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OK, I have to hear your logic on this one dd. Why would Europe's largest organization of health care professionals dealing with pain waste their time listening to not one, not two, but Three presentations on a "worthless device"?
These busy professional meet once a year for 4 days so does any rational person believe that they would squander their time and risk their reputation allowing 3 presentations on a "worthless device"?
Thanks uk . This is the the big annual event for European pain management with over 4000 attendees. Information from this meeting is monitored by all pain specialist across the world. 9/2-9/5 .
"The European Pain Federation EFIC® is a multidisciplinary professional organisation in the field of pain research and medicine, consisting of the 37 chapters of the International Association for the Study of Pain (IASP®), which are the IASP approved official National Pain Societies in each country. Established in 1993, EFIC’s constituent chapters represent Pain Societies from 37 European countries and close to 20,000 physicians, basic researchers, nurses, physiotherapists, psychologists and other healthcare professionals across Europe, who are involved in pain management and pain research."
"
Another low volume day @ 23 million shares. What I don't understand is how AW can dilute at 30 million shares per day when it has been over a week since we had a 30+ million share day. Please explain your "30 million share a day dilution theory" again for us dd.
Are you looking at the wrong stock again dd?
Buys = 15.4 million shares
Sells = 1.1 million shares
Only 200k shares have sold at .0006
I would be surprised if there is much volume at all in the sixes and the fours are only in your dreams. We are too close to the finish line. Reclass, over due and the final order can happen at any time. 501k, T minus 70 days and counting. Official PR on BIEL's three new products, Migraine, Incontinence, Diabetes, at any time.
Open your wallet and pay the current market price. Oops, too late, those Sevens are gone.
Jump on those Sevens before they are gone. Only 585k left!
I think we need some simpsonly analysis to correctly crack the BIEL code on this PR but here is my take.
1) ActiPatch US is going to Walgreens as they already have a successful relationship in the UK and over 8000 US stores.
2) BIEL is looking for a partner to market ActiPatch in Germany, France & Spain but will break up these territories individually if needed.
3) Conspicuous by its absence, Recoveryrx is already taken by B. Braun.
4} Our 3 new products are Wound Healing, Incontinence and Migraine Headaches. These are the ones that AW mentioned in his interview that have 5 Clinical Trials in process. BIEL does not have the resources to market these new products and needs a licensee.
The new products were the main reason for the PR IMO. Get some buzz going and generate interest in the pipeline. This is a big accomplishment for a small company like BIEL, 3 new products in clinical trials at the same time.
Interesting story about FDA & Flibanserin.
http://www.vox.com/2015/8/18/9173067/flibanserin-female-viagra-science
fuente, I have sifted through dozens of 2009 docs and have not found the FDA lawyers mentioned. Please advise who the "top flight law firm" was.
BIEL is not paying Goodwin Procter $800 per hour to fill out forms. They hired GP because their attorneys have been inside the FDA system. They know what a 510k needs to be successful. Batting averages are very important to these large competitive firms. They are not going to associate themselves with a marginal filing.
I don't believe that BIEL, or any other company, would make details of a 510k submittal public. I also believe that Goodwin Procter would not have advised BIEL to proceed with a 510k submittal unless they felt it had a very good chance of FDA approval.
Three of GP's FDA Division 4 lawyers have worked at the FDA. The fourth, Stephanie Philbin, helped Mark Heller and Kristin Davenport write an FDA document titled "FDA’s Preliminary Report and Recommendations for the 510(k)Program"
http://www.goodwinprocter.com/~/media/Files/Publications/Attorney%20Articles/2010/Heller_FDLI_10_10.pdf
Take a look at Vivian Pratt's work history and tell me if you think BIEL had world class advice in preparing and submitting their 510k.
Prior to joining Goodwin Procter, Ms. Pratt served as Vice President, General Counsel for Draeger Medical (a $2.7 billion per year company) U.S. legal entities, where she counseled clients regarding FDA laws and regulations, including strategies for 510(k) product clearance, 513(g) exemption status, responses to FDA inspections, review of advertising and promotion materials, investigational device exemption (IDE) requirements, QSR applicable to manufacturing and servicing of medical equipment. She also reviewed contracts for regulatory compliance and provided extensive training on FDA and anti-kickback healthcare laws. Before that, she was an attorney in the FDA Practice Group at the Washington, D.C. office of WilmerHale.
From 1999 to 2003, Ms. Pratt served as Vice President of aaiPharma, where she implemented business and regulatory strategies to improve commercialization of products and supervised FDA regulatory consulting pertaining to drugs and devices, including compliance issues, product development and approval, advertising and promotion, validation services and Good Manufacturing Practices (GMP).
Ms. Pratt held the position of Regulatory Counsel and was then promoted to Associate General Counsel/Corporate Secretary at Siemens Corporation from 1995 to 1999. As Regulatory Counsel, she assured compliance with the Consent Decree of Permanent Injunction in United States v. Siemens Medical Systems, Inc., et al. and successfully implemented a comprehensive GMP compliance strategy that resulted in FDA’s agreement to lift an Import Detention on products manufactured in Europe and Scandinavia (1995) and an Order of Dissolution of the Consent Decree of Permanent Injunction (1998) by the U.S. District Court of New Jersey. She counseled Siemens Medical Systems (U.S.) and Siemens AG on how to comply with FDA and other healthcare laws while advancing business objectives. In addition to manufacturing compliance issues, Ms. Pratt was responsible for legal oversight of other FDA regulated activities including device approval and promotion, product importation and clinical trials, as well as providing extensive training on these topics.
From 1992 to 1995, Ms. Pratt served as Associate Chief Counsel for Enforcement and then Associate Chief Counsel for Devices at FDA. As a member of the Office of Chief Counsel, she provided legal advice on agency policies and actions to Office of the Commissioner and other decision makers at FDA headquarters and district offices, including the Center for Devices and Radiological Health (CDRH). Representative issues include enforcement matters such as FDA inspections, product seizures and injunctions, GMP compliance, civil money penalties, 510(k), IDE and PMA submission requirements, labeling and advertising review and import/export advice. Ms. Pratt also worked with the Department of Justice on civil and criminal matters.
Ms. Pratt is a member of the FDA Alumni Association. She is a member of the D.C. Bar Association and the Louisiana Bar Association.
The ActiPatch 510k filing was an FDA suggested course of action due to the delay in completing the SWD Reclassification.
Thanks Yankee. The FDA is reviewing the ActiPatch 510k while the White House needs non drug solutions to pain killer addiction. Talk about good timing!
It was a 2.5 million share Buy at .00069 .
http://ih.advfn.com/stock-market/USOTC/bioelectronics-corp-pc-BIEL/trades
Excellent points Simpsonly. BIEL has definitely upped its game with the addition of Dr. Kotak and legal representation from Goodwin Procter. The FDA, realizing that it did not have the staff to properly evaluate bio-electronic devices, brought the talent on board to properly evaluate this growing field in the medical industry.
Neuromodulation is going to be a big part of BIEL's future.
"Wherever there is a nerve that is accessible to our technology we can stimulate it. And that gives us access to some very large markets where there are unmet medical needs.So I think that over the next 1-2 years we will have more exciting news as we enter this area and generate what we think will be ground breaking data. Because what we can do the other technologies can not, because we are non-invasive and we are cheap, and ease of use is very important, so we believe we can look at some of the hospital indications and bring them to the OTC market where it will give access to the many and not the few."
An opinion is what you have when you don't have any facts. When you have the facts, you don't need an opinion.
Facts - The final order for Reclassification and Renaming of Shortwave Diathermy for All Other Uses is over due and could be published at any time.
- A new 510k was filed for the ActiPatch on 8/6. The FDA suggested this course of action while waiting on the final order. BIEL was advised on this filing by the law firm of Goodwin Procter, whose lead FDA attorney Mark Heller has 10 years experience working with the FDA's Device Division. The FDA has a commitment to process 510ks within a 90 day period.
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142209.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf13/K132194.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141286.pdf
- As of 6/30/2015 BIEL had sales of $1,178,796 for fiscal 2015. This is a $732,516 increase over the same period in 2014.
- There are 585 Boots Pharmacy Stores selling BIEL products in the UK.
- B. Braun, a 175 year old company that sells $6 billion a year in medical products, signed on as the exclusive UK distributor for Recoveryrx after clinical evaluation.
- In his 8/2014 interview BIEL EVP Dr. Kotak said " I joined Bioelectroincs in March (2014) with a roll to drive the European and Rest of World roll out of the current product line as well as bring on the development of the deep and diverse pipeline that Bioelectronics has." " We are the leaders in non invasive electrocuticals and we have new devices for chronic pain that are more powerful and we are going to be entering the field of Neuromodulation. Wherever there is nerve that is accessible to our technology we can stimulate it, and that gives us access to some very large markets."
- Neuromodulation is technology that acts directly upon nerves. It is the alteration—or modulation—of nerve activity by delivering electrical or pharmaceutical agents directly to a target area.Neuromodulation devices and treatments are life changing. They affect every area of the body and treat nearly every disease or symptom from headaches to tremors to spinal cord damage to urinary incontinence. With such a broad therapeutic scope, and significant ongoing improvements in biotechnology, it is not surprising that neuromodulation is poised as a major growth industry for the next decade.
- In his 8/2015 interview AW said " We have 5 on going clinical trials that we are doing for new products. We clearly see that we can solve and use the product for things like Migraine Headaches, Diabetic Neuropathy, and Post Operative Chronic Wounds."
- Hundreds of testimonials are available on the WWW with real people telling their story of how the ActiPatch has changed their life by eliminating or reducing their chronic pain.
Looks like somebody liked the Q2 report. Over 8 million in BUYS at .0008 and Zero SELLS so far today.
Great sales numbers indeed yankee! Sales more than doubling over 2014. Reducing cost of production by 19%!! And the Big One, Gross Profit up over 4x !!!
Some will complain about the costs but look at everything AW is doing:
1) Filing the 510k- Several thousand dollars for the FDA submittal fee, world class law firm to give BIEL the best chance of success, clinical trials to document the ActiPatch reducing pain and decreasing healing time.
2) 5,000 Chronic Pain Patient Study- Gathering information from 5000 customers, Dr. Rawe & Dr. Kotak's efforts to analyze all of that data and produce a document suitable for publication in a major medical journal.
3) New products in the pipeline- In the AW interview he stated that BIEL currently had 5 clinical trials in process to support new products that are in development. He was not specific but mentioned the areas of Migraine Headaches and Diabetes. R&D for new products is expensive but it is what drives company growth. Clinical trials are expensive but we need them to get the products into the market place.
I know there many other necessary expenses in operating the company but these are the ones that come to mind as they are in the headlines. And those headlines are not without cost. PR Newswire charges a fee to get the word out about BIEL's successes.
As much as everyone, except dd, would have liked us to have US OTC years ago I feel having the UK as a trial market will work to BIEL's advantage. Find out what works & what doesn't in a smaller market and transfer that knowledge to the US.
Time for a new calculator dd.
Cost of Goods are down not up.
2015....... 383k (cost/goods) is 56.7% of 675k (sales)
2014....... 208k (cost/goods) is 75.3% of 276k (sales)
Sales more than Double. Gross Profit more than Quadruples. Cost of Goods reduced by 19%.
.............. June 30, 2015 ..........June 30, 2014
Sales ............ 675,348 ................276,696
Cost/Goods .....383,894 ............... 208,195
Gross Prof. ......291,454 ................ 68,501
45 days would be 8/14 .
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Ivivi doesn't seem to have done much with the Sofpulse. If you look at their website the News/Media sections most recent article is from 2011.
http://www.ivivihealthsciences.com/patients-news.htm
Are you looking at the correct stock dd? Less than 2 mil in BIEL transactions in the first 1 hour and 15 minutes. 1.7 mil of that volume were BUYS at the .0008 Ask. 150k in SELLS at the .0007 Bid.
Thanks yankee, 4 products in the top 10!! Canada is cooking!!
Don't loose any sleep over the assembly facility in China dd. I am sure that AW got several bids when he went shopping for an assembler. China is the world's second largest economy they are not going the way of Greece.
redzone was propagating a factually incorrect assertion that the CDRH would not review a 510k until the reclassification of SWD devices was finalized. This is totally incorrect. Several long time board members have written correspondence from the FDA saying, sorry this taking so long but the 510k is still available for approving devices. This is why AW, guided by Goodwin Procter, prepared and submitted the 510k.
So yes, the difference between not processing a 510k until the final ruling is published and processing a 510k while we wait on the ruling is an important issue.
What part of the following statement from the FDA do you not comprehend?
"I assure you that FDA remains committed to finalizing this reclassification in the near future, but unfortunately, this process takes time. In the meantime, these devices can still be cleared for marketing through our 510(k) process."
Original Synopsis
Jul 23, 2015
Portable battery-powered pulsed Electromagnetic field (PEMF) devices
Solicitation Number IHS126638
Agency: Department of Health and Human Services
PURPOSE OF THE CONTRACT: Procure portable battery-powered pulsed electromagnetic field devices as part of providing wound care services to IHS beneficiaries.
We need HHS to send a memo over to CDRH at the FDA telling them they need the ActiPatch.
https://www.fbo.gov/index?s=opportunity&mode=form&id=9ef91f9cd2720314ed8a9e97708023bc&tab=core&_cview=0
Interesting that you would depict a BUY above the closing price and above the closing Ask price as a "dump".
http://ih.advfn.com/stock-market/USOTC/bioelectronics-corp-pc-BIEL/trades?trade_set=recent
The FDA should have been close to the final order a year ago. Remember, this was a six month process initiated by the FDA in 2/2014.
I can only speculate as to why BIEL chose to proceed with the 510k. However I am sure that they consulted with their legal counsel. Read the bio on Mark Heller and let me know what you think.
http://www.goodwinprocter.com/People/H/Heller-Mark.aspx
Prior to joining Goodwin Procter in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources.
Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC.
That is odd redzone. In March I received a response from the FDA to my inquiry on the reclassification status that stated otherwise.
"I assure you that FDA remains committed to finalizing this reclassification in the near future, but unfortunately, this process takes time. In the meantime, these devices can still be cleared for marketing through our 510(k) process."
Does anyone really think that BioElectronics, under the legal advise of Goodwin Procter's Mark Heller, a former FDA Associate Chief Counsel for Medical Devices, a 510k would be submitted that could not be considered?
Based on the facts I would disagree with you dd.
Fact #1) First Quarter 2015 sales were $503k a 297% increase over Q1 2014.
Fact #2) In April of 2015 Boots Pharmacy, the largest pharmacy chain in the UK, increased the number of it's stores carrying the ActiPatch by 275, bringing the total stores to 585.
Fact #3) ActiPatch is consistently on the top sellers list in its category for Amazon Canada, Amazon UK and Boots.com .
The Q2 2015 sales numbers are coming out at the end of the week and will add another fact to confirm the rapid growth of Bioelectronics.
Arizzle, I am going by ihub's Trade report.
BUYS = 82.881 million shares
SELLS = 41.181 million shares
http://ih.advfn.com/stock-market/USOTC/bioelectronics-corp-pc-BIEL/trades?trade_set=recent
If you want to travel down the "How do you know" road I will follow you. There were 56.6 million shares reported shorted today by the market makers. How do we know that half of today's volume was not MMs selling shares that they don't own?
20150810|BIEL|56692742|0|105593849|O
http://regsho.finra.org/FORFshvol20150810.txt
Its right here on ihub yankee. Go to the DATA tab, drop down will have a DATA TOOLS option, select TRADES off of the DATA TOOLS sub menu.
http://ih.advfn.com/stock-market/USOTC/bioelectronics-corp-pc-BIEL/trades?trade_set=recent
Nice run, 12 mil in Buys @ .0011 in 50 minutes! Returning strong after the day traders have bailed.
dd wrote "So and thus, we have seen that BioElectronics hiring a lawyer to help in the FDA smittal might seem a good thing but, it is IMO just the opposite. A BIEL history lesson should have taught them that you can't intimidate the FDA, even with a lawyer. They have better lawyers."
Most companies that are submitting a 510k seek legal advice. It is a complex process and few companies, especially in the development stage, have the in house expertise to know the legal details of a 510k filing.
Bioelectronics is not trying to "intimidate" the FDA. They wanted a professional filing that had the best chance of approval so AW hired one of the best firms in Boston, Goodwin Procter. Goodwin Procter's Director of their FDA Division is Mark Heller. Mr. Heller spent over 10 years working for the FDA. He knows the FDA system very well, what works and what doesn't.
Mark Heller's Professional Experience:
Prior to joining Goodwin Procter in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources.
Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC.
JustGo, Don't forget the economies of scale cost savings waiting for BIEL as we grow. If each unit is running $5-6 for our current orders of say 5,000-20,000 units, our costs could easily be cut in half as demand doubles and triples. Another $2-3 in profit per unit by simply selling more of the same.
Learning by doing: There is growing evidence that industries learn-by-doing! The average costs of production decline in real terms as a result of production experience as businesses cut waste and find the most productive means of producing output on a bigger scale. Evidence across a wide range of industries into so-called “progress ratios”, or “experience curves” or “learning curve effects”, indicate that unit manufacturing costs typically fall by between 70% and 90% with each doubling of cumulative output. Businesses that expand their scale can achieve significant learning economies of scale.
http://fhseconomics.weebly.com/uploads/9/0/6/8/9068926/economies_scale_internal_external.pdf
World Class back up Lizanne! Check out the work history on the head of Goodwin Procter's FDA Division, Mark Heller.
Prior to joining Goodwin Procter in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources.
Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC.
The CEO of Steris, a little $1.85 Billion health care sector company, disagrees with your opinion of Goodwin Procter.
Biotechnology Law
"Mr. Heller's FDA practice at Goodwin Proctor is world class."
Walter Rosebrough STERIS Corporation
http://bestlawfirms.usnews.com/profile/goodwin-procter-llp/client-comments/16996
Goodwin Procter LLP is a leading Am Law 50 and Global 50 law firm, with offices in Boston, Hong Kong, London, Los Angeles, New York, San Francisco, Silicon Valley and Washington, DC. Excelling at complex transactional work and high-stakes litigation, the firm combines in-depth legal knowledge with practical business experience to help clients maximize opportunities and manage risk. With more than 850 lawyers, Goodwin offers innovative counsel and delivers results through a client-centric and collaborative approach. The firm focuses on matters involving financial institutions, intellectual property, private equity, real estate capital markets, securities litigation/white collar defense, and technology/life sciences.
Thanks for the PM Lizanne. Things are lining up in a big way for BIEL this year. Exciting times!!