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And yet we are waiting for some positive news (FDA, NHS, SEC) and have been here since 2011 (some are here from 2009). What made you think otherwise after buying 58 million when all the longs like us were waiting and have so much of confidence? DD? Stocks moves on news and that too OTC's. Things like FDA's decision is a make or break situation and again on DD
Were you the one who spent all your money to buy BIEL 3-4 years back and posted here? Great confidence and faith in products. Just have to wait for the good time which is sooner. Go BIEL
2016 or 2017 first quarter for a decision. But I could see few staying here until 2030 raising the same points which were proved wrong and claims that have no proofs
What's 13,000,000,000 x 0? It's the claims with no proof but just speculations. Wait for BIEL to succeed/fall very soon. We are very near. Long and strong
I agree with your post. There are folks on both sides extrapolating, speculating stuff without proofs and also trying to force their opinion as fact. I believe BIEL is in better position now, forget history everyone has a past but who overcome those mistakes and difficulties will stay and see success. Some big names showed confidence on their products and we can see it all over. And the final thing very soon hoping for a decision from FDA, NHS and SEC
Ohh is it that's very very bad on BIEL's part. Lookout for ask I am letting off my shares. Congrats You are successful in your job.
It's your opinion with no proof and failed to answer my question in precious post. Even if 100% says it works, still FDA has to go through a lot data, follow the protocol and fully be satisfied to Approve. Right now they are taking time to review the data based on broad Usage of the product for various areas of body. Please don't rub your speculation as a word from FDA else show the proof in writing from FDA?
I wish that all these predictors could have predicted about Samsung devices before they exploded instead why pink sheet?
And you mean that Actipatch doesn't have even any success rate and not even 1%? Did you see the studies BIEL submitted to FDA, the reviews on FB and many more reviews on various Pharmacy sites who bought the products? Well it clear that you intention on BIEL is different and have an agenda for blinding all that feedback. Isn't all the above feedback statistically significant?
It doesn't mean that your's or my opinion won't be in consideration, there is an agency called FDA to do that work and they are in that process f studying that. Please remember that no device or infact nothing is 100% perfect and even if the device or drug works and is a life saver for even 5% of the population it will be taken into consideration. Example, recently FDA approved immune drug for cancer that will work for less than 1-2% of all bladder cancer patients.
So sad to see such remarks when a pink sheet company is adding Big distributors names everyday. When such an experienced list of distributors all over the world have belief in BIEL's products here we are simply ignoring the expansion. BIEL could simple add 2nd or 3rd grade or even some unknown distributor but having the belief of BIG names says it all.
Ohh my, you posted a letter that was from 2012, thanks for not posting a letter which Whelan received in his high school. We are aware of the things happened in past but with recent advancements we are very close to a "DECISION" from FDA, we were never so close in the past and no meetings with FDA. FDA sent that one in 2012, the same organization is looking into the application, meeting them often, accessing their data. I will be proud if I am part of this new generation proven application and when it reaches to masses. Check the below video, it is extremely disturbing
https://www.facebook.com/ATTNVideo/videos/1600877930217162/
IMHO: Please speak honestly and precisely regarding your DD when informing board members. This is getting to be very disappointing,
thus listening to all this rhetoric, or maybe I should say disinformation.
Check the below video how bad the drug addiction in US is:
https://www.facebook.com/ATTNVideo/videos/1600877930217162/
Sorry srinsocal he may not be able to provide a link or email as FDA sends confidential updates to only those usual suspects and they were not allowed to put in public but can only discuss
As the topic is also Ultrasound. I would like to remind of a recent advance s in application of Ultrasound.
1. Scientists were able to wake up a COMA patient using ultrasound technology and he was able to regain in a very short span of time less than a month. They are planning to wake up more people.
2. Also Ultrasound was successfully used to deliver drugs directly to brain faking the blood barrier in brain. This is a great advancement in science
How many would have thought the key for COMA and drug delivery is such a simple one and that too with regularly used device?
The branch of Bio-Electronics is now under a serious consideration that BIG players like GSK, Google, Pharma's are concentrating where BIEL already made their impression with Actipatch etc and were lauded by many, proved to be effective for a very good percentage of users. It took so many years and so many studies to convince FDA to clear the device which hopefully will be soon. Given that Big names like B.Braun, Oxford, Boots, Llyods etc believed and customers are satisfied it has chance to make it big once cleared as it will give BIEL more funds and platform to bring out many devices.
Wow a post full of facts. Please sticky this thread. I wish your efforts get paid off. The usual suspects may not qualify to understand this high level,factual and informative type of DD. Probably need an Actipatch for headache.
Check 86969
Please do your DD, again wrong. Regarding predicate you have too many contradicting statements, The mechanism of action is what FDA checks for and regarding the pulse wave it is similar to you call as dosage for drugs. And I guess that is not at all a problem. Regarding the FDA approval and pathway I would wait and dont want to speculate like you do without proof
Don't think so. The pulse and frequency depend on the part of body. Usually can't apply any PEMF to neck similarly it is different for different part of body
As usual false statement. I think the study is terminated, it is not completed to either prove the efficacy or inefficiency. And one more thing I observed is they used Actipatch instead of using Recovery Rx(Not sure if it was there at the time of study). Each product of BIEL like Actipatch, Allay, Recovery has different kind of pulse wave frequency depending on the part of body. So, it's not a failed study but could be asomething with funding
Yes, I have that confidence. I believe if this product is not a potential one the big names (B. Braun-NHS, AS.Watson, Boots, Walgreens, Goodwin procter, Oxford trials and many more) won't associate. Waiting for that one thing which is around the corner
They are already aware of BIEL and its products. There were many articles posted here mentioning about BIEL,GSK and the future of Bio electronics branch of medicine. My opinion:
1. After FDA clearance there will be huge competition for buy-out
2. AFAIK already there were talks with big companies for a partnership, current distribution network gives you a picture
3. Even if FDA doesn't approve(faint chance) there will be a deal from Big Pharma as there is no R&D but a finished product, and they can influence FDA for Approval.
There is a chance that they influence FDA not to Approve BIEL so that they kill it and buyout cheaply.
You have very contradicting statements with no proof's and doesn't match with your other statements. You keep saying there is no predicate device in some posts and in another you say there are lots of devices like Actipatch and BIEl cannot compete with them, so why BIEL? Unless with an agenda all your statements doesn't make sense. May I know why?
And with expedited process hopefully we will get it by Thanksgiving or by Christmas, would be the best gift in the stockings.
As usual false opinion. BIEL already submitted UK registry study which is a RWD and it has lot of papers and studies done and mentioned on the website. Moreover Oxford study is due, I heard its completed and very soon we will get an update, it will play a major part in NHS Approval
And you forget the usual suspects old saying that they don't believe Andy and his PR's
Yes we like the PR but still the facts not satisfying for few. Today's PR is pretty clear BIEL trying to get approval for numerous areas of pain and FDA asking to provide more and more studies else will approve for whatever studies they have
True but that itch to know the most important information that decides the Fate of the application and getting that positive news from World's best university is equivalent to spending a billion on marketing.
Well any hint of the outcome. Based on the tone and excitement we could draw some conclusion
I have an email from Paul sometime back and he told me they are no longer with BIEL but he suggested that BIEL has good product's. It was posted number of times in the DB
Have any update from the company regarding the Oxford study and NHS?
Sorry Paul is not anymore with BIEL. Grace is taking care of PR stuff, Paul is with E&E.
I wish they could have added some information about the oxford study as it is very relevant at this point of time. Does anyone have update regarding Oxford and NHS from company contacts?
As expected the unhappy shorts and MM's will play their games to scare some impatient investors to sell. Beware don't fall as prey and lose out.
Show me where FDA rejected the current application? Speculation or agenda? Why FDA meets BIEL so many times in such a short time? Why does FDA ask for registry data and consider the data available? Why such a big law firm associated with BIEL? And there is no proof for all your speculations. Regarding the FDA clearance, NHS approval and OTC clearance it is still either YES or NO and we believe very soon. SEC verdict is yet to be out. Whatever is said is speculation only. If SEC feels BIEl has done something wrong they will be fined but until verdict comes everything speculation.
Please follow all the posts recently lots of wrong statements and proven wrong
But all the negativity sorry reality is consistently proved wrong on so many accounts and all the speculations were still the same missing the dates provided. While BIELevers are waiting for APPROVAL since many years and aware of denials earlier, has lots of faith on the technology and strongly believe that BIEL is closer to target(OTC approval). I firmly believe that BIEL didn't back out but tried all the time explaining and proving FDA that an alternative for pain and drug abuse is the need of the hour.
.0008, 8's printing
.03, 3's printing
.30, 30's printing
LMAO. Meanwhile BIELivers buying and adding more
Ok whichever way it is FDA and BIEL meeting so often is a good sign. Do you think FDA and BIEL meet unnecessarily? If FDA have some issue they could clearly say no instead of meeting so many times
I don't believe that way. When FDA is requesting so many meetings it means good for the company and lots of things going on else why will FDA waste time even for meetings with such a small company.Being in FDA radar and these discussion is good for the application, if FDA doesnt feel the product is not good they could easily reject instead of discussions
Nowhere I compared with drugs and you know and how about this: You keep telling BIEL has to go with denovo route as there is no predicate device and now when the time comes you claim that there are number of devices. BIEL want this technology to reach out to many hence seeking OTC.
A compounding pharmacy has nothing to do with medical devices? Then why you make a huge cry of TENS devices in the stores. Please check your facts, not only Actipatch, infact 99.9% of products in the world reaches to customers only with good distributor network.
Regarding shelf space, every company has issues it depends on the monetary deals with the chains and sometimes the importance of the product to general public.
When so many companies made similar wearables why so many articles show BIEL as reference and why BBraun, BOOTS, ASWatson etc gives importance to BIEL over others. It is sure a winner in hand.
Compounding pharmacies have nothing to do with BIEL??? Pure false and silly statement. How does the business grow without a distributor channel and some of the distributors that BIEL have are in business since decades. How do you justify their choice to distribute BIEL products? Everyone under the sky(Exception is Big Pharma guys and their paid employees) know how Big Pharma's lobby and try to kill a product that breaks into their revenue. FDA accepted the registry data with so many patient responses and you wont believe. You have to understand that recently FDA approved a immunological drug which only works for less than 5% of the affected. BIEL's products may not work for 100% of users but even if it works for 10% percent it is a life saving product. Keep repeating false claims with out proof? I will let FDA decide the the outcome for this 7 year struggle to get approval. BIEL will be pointed out even after APPROVAL because only a tree with fruits be stoned.
With lot of tech companies like Microsoft and facebook freely focusing on health there will be a setback in BIG PHARMA'S monopoly. And even the public is doing their part be using social media for reporting wrong doings. Just some people need to change.