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That is not the proof i was looking for, its an ussumption. Show me real proof of Bayer giving them the idea for the new tape, sleeve design or the redesign of the device for the foot?
Post the link as proof. If no link - its just an assumtion IMO.
Again, this technology is the best out their by far. Embarrassing that AW cant even make correct decisions to get full muscleskelital clearance because without GP, its a long road that i dont think he will ever win.
The FDA has no respect for the company or the management, after all the things he got caught doing over the years.
The FDA enjoys smacking this little company around as they continue to protect big pharma(.) period!
What position do you think Bayer would be in today, if last year they did NOT choose Monsanto, and instead got 100% involved with BIEL - because they truly understood the technology.
Simply put, this is the biggest game changer in medicine, and Bayer had the chance to take over the controls but didnt. In my book that an awefully bad decision they made, AND I STILL DONT EVEN THINK THEY KNOW IT. Thats how incredibly iggnorrant that company was in reaching this decison.
Again like I said earlier... R.I.P. BAYER!
By wasting tons of time at BIEL HQ looking tavthe books. Why else wpuld they be looking for so long?
Show me any proof how you can give that credit to Bayer. After what Bayer did, leading us on for a long time, they deserve what they did to themselves by simply trying to be too sharp. I cant think of any company that takes that long of a look only to go the other route, and within months have their ass handed to them, like whats happening now with Bayer.
My point was Bayer could have gone either way, and they decided to go with Monsanto.
Imagine if they really knew what we know, as far as how incredible well the product works. Maybe if they ponied up some money to get the big time attorney's again involved (GP), they could have had a much better understanding of this knew technology. But they thought they were really being sharp by choosing Monsanto and bot BIEL.
I think we could have been well on our way to a much different result if Bayer made better choices. AW was extremely congenial with Bayer over a long period of time. I can't think of a better example of what just happened - HUGE mistake on Bayers part.
I bet they wish there was a way to not have to disclose this info. Reality at this point has to be taken into consideration.
Without GP navigating us thru this embarassing situation, and taken into consideration that after we got approval from the FDA for plantar fasciitis and the knee, we decide not only to not advertise the knee or foot product [heres where the dumbest thing i've ever seen tales place], AW takes the foot device off the shelves, as Bayer pretends to be interested in doing business with BIEL. We just got FDA clearance and they remove the product, and here is where the incredible arrogance rears its head again, they dont even hint at why they removed it from being sold online, and its still not in CVS.!?*
I cant blame AW for Bayer perhaps making the WORST DECISON EVER, when they decided to purchase Monasto, and walked away from BIEL.
Ponder on this for a while, maybe the underhanded way that Bayer conducted itself with BIEL resulted in their craziest acquisition of Monsanto. Maybe if they just played their cards above board, and maybe just taking a deeper look at the cutting edge technology that BIEL really brought to the table, Bayer wouldnt have to get their affairs in order as the ultimate death spiral has now begun.
R.I.P. Bayer
https://news.google.com/articles/CBMiO2h0dHA6Ly9mb3J0dW5lLmNvbS8yMDE5LzA1LzE0L2JheWVyLXN0b2NrLW1vbnNhbnRvLXZlcmRpY3Qv0gFGaHR0cDovL2FtcC50aW1laW5jLm5ldC9mb3J0dW5lLzIwMTkvMDUvMTQvYmF5ZXItc3RvY2stbW9uc2FudG8tdmVyZGljdA?hl=en-US&gl=US&ceid=US%3Aen
This is why we should have never submit a 510(k) withilout GP. Your point about the lack of people who know about this product simply enable the FDA to continue slapping AW around (I'm beginning to think they [FDA] enjoy this part).
This could not happen with high level attornies who also used to be in the top tier of the FDA. They already know where all the bodies are buried, so they can speak on an even level with the FDA current top tier.
This is how it works but AW thinks hes gonna teach them a lesson and save money by not having GP represent BIEL. This is the very reason in my opinion he should step down and give the helm to someone who has more experience in the part of the process. I appreciate his tenacity to persevere this far, but he has now bumped his head and has nowhere else to turn.
Remember last year when he said they had to hire a consulting company to help navigate thru all the companies that were contacting them. (Not even one hint at what happened there).
Once we get GP to finish the FDA approvals which are needed to get the deals with the big box stores, because they simply cannot be sold without clearances (muscleskelital being the most important because it also include the entire back from what i've read), then hopefully we will also have an incentive in the deal for the retailers to begin an advertising campaign.
Once the advertising campaign begins we should see an immediate uptick in sales. This is where the real important part kicks in, the social media... twitter, FB, instagram, etc. And also keep the website current. If we already have a functioning social media base that can get excited and continuously keep the conversation not only moving forward but also EXCITING, this has a chance to take to medical community by storm. Well thought out strategy that continues to escape our fearful leader AW, who doesnt know what his next move should be.
Just very sad that someone can continue to make the same mistakes over and over again but still cant learn from past mistakes. Instead continues to act stubbornly just like a child.
Lets see if we can hopefully see anything positive in this next report, even though it continues to be NOT AUDITED... smh!
Only one thing left to add to this... TACT
Actipatch Rocks and you know it does.
AW - not so much
We both agree, this has to be the only way this product never gets to market, because AW near sided founders syndrom...
A PATHETIC EXCUSE FOR THIS PRODUCT!
A bigger man would admit they're in way o er their head and hand off to someone they trust. Not are - LITTLE BIG MAN - he just continues to waste time by not bringing the band back together. Admit you made a huge mistake by not understanding the depths the FDA will take to defeat your character. In other words, grinding out this approval is going to take forever, continuing this path.
WE DESPERATELY NEED HELP AT THE TOP
Penny, IMO we would already have approval if Andy could just stay the course with the dream team. But he thought he learned enough after gaining two approvals with their help in 2/17.
Again, Andy seems to jump the shark every time.
The main reason I think they should have stayed with the dream team is becuse I expect the approval process to become even more difficult now that the FDA knows that he's navigating thru this difficult terrain alone (the FDA can use any excuse because Andy has NO BACK UP), FDA is about to be knee deep in the fight to keep big pharma on top.
They expect this fight because they see how close HEMP/CANNABIS is to becoming recreationally legal, ending the prohibition (people will self medicate because their are less side effects from
H/C). Now dozens of electricueticals about to hit their desk for approvals, things are about to change bigtime for big pharma. Don't worry, the FDA will be right their to prop them up when they get blindsided.
I look at the FDA as the blanky for big pharma. If only Andy had better skills at navigating thru this, obviously he doesn't.
When using on my back, I also bought several compression T-shirts. I had snap ribbons sewn onto my shirts in several locations so I just snap the loop into the shirt so it can't fall out, (I've lost several when training on the field back when I was only using tape).
The compression from the shirt keeps the loop in place, and again, the snap simply eliminates the possibility of losing the loop if the tape failed once I started to sweat). Again, the product worked even better because the entire loop was touching skin all the way around. It was just trial and error, and it just works much better.
Remember several months ago the new surgeon general said to no longer use ice compression after an injury, he said we should eliminate ice, and just use compression. That's when my light bulb started to brighten.
Trust me, using good compression sleeves or shirts when using the loop simply improves its efficacy!
I am very happy they decided to finally adapt the compression sleeves, and adding the logo was a great boost too.
Why? Without question this product works MUCH BETTER when the wire is completely touching the skin. I struggled forever using the loop on my tennis elbow, as I was using a tennis elbow guard to keep the loop on and tape would fall off once I started to sweat.
The problem I discovered was that the wire that wasn't directly under the loop would CURL, making it not even close to touching the skin (more than 6cm). Once I bought some inexpensive compression sleeves, it became much clearer to me that the wire must be compressed to the skin for much better results.
I hope they leave well enough alone at this point and just focus on co-op advertising with CVS and others (I hope their really is other big companies that are in discussions).
Question is, will AW allow this. I agree its a great move to FINALLY start attracting some attention to the greatest change in medicine in my lifetime.
Certainly hope he doesn't misstep here too, but his past performence doesn't bode well for us. He wants to control everything and IMO has a very limited ability to see things from OUTSIDE THE BOX. He's kind turned into almost some type of hoarder of this device - "my way or the highway"...
It hasn't worked so far... but hopefully this will be the change in the right direction...
I have never been a fan of GMO seeds. Leave the seeds the way they have always been before Monsanto - NATURAL!!!
I am still hoping that they find Monsanto at least partially liable. I've never liked anything about that company.
This is becoming very intriguing???
https://www.ewg.org/release/trump-epa-sides-bayermonsanto-over-science-claims-cancer-causing-weedkiller-safe
Stay tuned!
https://amp.cnn.com/cnn/2019/04/30/business/bayer-monsanto-roundup-shareholders/index.html
I dont think Bayer can survive, I also think that Mondanto got away with murder. I hope they are held responsible for this at some point.
If Bayer wasnt so bogged down in lawsuits up to their eyeballs, they'd be able to see this really is the only way they can possibly save tehire company. Buy this on the cheap from Andy and put every ounce of energy into the greatest change to medicine - Actipatch!
Here is a clear opportunity to showcase what a huge and horrible decision Bayer made when deciding to move on Monsanto over Biel. MONSANTO deal will ultimately bankrupt then IMO. ACTIPATCH deal (if aggressively advertised) would still be able able to benfit them Bigtime.
At least we'd salvage something out if this mess and then have hope that Bayer will take us all to the promise land.
A compression sleeve while wearing it on my elbow helped heal my tennis elbow(s)... both of them.
Prior to using a sleeve, I was using tennis elbow guards, ace bandages, tape and it never made a serious improvement until i bought a cheap sleeve on ebay. After 6 - 7 weeks, both my elbows were feeling 100%.
I even bought a bunch of compression t shirts and a couple long sleeve compression shirts as well. I tape one to the back of my neck everyday and wear a compression shirt (keeping the ENTIRE wire touching the skin). I even took the shirts to a tailor to sew ribbon snaps inside the shirts. The stiches eventually broke away from the shirt so im using glue now.
Since I've switched to compression devices to keep the entire actipatch wire touching the skin, i've noticed it works MUCH BETTER than not using compression.
What types of injuries were they?
How did you affix actipatch to each injury?
How long did you keep Actipatch on each injury?
I hope you can understand how important these questions are for the new people who just discovered how amazing this really works.
Your comments confuse these new people, so by answering just a few questions, they might be able to help you get better results.
Do you think the FDA would have still brought up that point about Actipatch working better on women vs. Men as the excuse to NOT give the FDA approval of GP were representing us. Seriously!
I DONT THINK THE FDA WOULD'VE EVEN TRIED TO BRING IT UP IF THEY SAW WHO WAS REPRESENTING BIEL.
This is NOT a knock on the BIEL team, it just proves what lengths the FDA will go to continue to protect big pharma.
We need THE BEST REPRESENTATION to get the full approval.
Even if they get approved for women, they will still have to continue their dialogue with the FDA to get it cleared for Men. Thats still gonna cost more money, which could've been circumvented if better ADULT decisions were made [LAST YEAR]!
Let me ask just one important question...
Q: Who made the decision to file the 510(k) application a SECOND time without GP representation?
Then ask yourself why?
News flash Art...
The FDA has ZERO respect for our CEO. We must change course immediately and BEG if we have to for GP to finish what they've started. To me it seems like a challenge from the FDA for BIEL to make a more legitimate case for this to be given full clearance.
Got to spend big money to make big money.
As the FDA see's NO representation from GP, expect to see similar results.
Its still not too late to ammend the current submission, and bring GP back to the table and GET UR DONE this time...
Exactly right. This is the EXACT REASON, IMO, our inexperienced CEO should have had the DREAM TEAM at the table.
Do you think the dialogue may have been different when they saw who they are arguing with? I honestly think just the PRESENCE of the Dream Team would've had favorable results. Of course if they still raised that point, about working better on women then men, they would've gotten another free education.
That's a good description of what happened Penny, SABOTAGE. A very good point too, the meeting prior to the 510(k) submission would have brought that up and would have been squashed because now they have to reason with people who were in their exact shoes not to long ago. GP would understand that angle being played immediately.
The people at BIEL are very good at what they know, but if we all really believe the FDA will continue to protect BIG PHARMA (sugar daddy), do you still think we can navigate thru this without GP?
The course I've witnessed doesnt seem to make sense. Thats why I continue to suggest BIEL is running scared. These desisions that are being made dont make SOUND sense. It seems we are just treading water...
When the decisions being made begin to make more sense, that will be the tell all for things about to change IMO.
At what point do you think someone at HQ will contact CVS and suggest a co-op advertising campaign? At least they would be trying? Even if the just start having the Actipatch listed as a red hot buy in their newly remodeled wound clinics.
If they get any traction they could include it on some radio spots and then ultimately tv commercials. Does anybody here think any of these conversations took place yet? Just making a point that thinking outside the box is NOT our strength.
By trying to advertise to their (CVS) customers instead of shareholders on message boards just might produce sales that are far greater than they might think. Ot would at least be a real attempt to attract sales and BEGIN BRANDING ACTIPATCH!
The FDA muscleskelital denial last year was a serious blow, I agree. I also think that blew the many other opportunities that would have come along with the approval, because it would have the FDA APPROVAL.
Without that approval, stores are now scratching their heads wondering of the efficacy is really there. It made the task of getting it on the shelves of major retailers almost immpossible.
Even if we get this new approval, I'm betting that stores are still going to be scratching their heads when they read that it only is approved to be used on women? Not men and women!
I hoping for a major turnaround, but that can only seriously start when an adult takes the helm and shares the new strategy, instead of being a Sleuth, still trying to get to market for 12+ years of learning how to be a CEO on all on our dimes.
The product is incredible and its sad to think this may never get its day on retail shelves the way we all imagined...
Still not too late to retire... HINT
Refresh my memory, what injuries did you try Actipatch on again?
How long did you leave on each injury?
How did you keep Actipatch on the injuries?
I hope the government goes back after this family with the long arm CLAW BACK! They were not concerned at all about the danger it posed, only about ways to increase the sales while they knew of these risks this drug posed.
That family deserves what they're gonna get when they blow this story wide open. Can't wait to see if this unfolds the way I think it's already unfolding.
PATHETIC!!!
Here is more news about how dangerous ibuprofen is, including JOINT DAMAGE. Not a good idea for joint pain once you hear this.
https://landers.unitednaturals.com/actifull/?source=39&s4=d45cebb6-f8ec-4348-810e-6c5d7fb9c28c&s5=6b47cc75bec240459535569c33d657ab
How many and what were the injuries did you try actipatch on?
How long on each Injury did you leave it on for?
How did to secure Actipatch to each injury?
FYI - my entire extended family have been using this on all types of injuries, SUCCESSFULLY: ankle sprains, road rash, headaches, bruised ribs, lower back pain, shoulder pain, tennis elbow, dog bite
AND
I have also used actipatch on all sorts of injuries my German Shepherds have. (Can't tell you how much this saves me not having to take them to the vet).
Bottom line, Actipatch works.
I'm as frustrated as you 7. I still believe it is not too late to bring the GP DREAM TEAM back to the table to finally get FDA approval for this to be used on BOTH MEN AND WOMEN.
I think the top tier at GP has a different dialogue with the FDA, compared to the dialogue the company has without GP representing BIEL.
FYI, PEMF has been used on all types of pro athletes for 20+ years. The machine they've been using is more powerful than actipatch.
That's why this is a no brainer in my opinion, because now 20 minutes on the more powerful machine can be replaced with actipatch...
20 minutes of PEMF machine is equivalent to 8 hours of actipatch. Because Actipatch is so lightweight, it can literally be worn 24/7 and I highly suggest using a compression wrap to keep it place. Now imagine it's world series time, the series is tied 3-3 going into last game. Both pitching staffs have been exhausted... can you imagine the PRIME TIME media interviewing pitchers from both sides.
[I imagine that the staff from both teams would be sitting In the training room waiting to log their entry of when they put on the actipatch].
I hope BIOELECTRONICS has towels made with their logo so when they are interviewing them with their arm wrapped in BIEL towels. That's what I want to see this October]
I'm a huge Dodger fan since I was a kid. Oral was one of many ACES back then along with Fernando, Alejandro Pena and many others.
With the earlier post about NOT icing injuries that are inflamed, and the surgeon general warning last year to use ice on Inflammation, NOW would be an ideal time (SPRING TRAINING) Art, for some young pitchers and possibly an appearance from Oral at spring training with a box of the trial loops.
Here is my suggestion:
KN gets In touch with Oral, to see of he would be willing to bring a box of say 50 trial loops, and give them to the training staff. Have a power point presentation already loaded on his laptop. Show the players and the training staff this new technology, along with the headlines from the surgeon general last year: Icing Inflammation is no longer suggested, instead they suggest just a compression wrap. Oral can suggest using the loop under the compression wrap and then they can evaluate the outcome.
TIMING IS EVERYTHING. This should be Introduced in spring training, so that when they realize this works the level of pitching is going to make the pitchers look incredible. Advise to home run sluggers, get in the cage more, because the pitching this year could be incredible.
FDA Keeps A Database Of Medical Device Injuries Hidden From Doctors And Public
I don't want to sound overdramatic here, but it seemed like a cover-up."
https://www.huffpost.com/entry/fda-hidden-report-medical-device-covidien-medtronic_b_5c82b680e4b048b2ab56e3d3
Does anyone know if Oral has ever tried putting an actipatch on the arm of a pitcher after the game - instead of wrapping ice bags on the arm in a towel.
As a monster pitcher for the Dodgers, he must certainly see the value in this product for that use. I think it would be cool for KN to reach out to him, and post some results on some of the young GB up and comers, and what they had to say about it.
I remember at the end of last year the surgeon general putting out this exact same statement. Icing inflammation prevents blood from rushing to the area injured and does not reduce inflammation, the cold instead just reduces the pain from the injury.
DO NOT USE ICE ON THE INJURY WHILE USING ACTIPATCH. IT WILL NOT HELP HEAL IT FASTER.
People who are already addicted to opioids will probably NOT find relief using actipatch, because pain is just the excuse to get the drug. They really have no pain, their just too far gone into addiction from whay i've seen.
But wouldn't it just be easier to do business the right way? Anything else is disingenuous to the long time shareholders who have still hung in their why we all watch our TRIAL & ERROR CEO continue to try to navigate us thru this ultra difficult terrain.
I know that in order for the big stores to be able to sell it we need the full clearance that we should have had last year. In order to get that clearance, we need to the best representation we can find, we had them in the previous submission which resulted in two clearances in 2/17.
Let's all email, call to find out exactly what they can say to refute the notion that this product works better on women than men?
Because they dont have that answer, they go ahead and file yet another 510(k) for women only? (To me that's running scared to death)...
We all need to understand the reasoning why they have failed so many times in the past, HINT: all of our troubles result in poor decisions / planning.
IMO, we have world class game changing medical device that desperately needs help getting to market. Time is running out which is why this perplexes me so much, I would think AW would like to yield some profit out of this company in his golden years, but hard heads come in all shapes and sizes, including the ones who dont give a damn for their shareholders who've done an amazing job keeping there frustrated eyes on this company.
I can only hope that AW may give serious thought to stepping down ASAP, so we can try to turn this thing around. Competitors everywhere with extreme similarity. Time will run out for us before this patent expires.
Serious leadership needed like yesterday.
https://www.npr.org/sections/health-shots/2019/03/04/689739642/fda-tightening-regulatory-requirements-for-some-medical-devices
This just came out this morning. More reasoning to have the dream team discuss the 510(k) with FDA.
Because of the fact that top tier at GP used to be top dogs at FDA is the very reason we need that type of top tier representation. Simply put, these TOP TIER attorneys can have discussions that our team just cannot have simply because they dont have near the experience needed to have those types of discussions.
When the FDA said that they see this works better on women v. men, (I wish GP could have taken that opportunity to talk back to the FDA in a more appropriate tone) questioning how they came up with that, and then they can lead the conversation from that point. We simply cant do that without that type of experience.
That's how the previous 510(k) would have gone and the results IMO would have been different. We would be on the path to make money.
Without them - just spinning our wheels why they continue their trial and error strategy. Many missed opportunities that we simply cannot afford to miss, but we still are because our leader has a new strategy this time.
Frustrated, just my 2 cents.