this week led me to re-think that phrase of Whelan's that struck me as curious and ask the same question again....why would he have said something like that when the rest of the interview was friendly? My answer was and remains - nno need, therefor nit still seems curious.
It was directly related to J&J and Tylenol. Could one infer that to be so aggressive with such words may mean Whelan has had discussions with J&J already? Did he approach J&J? Did J&j approach him? Was Whelan rejected? Who said anything about "sharing"?. Seems to me the words came out of left field and had some kind of meaning?
Please tell me if you think I'm reaching or being picky, but it still seems to me that phrase is out of sync with the balance of the interview. I'm going to try to go back and listen to the interview again today, maybe it will become clearer.