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Investors may have a few days or maybe even a few weeks to get in. After that, it’s too late!
Hi Gramps, sorry to hear that. My belated condolences to you.
Riccikeeper
Yes, I will but only after we hear the huge news in the coming weeks. You haven't seen anything yet. This only the tip of the iceberg.
BTW- Did you hear about the guy that couldn't wait for success and went on without it? lol
Trust this helps.
I forgot to mention that there is also the avenue for accelerated approval, we don’t know for sure if they get it for the 510k but who’s to say that we don’t. LOL
Congrats to all. In a few weeks the 510k will be submitted for Musculoskeletal and hopefully the huge partner on the sidelines will step in.
This is only the beginning!
Yes, with certainty and without any doubt, I am defending Andy.
Did you know that CVS uses a Beacon to keep track of sales on new products, makes me wonder if the products made top 3 in sales? It seems that maybe another retail chain must have obtained the same info. LOL
CVS is alive and well!
BTW, did you also know that there is a distributor that supplies over 60,000 OTC outlets? It’s news to me if there is. LOL
Well, we are coming to a closure with the FDA and CVS. (Yes, CVS!) I don’t believe the wait is going to be too much longer. Do we get CVS as well as FDA clearance? Hopefully we get both! In a short time, it will all be determined.
May all the Posters on the board be blessed with great news!
Happy Easter
We are approaching the 60 day mark on the FDA timeline which will be on or before the end of April. The clock starts after the administrative review and on to substantive review. Will the clock stop for either or both submissions? nobody knows! FDA response at best without the clock stopping will be at the end of May, if stopped we are looking for June responses.
Have a nice day.
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM283707.pdf
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - U S Food and Drug Administration Home Page
Trust this helps.
“You reap what you sow” holds true both positively and negatively
The next BIEL announcement will settle many debates on this board.
Don't ask when! You will know when you see it.
Trust this helps.
Happy Weekend Everybody
Just so we have an understanding, BIEL received a CRL in November from the FDA. BIEL is now responding to the CRL. In respect to actions in the response, this response goes through a completely different FDA department. Actually in most cases it does. Trusting that the FDA accepts the response from BIEL, clearance may happen sooner then most think.
Government shut down over, two 510K's going in.
Trust this helps.
White_Knight
Trust you are well.
Andy’s press release last week did not go over very well with a lot of investors. How many of Andy’s letters, updates and press releases did not go well over the years?
Some of Andy’s statements or comments in recent years were about FDA-Petition reclassification, OTC, NHS, retail chains, and distributors. Well, did these actions take place? Has there been progress going forward?
Keith? Erin?
There may be investors that say that the accomplishments have taken too long but I do believe that the new investors that got on board in the past few weeks look at the future of the company not the past.
NB………………Most if not all actions stated in Andy’s press release will happen! Investors can read what Andy is saying but can they read what Andy is doing? Know the two and know the difference.
Upon final stats being completed and reviewed by a few PHD’S or should I say Statisticians and Mathematicians, there are 3 different manners in which the ActiPatch may be cleared.
1) 510K resubmission
2) Meeting with the FDA
3) Last but not least, communications through e-mails and telephone conversations may also clear the product.
The NSE was based on the evidence that was submitted in the 510K. The FDA panel is made up of bright intelligent people. There is no blame here, the FDA wants evidence to support the 510k and they will receive it and review it soon enough.
NBB………#1 will come out on a press release, #2,and #3 may be an FDA response to the Company!
Posters may be wondering why the stock price is not .04 cents with all that’s going on with the company. I can tell you with certainty and without doubt that upon a press release coming out stating OTC clearance of ActiPatch, 510K in FDA possession for postoperative pain, mentioning a partner and or the buyer of certain orders. I believe that the stock price will be higher than stated above.
Ubquubqu
This is a given!
Think outside the box and focus on a certain HealthCare Executive.
What name comes to mind? Who is hands on at the moment?
Tropical Stocks
This is where we are headed. I am using cautious words in my post and only my thoughts.
There will be an announcement from the company once confirmation is made for the FDA meeting in 2019. The company may or may not address the NSE with their new stats for women. The FDA may or may not clear the product at that time. The FDA may send out a letter following the meeting that the product may or may not be cleared.
Looking back at the winter of 2016, the FDA denied clearance of the Acti Patch. January 2017 meeting with the company and the FDA, a few weeks later clearance was issued for Foot and Knee.
Can this happen again? Will it happen again?
9 Million Vets-Reimbursement? Maybe yes?
Hospice- Reimbursement?
Don’t ever count KN out! He is in a league of his own.
Will the biggest retailer in the world be on board? LOL
We are now upon the holiday season, it’s all about, Family, Friends, Loved Ones and Health. Let’s all enjoy.
It will happen in the New Year.
Trust this helps.
Tropical
I will post sometime tonight, to let you know the path that we are headed to.
The only thing that I can tell you is that a 510k re-submission is quicker than an appeal process.
Let's wait for the FDA challenge responses that come out later this week or earlier next week.
Srinsocal
510K Pre-Submission meeting is on the way and should happen in the coming weeks with the FDA.
Sometimes things are not as they seem to be.
Corrective actions are taking place.
Trust this helps.
Hi Gramps
Great videos btw. The one that I enjoyed the best was the one you posted when BIEL pulled most if not all the Acti-Patch products off the store shelves in the UK a few months back. Yes, I understand the line of products is now under the NHS umbrella, so no more retail in the UK! I do suspect this action could have conflicted with the sales predictions? One door closes and another opens.
Keep those videos coming.
Trust his helps.
Hi Simpsonly
Now who are the two chains that are coming on board?
Maybe KN will give a hint or two.
Trust this helps.
Reminder, it's Mother's day weekend, enjoy.
Sometimes saying very little means saying quite a lot.
Trust this helps.
Have a great weekend everybody.
Srin
It's also a common practice for the Licensee to distribute free samples of the Acti line to all medical professionals. Marketing, networking and last but not least-"The supply chain"
Trust this helps.
Srin
I would focus on a UK partner to start the ball rolling.
Trust this helps.
Chompiee
Timelines for quiet periods may vary, it could be 30, 60 or 90 day periods. It’s all about impending actions such as inventory, co-branding, marketing, etc. Keep in mind that the re-design of the Smart –Sole was initialized by the licensed partner which states their intentions.
Yes, the update is very informative. Now if we are looking outside the box, we see it different. This is a huge gift to the investors that read the update. There was no press release and furthermore, there were no Day Traders! Keith is bringing share value to the investor for life, not just for a few days. Keith is not here to bring the stock up just a few pennies, you have to know his past performance to understand his goals and ambitions.
Keith does something the first time which other people would do the second time. Hopefully you understand this.
This is not a waiting period! This is an accumulation period!
Trust this helps.
Bigstick, if that's your name, I remember you as someone else. Yes, you came up here to Toronto many years ago and allegedly started a fire in a hotel room! Correct me if I'm wrong.
You must know that I know that you and everyone else that hold BIEL stock will with certainty and without any doubt be very, very pleased.
Focus on the license fees because those actions alone will take BIEL out of the red.
LOI's are completed, quiet period happening and last but not least, who are the licensed partners? LOL
Rangers and the Devils are hockey teams?????? Hmmmm, got to look into that.
Srin
Hopefully, this will be the last calling card before the great news. Keep in mind that the FDA clearances will go through the 510k process in respect to a predicate device that was already achieved last year. This will be a smoother pathway for all other devices that BIEL submits.
BTW- Do you know which company will get the Smart™ Insole rights?
Hi Srin
Happy Easter to all.
The best that I can say is that-Recovery X was one submission and we received 3 clearances.
How many calling cards do we need to realize something huge is about to happen?
Trust this helps.............
When do you ask, I would say 2 meetings and a fax for body clearance minus the migraine.
Trust this helps..
Hi Simpsonly
The only person that may know this info is-Erin Sanders! Erin is the International Sales Manager for Actipatch. Between Keith and Erin, there is no limit how high sales will reach. I don't believe that Erin will stop and say much in the middle of the race, she is a winner!
Keep in mind partners are happening and licensed ones at that.
The back study will not go in as a new submission, it is included in the knee and ankle submission so this will happen quicker than most would believe. Well actually the back study will be added to the prior submission, I don't want to confuse you.
Trust this helps.
Hi Srin
Watch how huge the Co-Branding gets. How many names besides Pain Gear?
https://lnkd.in/eWrgGXc?lipi=urn%3Ali%3Apage%3Ad_flagship3_detail_base%3BNv3Us1%2FsQXyilhKfSKcP9Q%3D%3D
Talk soon
Hi Srin
Trust you are well.
Increasing shareholder value=7 components of shareholder value.
• Revenue
• Operating Margin
• Cash Tax Rate
• Incremental Capital Expenditure
• Investment in Working Capital
• Cost of Capital
• Competitive Advantage Period
Within the next 120 days BIEL will have in place-
Full body clearance minus the Migraine, anticipated clearance at a later date based upon the fact that this is a preventative study and the patients must have signs of a migraine coming, this study is a little more complicated.
Licensed partners (Major)
Equity partners
At least 2 huge retail chains
Let’s add on a few more distributors. Why not? Lol
NHS-first week of April, keep in mind not the only week, this is lifetime!
There will be other EU States that will duplicate the NHS and this will be coupled with licenses being sold to partners. What price, how much in royalties will soon be determined.
The August financials will and should be the strength of evidence that a certain person has established a supply chain that will be second to none.
Talk soon.
Hi Srinsocal
Trust you are well and hope you are looking forward to the Super Bowl.
Great predictions on Q4, Q1 and Q2 sales predictions on the BIEL board. There are a lot of positive posters on the board that make reading very interesting.
I should mention that sales make up only one component of the revenue stream, this is where my opinion may differ from the good posters on the BIEL board.
Revenue is the total amount taken in by a business in a set period of time.
This can include royalties, license fees and equity from partners and sales.
BIEL cannot have millions in sales without including the other revenue streams mentioned above.
My revenue forecast including sales may be different than others.
Talk soon.
Hi Coach
It's been a while, trust you are well.
Great rewards will follow in due time. Waiting on the FDA protocol. Which means pre-submission. Guidance, rules and timing will be part of the protocol.(Looks like May-June clearance.)
Migraine clinical results will still be the huge one for the FDA protocol.(August-September clearance on positive results.)
NHS is the first of many EU States getting on board. Pretty good health systems across the pond. Sweden next!
You kind of think that a partner has to be on board before a big chain?
Keep well Coach.........
It's too bad that you have a conflict of interest!
The back pain study will obtain US FDA clearance for relief of musculoskeletal pain. Migraine headaches are not musculoskeletal. Migraines and musculoskeletal pain are both neurological disorders. Two FDA clearances!!!!!!!!!!!!!
SEC-much ado about nothing!
Partners-much ado about something!
Not that I would tell you what you already know and if I did know anything, I wouldn't be here. lol
Are you making any plans to visit any huge chains in the future????????
Hi Srinsocal, not that I would give you or Simpson any homework but why not? lol
Slowly but surely the EU states will follow, I guess they don't want to be left behind.
Vi vill idag GRATULERA alla patienter med akuta och kroniska smärtor i United Kingdom!
ActiPatch har blivit godkänd av NHS (The National Health Service) och kommer nu att subventioneras i England.
Detta innebär att alla människor med smärtor kan få ActiPatch på recept från sin läkare.
Vi på Harmony Health Sweden AB jobbar vidare på alla nivåer och hoppas att Sverige inte ligger långt efter.
Trust this helps...................Waiting on Migraine prevention. That's the one to watch!
Srin
Trust you are well.
There seems to be talk about the CEO stepping downing or retiring. Knowing his age, it’s inevitable that it will happen. Sometimes things happen at a certain time for certain reasons. It makes me wonder why a marketing expert is now analyzing clinical results. A great leader would be hands on with everything related to the company. What is or will be his real position at the end? With certainty and without doubt, I believe that this person knows how to run a company.
No more accumulating debt, no increase in shares, this can only be substantiated with a partner or partners coming on board or on board already. I just can’t see a large distribution company signing on without guaranteed inventory on hand. Knowing a little of the person mentioned above, he may bring his own investors on board.
NHS, will it happen? Yet to be seen, keep in mind that most of the EU States if not all do have similar health systems so doors could open.
The migraine study is a preventative trial. Any idea what this could be worth if it actually prevents pain?
Yes, most investors are at a loss, investors are frustrated, investors are angry and given the fact that more info has not been released to the public.
Milestones achieved by the CEO are second to none but to each his own with their opinion and I respect all opinions.
May everyone have a great and safe holiday………………Happy New Year!
NB............Things are not always what they seem to be.
Srinsocal
I believe that there are discussions going on with marketing as well as equity partners. These partners will have a very huge cash position. Waiting on confirmations.
Trust this helps.
Srinsocal
Great reading your posts, great DD as well! Lot of good reading from other good posters as well, don’t want to mention their names, I may miss one or two. lol
Don’t mind the stock price, too many cause and effects including Market Makers, stop losses and so on.
The PR was or should I say was not very stellar! Lot of things were not mentioned maybe because of the timing or better still maybe still in the works.
Now what could be in the next PR?
Maybe-
Application for U.S reimbursements for certain uses now that it is FDA approved?
FDA clearance now justifies strength of evidence for the NHS application?
Marketing Partners?
Equity Partner?
New markets, I don’t see Mexico yet!
New Chain Stores?
Other BIEL products may go through the 510K application but if you would like to read up on Predicate Devices, you may see that the FDA has now opened the door for other products.
Marketing partners will invest millions to get this on shelves all over USA, just curious what BIEL will set the stock price at in exchange for their services. It may be very interesting.
FDA clearance means a pathway to the USA market fully backed by the FDA.
We are in unprecedented times with a really, really great Company.
N.B………..SEC No big deal, it’s an administrative situation not a criminal situation, after the appeal, costs will be awarded to BIEL.
Trust this helps