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A King Sized welcome to our newest shareholder,$treet Trader, and his 3200 followers!!
The BIEL Train is leaving the station, get on board or get out of the way!
Simpsonly is more knowledgeable on the 510k process than I. The basic timeline calls for:
Day 7 - acknowledgement of receipt
Day 15 - accept submission or advise of deficiencies
Day 60 - substantive review
Day 90 - decision
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#timeline
The sad thing llh222 is that this is how the system works much of the time in the world of Big Pharma. Insys, who had revenue of $77 million in Q2 2015, gets fined $1.1 million and a slap on the wrist.
If you or I bribed a doctor to push drugs on their patients the DA would be pushing for hard time in prison.
If you are interested in seeing how deep the rabbit hole goes check out "The Black World Of Insys Therpeutics"
http://www.nasdaq.com/article/the-black-world-of-insys-therpeutics-cm496755
Says a lot about the detractors who are trying to destroy BIEL doesn't yankee. ActiPatch, a viable alternative to being hooked on opioid pain killers, helping thousands of people in the UK avoid or kick pain killer drug addiction. And exactly why would someone spends several hours each day on a message board trying to drive the maker of ActiPatch out of business??
The US "Drugs will solve all your problems" culture fostered by the AMA and FDA is being exposed as the evil profiteering by Big Pharma that it is. Thousands upon thousands of people who have lost family and friends to addiction and the side effects of drugs are as mad as hell and they are not going to take it any more.
It looks like AW opened his wallet for legal services on the 510k this time around. This should be a quality submittal with Goodwin Procter involved.
Goodwin Procter’s largest office is located in Boston at the heart of the city’s financial district. We are the second largest law firm in the city, with over 450 attorneys. Goodwin Procter is a leader in civic, community and philanthropic efforts. Our practice is evenly balanced between business law and litigation. With particular strength in corporate, litigation, real estate, private equity, technology companies, intellectual property, financial services and products liability/mass torts, our attorneys represent some of the nation’s leading companies in complex transactions and high-stakes litigation. These practices are well-supported by specialty teams in tax and ERISA, as well as trusts and estate planning, environment and energy. Our clients range from emerging enterprises to the largest national and international institutions.
With a full-service team of attorneys spread across offices in Boston, New York, San Francisco, Silicon Valley and Washington, D.C., our Technology & Life Sciences attorneys help clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle.
We work with more than 1,000 technology and life sciences companies, 200 venture capital and private equity firms, and many of the leading investment banks worldwide. We take pride in understanding our clients’ businesses, share their entrepreneurial spirit and drive, and provide counsel in connection with company formation, venture financings, intellectual property protection and transactions, IPOs, mergers and acquisitions and other corporate matters. Our industries of focus include software, hardware, online content and commerce, IT services, clean tech, biotech, pharma, diagnostics, medical devices and healthcare IT, among others.
Illustrating our attorneys’ dedication to clients in these sectors, Goodwin Procter’s Technology & Life Sciences Group is frequently ranked among the most active legal advisors in the industry. U.S. News-Best Lawyers recently recognized us as “Biotechnology Law Firm of the Year” for the third year in a row. Bloomberg, BioPharm Insight, CapitalIQ, Pitchbook, Private Equity Analyst and PrivCo each ranked us in the top five most active firms for technology and life sciences industry venture financings, technology licensing agreements, IPOs and M&A exits.
Thanks seven, I did not get a chance to listen yesterday. Major points for me:
1) 1.6 billion potential customers worldwide suffering from chronic pain 116 million in US.
2) Additional products in the pipeline to treat conditions beyond musculoskeletal pain.
3) Mechanism of Action = stimulation of efferent nerves which stimulates blood flow.
4) OTC 510k will be filed with the FDA today or tomorrow.
5) 5 ongoing clinical trials for new products.
7) 7 published clinical trials.
8) 80-85% of chronic pain is musculoskeletal related which the Actipatch has excellent results with, 57% reduction on average.
9) 25% of customers are using the ActiPatch daily, 75% using as needed.
10) ActiPatch is the 2nd largest selling product on the Boots Website.
100% correct Simpson. These are the closing lines in a 3/2015 FDA response that I received:
"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. Thanks for your continued patience."
Makes total sense TJ. I must hit delete 3 or 4 times every day regarding survey requests. Most people are too busy to fill out surveys. And those trials were not free. Customers paid 2.95 GBP or $4.58 USD for the 7 day trial version of the ActiPatch.
Good point ricci. Sorry dd, I don't want to take away your livelihood. I will offer the same deal to askj. The clock is ticking, offer expires in 10 hours.
If you are so sure of yourself dd, why didn't you take my little wager from 8/2?
"dd says Biel is headed down. I say it is headed up. How about a friendly wager. BIEL is currently at .0008 . If it closes below .0008 on Friday 8/7 I will not post on ihub for 1 week. If it closes above .0008 on Friday 8/7 dd will abstain from ihub posts for 1 week. If it closes at .0008 it considered a draw. What do you say dd?"
Seven, Up 3 points from the .00068 T-Trades that have been transacting for the last week. The end of the day saw the bid fall off to .0006 so our 14 mil @ .00071 is considered a Buy. Final score:
Buys - 39.138 mil
Sells - 19.908 mil
This strong buy volume and the total volume pop to 59 mil may have some new eyes looking our way.
One other thought on the Registry Study published today. The PR for the AW interview states "Topics will Include UK Progress and New Clinical Publications". Notice the word "Clinical", which the Study was not, and the use of the plural "Publications". I think AW is saving some bullets for the interview.
If our mtoronto source is accurate there is also a 510K surfacing soon.
100% correct Yankee. The majority of people who try the ActiPatch come back for more because it reduces or eliminates their pain.
I think that we will have a pretty good picture of Q2 sales after the AW interview Wednesday AM. He has to through out some numbers or percentage increase.
BioElectronics' Landmark 5,000+ Chronic Pain Patient Study Published in Pain Management Medical Journal
Tue, Aug 4, 2015, 8:39AM EDT -
BioElectronics' Landmark 5,000+ Chronic Pain Patient Study Published in Pain Management Medical Journal
PR Newswire BioElectronics Corporation
FREDERICK, Md., Aug. 4, 2015 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of drug-free over-the-counter ActiPatch® Musculoskeletal Pain Therapy medical devices, announced today that its registry study of 44,000 users of its ActiPatch 7-day trial device has been published in the prominent peer reviewed medical journal Pain Management http://www.futuremedicine.com/doi/full/10.2217/PMT.15.35. More than 5,000 chronic pain sufferers responded to the survey and submitted an assessment.
Chronic pain is a major unmet medical need that affects 20 to 40 % of the global population (more than diabetes, heart disease and cancer combined.) The majority of chronic pain causes, 80-85%, are musculoskeletal in nature. Despite using an average of 1.9 drugs for pain, 86% of the respondents reported that prior to using ActiPatch, they had pain levels of 8+ on a 11 point VAS scale- indicating severe unresolved pain. Pain was reduced an average of 57% for 65% of ActiPatch Therapy users who reported suffering from conditions such as osteoarthritis, rheumatoid arthritis, fibromyalgia, sports injuries, post-surgical pain, tendonitis, and neuropathy. There were no side effects reported.
A 3-month follow-up survey indicated 80% of ActiPatch users continued to purchase and use ActiPatch. The long-term effectiveness of ActiPatch therapy was confirmed by 93% of survey respondents reporting sustained pain relief, a distinct decrease in their medication use, and a significant improvement in their quality of life.
Dr. Deepak Kotak, Executive VP of BioElectronics, a Fellow of the Royal College of Anesthesiologists said, "Musculoskeletal pain is an increasing problem with few appropriate, safe, drug solutions. ActiPatch is a safe, affordable, self-treatment for chronic pain."
The details of previously completed and published clinical trials can be found at http://www.bielcorp.com/clinical-evidence/.
I think the fear is when investors view a stock as sub penny it is easier to be driven back to that level after a reverse split. But as you point out the split its self takes away no shareholder value it is a perception issue.
Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs
Posted on July 24, 2015 by FDA Voice
By: Ben Fisher, Ph.D.
At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., and patients in this country will have earlier access to innovation.
One way the FDA can reduce the time and cost of a clinical trial is to determine if publicly available clinical data for medical devices with which we have considerable experience can be leveraged to develop a less burdensome clinical trial design.
The FDA has established a strategic priority of strengthening the clinical trial enterprise. This includes finding ways to streamline clinical trials so that fewer resources are required to bring a new device to the market.
Through strengthening the clinical trial enterprise, we hope to encourage manufacturers to study new and important medical devices in the U.S., helping us fulfill our vision of providing patients with high-quality, safe and effective medical devices of public health importance first in the world.
http://blogs.fda.gov/fdavoice/index.php/2015/07/improving-access-to-medical-devices-fda-uses-existing-clinical-data-to-reduce-premarket-data-needs/
dd says Biel is headed down. I say it is headed up. How about a friendly wager. BIEL is currently at .0008 . If it closes below .0008 on Friday 8/7 I will not post on ihub for 1 week. If it closes above .0008 on Friday 8/7 dd will abstain from ihub posts for 1 week. If it closes at .0008 it considered a draw. What do you say dd?
You have my vote biglued. You have great timing as this coming week looks to be a barn burner with AW interview/company update and the following week we have record setting 2nd Quarter numbers being released.
Welcome to the BIEL Board biglued1. We let Asshat post here to keep him off of the streets. The world is a better place that way.
Exceptional acceptance ActiPatch Therapy is achieving in the UK
UpTick News Wire Radio Show Will Interview BioElectronics’ CEO Andrew Whelan
Topics will Include UK Progress and New Clinical Publications
FREDERICK, MD. August 3, 2015 — BioElectronics Corporation (OTC Pink: BIEL), maker of consumer medical electronics products for pain management announced that Andrew J. Whelan, President will be interviewed by Stu Taylor on his program “On Business“ at 9am EST on Wednesday, August 5th. To listen to the interview live, tune to:
http://tunein.com/radio/Money-Matters-Boston-1120-s27548/
Mr. Whelan is expected to report on the exceptional acceptance the company’s flagship product ActiPatch Therapy, is achieving in the UK. Other topics for discussion include upcoming clinical publications and the status of its US FDA market clearance progress.
http://www.bielcorp.com/uptick-newswire-radio-interview-bioelectronics-andrew-whelan/
Thanks seven. There are hundreds of testimonials like these from honest people who want others to know that the ActiPatch has changed their lives. I have said it before but it deserves repeating. It feels GREAT to own part of a company that is helping so many people reduce and eliminate their pain.
One poster on this board would have you believe that they are all paid off by AW. Give me a frigging break.
The BIEL train is leaving the station. Get on board or get out of the way.
Good old dd knows that there is a string of positive news in the pipeline. The next few days are his last hurrah before his status shifts to "Permanent Ignore".
Funny thing askj, I have been following BIEL for about 7 years and do not recall a stock split ever taking place. I did an OTC split search and got a "No Data Found" answer. BIEL has been around for about 11 years and never had a split and you are trying to sell a story that BIEL is a "wash, rinse, repeat" stock scam??? Good luck with that and Good For You (GFY).
http://www.otcmarkets.com/market-activity/splits?search=BIEL&searchType=symbol
Soooo Stock, do you really expect anyone to believe that a week before the company update and 2 weeks before the Q2 stats are released AW is going to through a wet blanket on everything by confiding in a shareholder that he is planing a RS???
BIEL should be partnered with "Fed Up". Look at Fed Up's Platform:
2015 Fed Up! Coalition Platform
We are in the midst of a severe epidemic of opioid
addiction and overdose deaths acknowledged by the federal government as the worst drug epidemic in U.S. history.
Overprescribing of opioids has harmed millions of pain patients and led to sharp increases in addiction, heroin use, injection
related diseases and infants born opioid-dependent.
The epidemic is having a catastrophic impact on families and communities and is placing a tremendous strain on our health care system, workforce, and legal system.
To date, the response from the federal government has been slow and tragically ineffective. Together, we must find new ways to
prevent opioid addiction, to ensure access to effective opioid addiction treatment and to reduce opioid overdose deaths.
http://feduprally.org/
The BIEL PR Dept should be all over this. An activist organization ready to hit the street and protest the prescription drug epidemic. Most of these people have family or friends that have died due to drug overdose. BIEL's non-drug, non-addictive pain relief products are a perfect fit to reduce drug use.
The coach on yahoo disputed the interview comment regarding a possible split.
coachpappy33 • 1 hour 52 minutes ago
Here's a novel idea for ihubbers.....
Instead of believing what someone said about a discussion with Andy about a reverse split, email Paul knopick and ask him. You will find there have been no discussions of a reverse split. Let the rhetoric continue or do some dd for yourselves.
The FDA has already approved BIEL's product for prescription use under the ActiBand name.
"This letter will allow you to begin marketing your device as described in your Section 5 10(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device to
proceed to the market"
http://google2.fda.gov/search?q=cache:0dCNdy3azQcJ:www.accessdata.fda.gov/cdrh_docs/pdf2/k022404.pdf+actiband&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&ie=UTF-8&access=p&oe=UTF-8
The FDA equivalent in dozens of other countries have approved BIEL's products for OTC sale.
I hear you Simpson and agree. If the FDA were a business they would be out of business because they don't meet their commitments.
I try and focus on Dr. Kotak's words when he said that BIEL will be successful with or without the FDA. I feel that Dr. Kotak is the force behind our success in the UK. AW needs to stay behind the curtain and let the good Doctor who is also a Lawyer become the public face of BIEL.
Unfortunately super it seems that the FDA is oblivious to pebbles.
The only things that can rattle their ivory tower are the President, Congressional Hearings, and public demonstrations.
After former FDA Chief Margaret Hamburg approved Zohydro, a strong new opioid drug, going against her advisory board, the "Fed Up" organization held protest marches. Hamburg resigned several months later.
http://abcnews.go.com/blogs/politics/2014/09/at-white-house-prescription-drug-protesters-call-for-new-fda-chief/
In this case it is more than an opinion Lizanne. A Jihad was declared many years ago over an employment dispute. Our Jihadist will fight on as long as there is breath in his body.
The comparison to Coronado is fine by me. It is one of the nicest communities in my area. Homes go for an average of 1.3 mil. The Hotel Del Coronado has been a top Southern California destination for 125 years. The Naval Air Station at Coronado is home to many of our nations best military men and women.
UK, this could all be just MMs balancing their accounts but the general rules of trading are as follows.
If the transaction occurs closer to the Ask price it is considered a Buy, closer to the Bid price it is considered a Sell. .00068 is 2 points away from the Ask, and 8 points away from the Bid therefor it is acknowledged that the buyer wanted the 9 million shares more than the seller wanted to sell them and the buyer capitulated and moved close enough to the Ask to trigger as deal.
We have no control over the FDA and their bureaucratic maze of a system for reclassification but we do know that in a little over two weeks Q2 data will be released. Q2 sales is the current object of my interests and why I have added 10% to my 8 digit position.
With the bid at .0006 and the ask at .0007 today's T-Trade of 9.389 million shares at the transaction price of .00068 was a Buy.
22 16:04:36 0.00068 9,389,417 form t nasd 0.0006 0.0007 9,389,417
BuyVol .................SellVol
14,622,917 ...........10,928,965
http://ih.advfn.com/stock-market/USOTC/bioelectronics-corp-pc-BIEL/trades?trade_set=recent
dd, I don't quite see your logic here. There were ZERO transactions at .0006 today. There was a 3 million share Form-T transaction reported after hours at a price of .00068 . If you say that you were rounding, why did you go down 8 points rather than up 2? Please explain your reasoning to the board.
22 16:06:54 0.00068 3,000,000 form t nasd 0.0006 0.0008 3,000,000
All great points seven. There is overwhelming evidence that BIEL is gaining momentum. To expand on just one of your points, the Boots relationship. Boots, now the Walgreen Boots Alliance, the first major retailer to stock ActiPatch on it's shelves. Boots rolled out the ActiPatch to 310 stores in 12/2013. After seeing the sales numbers Boots added an additional 275 stores to their ActiPatch program in 4/2015. 585 stores stocking the Actipatch may sound great, and it is. The even greater part is that Boots has a total of 2500 stores in the UK. There is much more growth to come in the UK market.
Boots is not just a UK business. Check out the total scope of their stores:
Number of retail stores by country*
United Kingdom 2,511
Mexico 1,021
Chile 447
Thailand 254
Norway 160
Republic of Ireland 80
The Netherlands 67
Lithuania 25
Total 4,565
The acquisition of Boots by Walgreens adds another 8000 stores to Walgreens Boots Alliance.
So dd, the hundreds of positive posts from ActiPatch users are all plants by the company and the handful of negative post are honest feedback? Is that your theory?
"You-can-see the manipulation in-the 1000share painted lifts"
What stock are you talking about??
Today's score for BIEL:
Buys = 3,994,552 all at.0008
Sells = 223,015 20k at .00071 , 203k at .0007
After close T-Trade Report = 1,553,700 at .00078 classified as a Buy
96% of the action today was BUYING!!
Wow!! 11am and already 10 posts in the bag. dd is in Blitzkrieg mode. Must be good news on the way.
Thanks for alerting the board to the mtoronto post yankee. mtoronto now has a follow up Yahoo post titled 510k:
"I have mentioned this before, a 510K can be submitted prior to the final order with special circumstances asking for OTC clearance. Coupled with the fact that a publication is due in the coming days, expect great news.
Trust this helps."
http://finance.yahoo.com/mb/BIEL/#mbt=510K&mbl=http%253A%2F%2Ffinance.yahoo.com%2Fmbview%2Fthreadview%2F%253B_ylt%253DAvXR8tpMy5gUMz992uXYgBHeAohG%253B_ylu%253DX3oDMTB2cGljN2lsBHBvcwMxNQRzZWMDTWVkaWFNc2dCb2FyZHNYSFJVbHQ-%253B_ylg%253DX3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-%253B_ylv%253D3%253F%2526bn%253Dd339e701-da16-34c3-9488-7eda96ab4804%2526tid%253D1437424600153-9aa7dc19-d258-4b11-ba28-6892418161de%2526tls%253Dla%25252Cd%25252C0%25252C3&mbtc=mb-tab-topic
If you are going to start trashing Chinese manufactured products you will have to first hand over your iPhone and any other Apple product you own, HP computer/printer, Samsung computer/printer/smart phone, Sony camera/laptop/camcorder. And thousands of other products from most of the world's major manufacturers. Welcome to the Global Economy.
https://www.facebook.com/lloydspharmacy/posts/10152588486382609
Sharon Dalrymple?LloydsPharmacy
July 14 at 11:24am ·
Please start stocking acti-patch I can't live without it as a Eds Ht patient and it would help if I could it locally, would make a huge difference, thank you
??
Like Comment Share
LloydsPharmacy Hi Sharon
I've asked our Buying Team about this and will let you know as soon as I've heard something.
Kind regards
Ian
Like · Reply · 1 · July 16 at 2:12am
https://www.facebook.com/lloydspharmacy/posts/10152590159022609
Susan Jackson?LloydsPharmacy
July 15 at 10:06am ·
Please lloyds can you stock actipatch
Like Comment Share
LloydsPharmacy Hi Susan
I've mentioned this to our Buying Team and will let you know as soon as I've heard anything.
Kind regards
Ian
Like · Reply · 1 · July 16 at 2:13am