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I hope your right. In the past these runs seem to always end because of something disingenuous.
I hope this isnt another whopper getting everybody's hope up for nothing.
It sure would he nice to get a real update from them at some point. Still doesnt feel right. The 510(k) being resubmitted for women only just drives me crazy, because it's the only thing that works for my bad neck and back.
I personally wish they had had discussions with the dream team to come up with a plan to get it approved for all. Time wasted is causing this company to LOOSE MONEY. IMO, had they already had the dream team in the last submission, I honestly think the FDA would not have the guts to talk to them the way they do, they treat AW and the crew with no respect.
I would have loved to hear the reply from the lead person from the dream team after the FDA suggested that this works better on women then men. The lead lawyer from GP would have SHREDDED THAT IDEA.
Hopefully this takes off.
Product works great, only problem with the company is management. They just dont learn on the job very good.
Trial and error season has officially ended.
Lets urge AW to go home and enjoy the golden years. We need to put real management in place that can succeed. Continuing to make excuses or to hood wink investors again would be inexcusable.
The word immenant by Keith describing Dr. Scholls, and the way they lead us to believe it was going to fly just proves incompetence of the entire team.
That's what we get for continuing to pay tuition for AW. Its become far worse than I ever thought it could. Do they really have this poor of a management team in place.
It feels like they are running scared, not knowing what to do. Not good.
GET GP BACK INTO THE MIX OR WE'RE DOOMED!
That's the reason we need GP to represent us throughout this process as we are clueless in this area, mainly because we have no idea far the FDA will go to protect big pharma. And because paying for AW to learn on the fly has proven to be a failure. Be happy we got as far as we did, however the company would love to co tinue to use the EXCUSES route because this management is best at playing THE VICTIM.
In fact they are not victims, they are scared because they are sinking because they are in WAY OVER THEIR HEAD, as their decision making abilities still have not improved at all. Puzzling!
Seems obvious they are running scared... CLUELESS
Make the right move and soend whatever they can to bring back the dream team, if they will even work with them again?
There has been plenty of collateral damage since the FALL FAILURE. Time to smarten up now, or get trampled on with one of the biggest failures of one of the greatest new technologies to reduce inflammation and manage pain WITH ZERO SIDE EFFECTS.
GO FIGURE.
Amazing this never turns around.
Scared, clueless, and most here still stand up for one of the all time worst management in the penny stocks when all things are considered...
How about an official apology for not being sharp enough to being the dream team to the FDA meeting and ride along side thru the entire process of getting all products approved.
This admission may give some the strength to gut it out again, knowing this time will be different because GP is involved. It takes mo ey to make money. Stop pretending to begin a marketing campaign, and spend the money on GP. From what I've seen, this company cannot begin marketing without FDA clearance of the entire body, and that should have already happened if the attorneys were along side team Biel throughout the ENTIRE process.
Nothing is going to be different, the FDA clearly has zero respect for AW. They will continue to treat him any way they feel because they know he is in WAY OVER HIS HEAD!
Was hoping for a better effort? This will probably do more harm than good even though it was a goof.
Bad idea jeans
We should also ask management if we can list the product for sale at CVS/Target on the advertisement.
Need to be very selective of who is really looking to help. Certainly not the usual suspect that I won't list because well get pulled down.
Mark John, just for kicks, could you show us what the advertisement might look like on the upper portion of the big side windows in the back of Suburbans Tahoe's Yukons.
$1/day pain relief zero side effects. No pills.
(Actipatch logo)
(Local Phone for people to call for info)
Well I think it's time for a change. I for one refuse to dump more money into this after what I saw just happen. But to your point, we need some effort in marketing the knee loop with wrap like they are selling at CVS. Since we've gotten both approvals in 02/17, there hasnt been any noticeable increase in sales. After looking back at this and thinking about it, this really has been an absolute EPIC FAILURE since those approvals. I would've thought the knee loop with sleeve should've been out there for sale within weeks of the approval.
We do this until we attract serious attention, then the product starts to get noticed by more people simply because it really works. All the time we are selling these, we should be also working on the next step. What do we do next after everybodies talking about it, without the next steps being considered, it will fail as well. Let's get a leg up this time and really start some GRASS ROOTS MARKETING. WHY - BECAUSE IT REALLY WORKS, AND THE COST IS ABOUT AS CHEAP AS IT CAN POSSIBLY BE.
Let's keep this discussion moving forward.
Add ideas and let's see where this goes.
What If the longs started to buy product and have windows or their vehicles partially wrapped with an ad advertisement about actipatch? We could have Gramps make up the graphics and send to Biel for approval.
Imagine sitting at a stoplight and the car next to you honks after reading the advertisement:
> Ask me how you can live without chronic pain, without taking pills and ZERO SIDE EFFECTS for less than $1 per day... <
You roll down the window and the other drivers in disbelief. You both pull into a parking lot and before you know it you just made a sale (these salespeople should have both the trial loop and the 720 loop available for sale).
Before you know it we'll be hanging outside large stores who dont sell it yet and the advertisement is getting everybodies attention. Now think about how many of us BULL LONGS there still are out there.
My point is if management continues to make HUGE mistakes (like going it alone without GP for FDA approval), the patent will eventually run out. At least this approach doesn't cost tons of money, the investors will pay for the window or vehicle wrap after management approves and advertisement.
I think there is over 250 of us who have the years of experience using the product, and could be very good at starting to move product and get noticed. That means the advertisement will be seen in the public as we're driving.
Feel free to ad to this idea to make it better. Bottom line - no more excuses. We must drive sales to get us out of this trap were stuck in.
??? CNBC is on watch for live coverage of presidents signature of Farm Bill.
Why would you suggest it's already been signed??? I'm watching LIVE TV
President Trump on Thursday afternoon will participate in a signing ceremony for the farm bill, the Agriculture Improvement Act.
The event is scheduled to begin at 2:30 p.m. EST.
Watch the live video above.
Heres the link for the livestream signing:
https://www.google.com/amp/s/thehill.com/video/administration/422285-watch-live-trump-participates-in-signing-ceremony-for-the-agriculture%3famp
https://www.rollcall.com/news/policy/trump-sign-farm-bill-minus-food-stamp-changes
The "RULE" changes 4th paragraph about the USDA changes. Continue from there.
Heres the newest release regarding the farm bill:
https://www.google.com/amp/s/thehill.com/video/administration/422285-watch-live-trump-participates-in-signing-ceremony-for-the-agriculture%3famp
Just hung up with Ricky on Capital Hill in the Agriculture Comittee. I asked if the Farm Bill is still scheduled to be signed today even after the new rule of the USDA.
He said that will not prevent the president from signing the bill this afternoon.
This is GREAT NEWS... about to take that first step we've all been waiting for - for way too long.
They are still working out the differences of the bill. From what I've read, the Senate wants snap program (food stamps) participants to work 20 hours a week and/or get drug tested to keep benefits [like FL]. The house wants everybody struggling to get the benefits without work/drug test.
I love the products, I have reservations about management for several years now...
What ever happened with Michael Lammas & Michelle Sides?
Somehow this is turning into a serious gamble, does the president sign this bill, or will put government play politics with it, and partially close the government.
Nothing is ever as easy as it seems like its gonna be.
Tred lightly and keep your eyes on this ticker every moment the market is open. Can go either way with a big move. Looks like it may have a gap to fill anyways near close to .06?
No confidence in this happening without adult representation. If we try this again without the attorneys, expect the same results.
The FDA is keeping Big Pharma's best interest. Not only are they worried about actipatch, but hemp is about to be legalized, which means people will be able to use CBD to self medicate instead of BIG PHARMA PILLS. Not good for the liver/kidneys.
If GP was part of the last submission, we'd be golden.
Does anybody think we still would have failed securing FULL FDA Clearance If the
Dream Team was part of that process?
How would the FDA have suggested that it works better on women than men with that crew of attorneys present?
I still think we would be continuing the party as I'm confident GP would have been SEVERAL STEPS ahead of the FDA's questioning. This had tons of momentum and it really should have gotten the approval because we all know how well this product works. I really do think this will become the standard in medicine.
Andy's biggest mistake this past round without question IMHO was the decision to go it alone without GP. HUGE MISTAKE..
Hopefully he learned from this mistake, but if they submit again for women only, it will only set us back even further if they lose again? (I'm sorry - but you have to prepare for the worse too). This decision needs a serious discussion before we embarrass ourselves AGAIN and waste even more time.
My 2 cents...
Hemp legalization included in new farm bill could 'open the floodgates' on nascent industry.
https://www.cnbc.com/amp/2018/12/07/final-farm-bill-with-hemp-legalization-could-be-voted-on-next-week.html
I believe this is called the loading zone...
Takes no responsibility at all, they make it sound like it's just a matter of resubmitting. Were they asleep May 9th during the presubmission meeting? Why wasn't this revealed after that meeting.
Never says BOO about allowing Bayer to have access for way to long only to blatantly put that product up for sale. An OBVIOUS Slap to out face, showing us ZERO respect.
You bet I know when, and it AIN'T any time soon. More evidence that he's in way over his head, and it didn't sound like he's going to tap GP on the shoulder for help.
That's the part that speaks volumes to me, they cant get past the FDA without GP navigating us thru IMPOSSIBLE TERRAIN. They are much more experienced at dealing with the FDA. Prior to the previous two clearances back in 2/17, GP was helping us get approval after the FDA had reclassified the product into a brand new classification. Apparently the FDA still doesn't understand PEMF, and thinks they can continue to bleed the money we invest in a trial and error game of submissions. Time lost is the l
part that really bothers me. An entire year gone with ABSOLUTELY ZERO TO SHOW FOR IT.
The FDA is the bodyguard for the multi billion dollar big pharma industry. Without legal representation from a top tier group like GP, prepare yourself for even more mishaps.
I haven't seen that the SEC settlement deadline has past and they didnt pay on time. If that's the case, I can only assume that BIEL was waiting for the clearance from the FDA so the PPS would go up and they could dilute more money for less shares.
When you have a chance, please post the link showing the blown deadline.
Yet another set back.
Sree is great. Wonderful knowledge of the product. Problem here is the FDA no matter what is going to VEHEMENTLY defend Big Pharma (they have for decades).
Wouldn't it be better to have Sree meet with GP before the call to FDA, the I'm lude GP in that call, just in case there is a great rebuttal to throw back at the FDA?
Why hope for more pain? Change management, it's not the products fault management cant market like an adult.
Huge fan of the products itself. I feel bad for Andy to a certain degree, then when I look at this past opportunity, and it simply failed in my opinion because we didn't have proper representation for this opportunity. But after this mishap, no matter what anybody else thinks, Andy should now realize that by not bringing GP to the party, this opportunity never had a chance. FDA has always had a horrible reputation of having BIG PHARMA LIVING IN THEIR POCKET! He needs to to step down immediately.
Is it too late to contact GP and have them review everything that went down. If I were the new management coming in, I would definitely have them review this. Could they possibly revive this denial by having an adult rebuttals for their BS arguement men vs women efficacy.
This product will become SOC with the right team in place, THE PRODUCT WORKS GREAT!
That was my point in my previous post...
Now, 2 years after knee and heel clearance with no attempt to market those immediately after 2/17? Puzzling to me. What did they think was gonna happen?
Two years has past and we just got denied full clearance, what big retailer will want to take a chance with us after this? I hope Keith is 100% involved in day to day with CVS retailing it with the knee sleeve. This product works MUCH BETTER when placed under any type of compression to keep it tight to the skin. Because of that, I expect great results from the CVS chain. Think of this like completing an electrical circuit... the loop penetrate a little more than 2 inches under the skin, so it would be wise to keep it as close to the skin as possible, allowing it to be able go penetrate deeper into the soft tissue. I hope Keith keeps a close eye on the CVS deal.
The FDA denied us, Bayer walked away, but hey, hold your head up, because this time were going to get the musculoskeletal clearance? This product deserves a real fighting chance to be marketed by adults. I hope we get the chance.
Now we have to start the cycle over again.
I hope I'm still alive when this finally gets to market, I'd love to see if it takes off like we all think it will if it ever gets there
Again, this is a horrible miscalculation, and I seriously dont think we can afford any more mishaps.
Seriously? We've had heel and knee cleared for almost two years. We just now got into CVS with the knee, and our management thought so highly of the Dr. Scholls deal that we didnt even try to market it, instead we pulled from all shelves? AND NOW you say we need a bigger player?
Too many excuses, just absolutely horrible little white lies lead us down a path all year long, only to find out that we went thru this entire process without the team of lawyers that could've changed the outcome, that's why they have pre submission meeting May 9, only we forgot part of our team.
In my opinion. This is going to be much more difficult than most of us think it will be, as we now have 25B O/S shares, the price is back to it PATHETIC lows, and were out of money... now the company wants to resubmit without representation again?
I've used this product on all kinds of different ailments. The products has never NOT worked. My sister slipped on ice getting our of her minivan the other day after our blizzard in the midwest. She just missed hitting her eye on the top corner of the door. Her face is extremely black/blue at the top of her cheekbone. After placing the loop around her ear and some tape under her eye and nose to keep it tight to the skin, she already noticed the difference in both pain reduction and inflammation. She kept it on all night woke up and had no pain on her face unless she poked at the injury intentionally. She has no been hearing it for two entire days and the difference is huge. She just cannot stop talking about how quickly this worked for her. My point is this seriously should become the STANDARD OF CARE moving forward, and I'm happy the team is trying that approach, however, new management is our only hope imo.
I never in a million years ever thought that the FDA would deny clearance. Now I'm shell shocked. And the worse part is that it doesn't seem like the company is acknowledging it made some SERIOUS ERRORS in this previous submission.
I think I'm gonna have to seriously lighten the load and cross my fingers that one day SOON well get someone to take the 1 hole if it's not already too late. Serious changes at the top must take place, as investors who've been supporting this for years, we m it st demand this take place.
SMOKE & MIRRORS
NOT GOOD
I wish I could have been a fly on the wall when the FDA brought up that BS point. The Dream Team used to be the previous top exec's of the FDA. Who knows there way better to navigate?
I think this was a very bad decision, going it alone without GP. Now we've experienced yet another set back.
We should NEVER EVER attempt a 510(K) without the dream team present, helping us thru. Most of us dont have a clue of the ways the FDA will be able to continue punishing BIEL as they are really just protecting big pharma. And dont forget, as we're in the middle of an Opioid Epidemic, the FDA approved another Opioid, this one is now 200 TIMES more powerful than the previous most powerful Opioid. (SLAP)
I think if the FDA didn't bring it up (women / men efficacy) during the 510(K) meeting May 9, if the GP gang was part of this process, and they brought up the point that it works better on women vs men, then they would have an opportunity to earn their money. They would have SCHOOLED THE FDA with that BS arguement. They may have even had a better writt. Explanation in the 510(K)
The Dream team was left out to SAVE MONEY. Now looking back in hine site, the SEC money was greatly reduced from its original. If they didnt have to play CHEAP and Goodwin Procter was at the table during this most recent process, we'd have full FDA Clearance.
If we continue this process without GP, expect more of the same, because the FDA makes up rules as they go along.
Now Bayer is selling off Coppertone and Dr Scholls, after peeping thru our books for the past year. Again IMO, we had no idea this could possibly turn out so HORRIBLY BAD.
I admire his persistence and never give up mentality, but a serious change in direction needs to happen here, our just watch our money BURN.
SHAREHOLDERS NEED TO VOICE THEIR PERSONAL CONCERN NOW, if they have any concern at all at this point.
Looking back, isnt it STRANGE that KN used the word IMMINENT to describe the Dr. Scholls deal.
That was the exciting part for me, after getting others to notice this product after the NHS legitimized it, and FDA wanting meetings after the cost benefit analysis was released.
Something just isnt adding up? I am very concerned about this entire next move. Its critical to our existence.
Bayer has supposedly been trolling us for most of this past year. They seen way too much IMO, and the fact that BIEL still has no effort to sell insoles tells me that Bayer has seen what they needed to see, and can string us along as they please because they're so big. Also - we never have seen a LOI from Bayer, did I miss this? Or is that just more "TALK".
Changes at the top are imminent IMHO. Such a remarkable product with so mu h disappointment that somehow continues...
We need the dream team to get in the face of the FDA. They used the excuse that its works on Women better then men.
I'd bet money that if GP were sitting at the table with BIEL after they brought up that point, the team lead would have ripped the FDA a new one for even trying to bring up such a BS arguement.
*** Also remember about 2 or 3 weeks back, even at the height of the opioid epidemic , they (FDA) still approved a new opioid that's 200 times more powerful vs the current strong opioids.
I think the GP lead would have also brought up that point too, and I would hope they would apply more pressure by helping point all this out in the form of a press release bringing all this to light.
Spend the money and let the Dream Team navigate us thru all the FDA excuses. The FDA is big pharma's bodyguard - the Dream Team is ours. Let's see if they still want to play - protect big pharma games...
Why am I the only one who sees thru this? Come on already. Do we want to make money, or just continuing to talk about making money.
The old phrase: you have to spend money to make money - sure applies here.
PURE BUREAUCRATIC BS at its best. FDA is now propping up Big Pharma because when this gets cleared, AND if it ever gets marketed professionally, everybody here already knows whats gonna happen to OTC pills and other FAKE products marketed.
WHY GUESS? or Hope? Bring the dream team back into the picture and IMHO we will get approval much faster? Does anybody doubt this?
This is where the leadership is WEAK! why reinvent the wheel?
FDA has undeniably mistaken this little company as their punching bag for WAY TOO LONG. FDA attorneys at Goodwin Procter are heavyweights. At least have them review what Sree is preparing prior to another submission.
I think its OBVIOUS that the FDA is now in PROTECTION MODE, maybe the big pharma companies are expressing more concern now that Bayer / scholls is in the mix, and a top 5 medical company is at the table (dont know who).
This may drag on for who knows how long, until you bring in professionals that no how to deal with the FDA BS!
Just my 2 cents
I just cant believe the FDA actually used the excuse of it working better on women then men. PURE BS IMO.
When they received FDA clearance on knee and foot in FEB 2017, I remember they finally got wise and hired the dream team at GOODWIN PROCTER. I wonder if they were involved in this 510(k) submission. I also wonder if they were part of the submission of the innovative challenge.
I'm sure they are very expensive to hire, but because of the past history of FDA and BIEL, GOODWIN PROCTER was a great heavyweight to have in our corner.
Does anybody know if they went thru this process on the cheap - going it alone without the Dream Team? Because I dont believe FDA would dare compare the results being different from men than women.
Again, something that was learned, hiring GP, we got foot and in knee. I wish GP was at that May 9th meeting, because I think the FDA takes advantage of BIEL when GP isnt backing them.
I think we may have already started the party if we had them in our corner for both these recent submissions.
Will they finally hold him ACCOUNTABLE? Otherwise he escapes yet again. Must be a very slippery little man! How many times can you lose your pharmacist license before they REVOKE it... Literally?
Heres the million dollar question, Actipatch had to deliver X (unknown) amount of product to be on retail shelves prior to April 1st for NHS launch. That means the product had to be delivered in Q1 (that's why the numbers for Q1 should be significantly higher).
Q: How many units did they deliver for the April 1 launch?
50K units? 75K? 100K? or more. If they were behind the pharmacy counters by April 1st - wouldn't those units delivered be considered in the Q1 numbers? Even if the retailers only stocked two (2) of each device, and the rest were at distribution centers available for next day delivery to pharmacy. All should be counted - correct - Units at retailers and Dist centers?
This is the main reason I don't understand why other longs on this board suggest Q1 may not be as high as I suggest. Can this topic get a serious discussion?
The product just had to be delivered to be counted in Q1, not necessarily already sold to the end user to be counted. I hope this point is understood.
An opportunity of owning a stock like this comes along once in a lifetime at this level.
If you're a baseball fan you'll understand this analogy - What are the odds of going to a baseball game and it turning out to be a GEM; Not just a NO HITTER - but a PERFECT GAME.
That's what this is.
Now ask all your friends that love baseball and go to games all the time. How many of them ever sat and watch a PERFECT GAME IN PERSON?
Fortunately I was able to be at the SOX game when Mark Burhle pitched a PERFECTO GARCIA v Tampa at the Cell. It was Awesome to experience.
Now to experience this erupting before my very eyes, after being in this for over 7 years. I can honestly say this was soooo worth the wait. I cant wait until the multipliers start to kick in. We got a taste of what the multipliers are like on Friday (up 6 ticks)!
I think thats why the also have a May 29th meeting with the FDA. They’ve now seen the NHS COST BENEFIT ANALYSIS. The FDA is now extremely captivated, waiting to hear/learn more about this use.
Lots more to come.
Again - I think the price TODAY should be .005. The market seems to understand this, hence the slow move upward over the last 2 - 3 weeks, then they sent a PR about radio interview and look how quickly the market reacted to that interview. Most here are just waiting for just one of more than 10 possible catalysts could blow the roof off this, going way past a penny maybe even penny and a half.
I think the FDA is about to do an about face, and will very soon be 100% on board with all this devices uses, based on all the GREAT INFO coming out of the UK.
Again, I cannot stress enough what an absolutely genius marketing strategy team BIEL used to gain the traction we now have I the UK.
Ever since the B BRAUN & NHS was revealed in the newsletter, and the new use prior to surgery, and please keep in mind, my numbers are EXTREMELY CONSERVATIVE. The upside surprise to my estimates are very achievable.
Also keep in mind when running numbers, I sometimes wear 3 or 4 loops per day depending how I’m feeling, after all, it’s only $1 per day to use for 24 hours of pain relief per injury WITH ZERO SIDE EFFECTS.
How many others will wear more than one at a time.
Until you actually get off your wallet and spend the $4.95, you’ll still be wondering, IS THIS FOR REAL - or are they just pumping this up.
I think we will always have a never ending beginning of new investors, simply from the number of people in the UK who have found success using this.
1) I think they will immediately discover this really works like they said it would.
2) then they will do a little DD On their own to learn a little more.
3) when they discover this is still a mere embryo, price wise, they will immediately get that great feeling and look to invest in this before everyone else finds out how well it works. Never ending new blood to keep investing in this. Same thing will happen her in the US when we finally get into box stores and big pharmacies.
One added to them After surgery I’m recovery. They go home with one being worn, AND 1 more in the care package, along with a script for 6 more. That’s a total of 8...
IMO - $100M with what we know is going on. That put the share price near 0.005
Until more news - I think that is a fair price. Let’s see how far the market moves is, after all, this move hasn’t been PR after PR, no pumping. Just a slow moving climb up the hill as it balances all this great news just around he corner.
It would also be nice if someone tweeted about the ActiPatch to POTUS.
I would but I don’t use any social media. Don’t trust it.
It seems as if the MARKET DISAGREES with your nonsense posts!
The proof is in the market correction of the price of BIEL - its been going on for over a week, on very little news with the exception of yesterday's radio interview... hmmm
Are you sure about these things in your post? Or are you just looking for a better entry?
Another new HOD - .0027