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Adding one of the Worlds Largest Retailers to your growing list of stocking stores is NOT a "fluff PR"!!! They will not only be stocking ActiPatch but promoting the 7 Day Trial ActiPatch which is bring in so many repeat customers.
Everybody wants in on the ActiPatch Action!!! The BIEL MOJO is back!!! Yeah Baby!!!
BIEL does not have the resources to penetrate the hospital/doctor prescription market. Braun has good world wide coverage with a presence in 50 countries and name recognition that provides institutional confidence . If they want to run with RecoveryRx world wide let them, as long BIEL is properly compensated.
At this stage of the game, given BIEL's restricted research budget, I would say collaboration with Braun's R&D and Braun paying for clinical trials is a good deal for BIEL. Biel can apply the research findings to its own future products, Extra Strength ActiPatch, Migraine ActiPatch, ???? ActiPatch.
I am with you 100% regarding the US Prescription Drug Epidemic. It is criminal that PEMF and other non-drug therapies have been withheld from the American people by the US medical establishment and the FDA. Fortunately for PEMF that is starting to change.
Why don't you do a survey. Contact 5 or 10 companies that have 510k applications in review with the FDA and see how many "k numbers" that you receive. Then we will know if BIEL is over protective or this is normal corporate behavior.
I found AW's comment regarding the RecoveryRx testing for Braun interesting. He said "testing at power levels" to get the prescription device. It looks like Braun is working with BIEL to boost the output on the prescription RecoveryRx that they include in their Post-Op Recovery Kit. It makes sense to differentiate the hospital device from the OTC unit as it will probably sell for 3x the OTC. Also means 3x the profit for BIEL on these prescribed units.
It is taking longer than most wanted but it sounds like Braun is getting it right. You don't stay in business for 175 years by doing things half baked.
What purpose would having the number serve? The FDA makes no information about a 510k application available to the public until they have a final decision. The FDA updates their data base weekly for final decisions. You can type a non-finalized "k number" into a FDA data base all day long and receive "no results" each time.
BIEL does more than a Billion shares of volume on big news days, It will move up. I would wager that many of those shares on the .0011 Ask are the MMs offering shares that they don't own.
I was hoping for an example or two so we could see what they made public, oh well.
Thanks Truth, Makes perfect sense.
fuente, you seem to have a decent grasp on the world of the FDA. Are there examples of device companies with 510k applications in process at the FDA advising their shareholders on every communication from the FDA before a final decision is reached?
Gotta Love the US Drug Culture
Our opioid pain drug will make you feel better, but it may have side effects, but we have a drug to take care of the side effects, but it does have some side effects also.
How about drug free, side effect free pain relief with ActiPatch.
FDA Approves Movantik for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.
Common Movantik side effects include abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache.
Please advise the board what SWT devices in the new Class 2 designation, initiated on 10/13, have been approved.
"The category has had approvals in the last month since the new category, in this new category."
100% Incorrect. AI is ADDITIONAL INFORMATION
C. Request Additional Information (AI)
FDA requests AI when the 510(k) submission lacks information necessary for the agency to continue or complete the review and to determine whether the device is SE or NSE (21 CFR 807.87). AI requests may be issued by letter, or may be issued by telephone, fax, or e-mail, with a follow-up letter informing the submitter that the 510(k) is being placed on hold pending receipt of a response to all of the identified deficiencies. The hold starts on the issue date of the detailed AI letter or the letter confirming the hold relating to AI issues that were conveyed by telephone, fax or email.
FDA generally issues an AI request when FDA believes the additional information needed from the submitter is not suitable for interactive review and/or cannot be provided within a reasonable period of time (i.e., such that the review would be unduly delayed if the submission were not placed on hold).
An AI request is an interim action that stops the review clock and marks the end of an FDA review cycle. The review clock will resume upon the receipt of a complete response to the AI request in the appropriate Document Control Center.
Obviously you did not read your own link.
"The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request.
Additional Information Request stops the FDA clock. Is that really difficult to understand or just inconvenient.
The 90 day goal and 100 day MDUFA are all FDA working days. If the FDA has a question or requests further info the FDA clock stops until the issue is satisfied.
Being that this is probably the first 510k that the FDA is processing under the new Class 2 designation for SWT there is undoubtedly going to be some issues to clarify/resolve.
K022404 , under Actiband name.
The answer is in the name of the website. There is only public info on 510k submissions after there is a decision. Look at the 510ks on this site all have decisions.
Interview - 2400 stores in UK by 1/2016
The FDA clearance opens up US OTC markets. The rumored licensing deal is with a big pharma player for US rights with 50 mil upfront and royalties.
The FDA clearance triggers the licensing deal. BIEL is GOLD upon FDA clearance. BIEL is profitable in 2016 on European and Canadian sales alone.
Three subjects specified in the PR, FDA status, UK sales, and Canadian distributors.
Get some sleep boys and girls for tomorrow will be an exciting day!
BIEL just signed up 1137 new Lloyds Pharmacy and Gordons Chemist stores to carry the ActiPatch products and they are going to celebrate with a reverse split and BK. If this sounds logical to anyone please sell any stock you have in the company immediately.
BIEL.... FDA NEWS from CEO Thursday 11/5 9 am
FDA News
UK Sales News
Canadian Distribution News
http://tunein.com/radio/Money-Matters-Boston-1120-s27548/
BIEL is ready to make a big move. They signed a thousand store UK distribution deal with Lloyds Pharmacy two weeks ago. This is in addition to 585 existing Boots/Walgreens UK stores carrying the ActiPatch pain relief products. Year over year Sales more than doubled the last two quarters.
The big play is US FDA OTC Clearance. Three weeks ago the FDA reclassified BIEL's products from Class 3 to a Class 2, simplifying the clearance process. A 510k Premarket Application is currently in review by the FDA.
BIEL.... FDA NEWS from CEO Thursday 11/5 9 am
FDA News
UK Sales News
Canadian Distribution News
http://tunein.com/radio/Money-Matters-Boston-1120-s27548/
BIEL is ready to make a big move. They signed a thousand store UK distribution deal with Lloyds Pharmacy two weeks ago. This is in addition to 585 existing Boots/Walgreens UK stores carrying the ActiPatch pain relief products. Year over year Sales more than doubled the last two quarters.
The big play is US FDA OTC Clearance. Three weeks ago the FDA reclassified BIEL's products from Class 3 to a Class 2, simplifying the clearance process. A 510k Premarket Application is currently in review by the FDA.
BIEL.... FDA NEWS from CEO Thursday 11/5 9 am
FDA News
UK Sales News
Canadian Distribution News
http://tunein.com/radio/Money-Matters-Boston-1120-s27548/
BIEL is ready to make a big move. They signed a thousand store UK distribution deal with Lloyds Pharmacy two weeks ago. This is in addition to 585 existing Boots/Walgreens UK stores carrying the ActiPatch pain relief products. Year over year Sales more than doubled the last two quarters.
The big play is US FDA OTC Clearance. Three weeks ago the FDA reclassified BIEL's products from Class 3 to a Class 2, simplifying the clearance process. A 510k Premarket Application is currently in review by the FDA.
<<<BIEL>>> FDA NEWS from CEO Thursday 11/5 9 am
FDA News
UK Sales News
Canadian Distribution News
http://tunein.com/radio/Money-Matters-Boston-1120-s27548/
Today's large block trade of 19 million went for .000995 so I think your 8 and 9 wishes will go unfulfilled unless there is a major shift in sentiment.
Why not average in. Get some at .001 so that you are in the game and see how things look tomorrow.
Well I guess you can't blame a guy for trying. It is a pretty long shot as only 20k have gone in the 9s today, they were at .00095, and there are over 40 million customers to serve before you get to the head of the line.
I hope that you are wearing a neck brace Red. The rapid rate at which you are changing direction is sure to give you whiplash.
The firm representing BIEL is Goodwin Procter.
http://www.goodwinprocter.com/Practices/Specialty-Practices/FDA-Group.aspx
Mark Heller is the head of their FDA group.
Mr. Heller has been listed in Chambers USA: America’s Leading Lawyers for Business (Band 1) from 2007 to 2014, U.S. News–Best Lawyers from 2012 to 2015 and The Legal 500 U.S (2014). He has been prominently featured as one of three “leading” lawyers in the 2006/2007 and 2008/2009 editions of PLC Cross-border Life Sciences Handbook in the USA Regulatory [Medical Devices] category, and again recognized by PLC in the 2010/2011 Cross-border Life Sciences Handbook in the USA Regulatory [Medical Devices] category. Mr. Heller was also named a “Leading FDA Lawyer” in 2005 by the Legal Times, which recognized him as an “intellectual powerhouse” and praised his significant knowledge of the law on medical devices and his specialty – “getting the green light from the FDA.” He was recognized by Washingtonian magazine in 2004, 2007, 2009, 2011 and 2013 as one of the top lawyers in Washington, D.C. in the area of food and drugs, selected as a “D.C. Super Lawyer” in 2007, 2008, 2009, 2010, 2011, 2012, 2013 and 2014, listed in The International Who’s Who Legal of Life Sciences Lawyers, and was also named a “Best Lawyer” in the Corporate Counsel Annual Guide to FDA LAW for 2010.
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.
No FDA Regulations are being changed or added. This is an FDA Proposed Guidance Document explaining how Premarket submittals should prove their electrical safety. If you would read the proposal it is very clear.
This is a proposed GUIDANCE for Electromagnetic Safety in Medical Devices. NO FDA STATUTES or REGULATIONS are changing. The FDA is saying this is what we will look for in premarket submissions to confirm electrical safety.
Quote: "This draft guidance, when finalized, will represent the
current thinking of the Food and Drug Administration(FDA or Agency)on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative
approach, contact the FDA staff responsible for this guidance
as listed on the title page."
This sounds like most of the negative posts on the board, a lot of accusations with very little factual evidence to support it. All this "I just received an e-mail" baloney is a feeble attempt to create legitimacy where there is none.
The Actiband successfully used the MRT Sofpulse as the Predicate Device to get FDA clearance in 2002 as did several other PEMF devices. Regenesis, ProMedTek, Ivivi, and OrthoCor all used the MRT Sofpulse as a Predicate.
The MRT Sofpulse was cleared for, adjunctive therapy for the mitigation of pain and edema in superficial soft tissue. Why would the Actiband, with its clearance for only Blepharoplasty edema, be used on the 8/2015 510k when the Sofpulse has such a broad clearance and has passed FDA Predicate use many times? Does anyone other than those that seek to destroy BIEL believe that the former FDA attorneys at GP would advise BIEL to do this?
The move to a Class 2 Device is a major change in the way the ActiPatch is reviewed. Below are excerpts from the FDA "Overview of Medical Devices and Their Regulatory Pathways":
Class I devices present a low risk of harm to the user and are subject to general controls that are sufficient to protect the user. Most are exempt from the regulatory process.
****************************************************************
Class II devices are more complicated and require special controls for labeling, guidance, tracking, design, performance standards, and postmarket monitoring. Most require Premarket Notification 510(k).
Premarket Notification (510(k))
510(k) is required when demonstrating substantial equivalence to a legally marketed device, when making significant modifications to a marketed device, and when a person required to register with FDA introduces a device for the first time. If a device requires the submission of a 510(k), it cannot be commercially distributed until the FDA authorizes it.
Substantial Equivalence
A device is substantially equivalent (SE) if it has the same intended use and same technological characteristics as a legally marketed device, known as the predicate. A legally marketed device:
was legally marketed prior to May 28, 1976 ("preamendments device"), for which a PMA is not required, or
was reclassified from Class III to Class II or Class I, or
was found SE through the 510(k) process.
Applicants must compare their device to one or more similar legally marketed devices and make and support their SE claims. If the device is SE to a predicate, it is placed in the same class. If it is not SE, it becomes non-SE and is placed into Class III.
****************************************************************
Class III devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They have the toughest regulatory controls. Most of these devices require Premarket Approval because general and special controls alone cannot reasonably assure their safety and effectiveness.
Premarket Approval (PMA)
PMA refers to the scientific and regulatory review necessary to evaluate the safety and effectiveness of Class III devices or devices that were found not substantially equivalent to a Class I or II predicate through the 510(k) process.
PMA is the most involved process. To reasonably assure that a device is safe and effective, PMA requires valid scientific evidence that the probable benefits to health from the intended use of a device outweigh the probable risks, and that the device will significantly help a large portion of the target population. Sources of valid scientific evidence may include well controlled investigations, partially controlled studies, historical controls, well documented case histories by qualified experts, and robust human experience.
Independence is an important concept for PMAs, meaning that each PMA should establish the safety and effectiveness of the device under review, and that data about one device cannot be used to support another.
****************************************************************
To state the change from Class 3 to Class 2 in simple terms the ActiPatch has gone from getting the scrutiny that a Pacemaker would receive for FDA clearance to now getting the scrutiny of a Powered Wheelchair.
Yeah right, BIEL is currently doing business with three Billion Dollar Companies, B. Braun, Boots/Walgreens, and Lloyds Pharmacy.
The list will be getting longer in the weeks to come.
IMO J&J is the leading suspect in the licensing deal with the $50 mil up front payment triggered by FDA US OTC that has been floating for the last year.
The ActiPatch accelerates the body's ability to heal its self at the cellular level. Shorter hospital stays, less time off work, drug free pain relief, Transformative.
"J&J wants to be the partner of choice for companies big and small that are interested in bringing excellent solutions to patients and to healthcare systems around the world." Rosengard said.
"FMD: On what basis do you evaluate a company for potential M&A deals or partnerships?
BR: First and foremost is this going to change patient outcome, which although infrequent in the device world, when it happens is transformative. So we are always looking for those opportunities."
J&J Device Heads Say More External Partnerships
"Johnson & Johnson ($JNJ) is shaking up its med tech innovation model. Its sprawling medical device unit had a quarterly operational sales increase of just 1.3% to $6.1 billion when adjusting for divestitures and foreign currency fluctuations. Add a negative currency impact to the equation, and the growth rate was -7.3%.
The company is applying its successful, outward-looking pharmaceuticals innovation model to med tech in the hopes of emulating that faster-growing unit's success. The global innovation centers designed to foster collaboration and innovation with startups and academics are increasingly being used to enhance J&J's device (rather than drug) ambitions."
http://www.fiercemedicaldevices.com/story/jj-device-heads-say-new-med-tech-innovation-model-calls-more-external-partn/2015-10-26
720 hours of therapy at $31 = 4.3 cents an hour. The best buy in drug free pain therapy there is! As a bonus you will also get a thank you card from your Kidneys and Liver.
Gordons Chemist has the ActiPatch Back and Knee products in their online store, Gordons Direct, two days ahead of schedule.
http://www.gordonsdirect.com/actipatch-720-hour-knee-pain-relief.html?___SID=U
I think that is the key at this stage of the game llh, play with a few shares but hold your core position. There are too many positive events in the BIEL Pipeline that could pop up at any time.
FDA 510k Decision
Canadian Costco/Walmart
German Retail
News on the Three New ActiPatch Products
Licensees/Partners
Deals from the Medica Trade Show 11/16
With 48 mil on the Bid at .0009 I would say your odds are slim to none. Nothing at all has gone at .0009 today. There have been five .00095 - .00099 trades all for 10,000 shares each, most likely MM bait.