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I think you know why Canada launch has been severely delayed; it's because the FDA in the U.S. has been severely delayed and because of the FDA sitting on their hands with any kind of medical device unless it monitors your every personal motion and vital sign, or doesn't somehow contribute to the world of big brother and continued health care in the form of annoyances and dependency......that is just a couple of reasons that come to mind. Management and FDA delays are causing further delays and a continued drain on finances..Canada is on hold until then. ImO. One more thing, why are they withholding the date of the next FDA meeting, why not just give us the date already?
YW promaster12. If the FDA does not at least finalize and address the Allay appeal from the BIEL guru/ FDA demi-guru meeting/discussion over 60 days ago - at the next BIEL/FDA meeting at the end of August 2012, then our government is in more serious trouble than anyone can realize - pending new DeNovo category excuses or not. They will have proven that at least one of our government administrations is completely inefficient and ineffective in dealing with serving the public and small business interest. Let us not forget, once again, that they serve US and not the other way around; even the Canadian government seems to understand this more lately than our so-called free world government does. Our government is being run over by self serving individuals influenced by big corporate money and from what we can all see has lost it's way a bit. (For those of you who don't believe it, then just read what half the posts on this board have been saying lately!!!!).
Thanks walker_429. Glad to see you are still around. It appears we are being kept in the dark by the FDA and the company. We never hear any real details of whats going on or as to why the FDA acts like a flapping dictator with U.S. Companies. Not saying the FDA has never done any good, but what has the FDA done for us lately? Oh that's right, they just approved a pill that monitors your vitals and informs your doctor directly from your smartphone the last time you ate and.....you get the picture. This is the last time I invest in a company waiting for 'our' pathetic FDA to give feedback. It's the FDA's game and they don't even know their own rules enough to tell a company exactly what is needed in a reasonable, timely manner. That, and we hardly ever hear any of the mistakes the company has made along the way - except maybe from some privy people who post on this board. (Good thing we have iHub or we'd be further in the dark). In all this frustration of waiting I hope we can all celebrate a victory soon. I'm here until we get an approval. Best to you walker_429!
Agreed. Regarding Actipatch, the FDA has stalled long enough, unless they want another round of the Senator and the IG in their business. Once again Andy and Paul have seemed to have bought more time. The FDA, however, is running out of time though and running out of excuses for not rendering a decision. They have had ALL the applications for quite some time now and have had plenty of time to understand and review the medical devices. Right now, since the FDA has taken so long processing these applications, they should either knock them ALL out at once or let the company know exactly WHAT they need to make a freaking decision, instead of leading BIEL on and on and wasting more time as some one else mentioned. My Advice to DR. MARGARET HAMBURG, HEAD OF THE FDA: YOUR FOOD AND DRUG ADMINISTRATION LOOKS TOTALLY INCOMPETENT!!! HAND THE BIOELECTRONICS CORPORATION FDA APPLICATIONS OVER TO PEOPLE THAT WORK FOR YOU THAT HAVE REAL 'KNOWLEDGE' AND 'UNDERSTANDING' TO GET THE JOB DONE!!!!!!! FDA, YOU HAVE WASTED ENOUGH VALUABLE TIME AND MONEY!!!!!!! THIS NEXT MEETING (BEFORE THE END OF AUGUST 2012), SHOULD INCLUDE A DECISION FOR EITHER ALLAY, ACTIPATCH, OR RX RECOVERY, OR ALL THREE!!! GET IT DONE ALREADY!!!!!!!! EVERYONE'S WAITING FOR YOUR ADMINISTRATION TO PUT OUT SOME RESULTS. (Maybe the problem with the FDA is in it's name - as there is mention of food and drugs, but no mention of medical devices).
To think I had over 1mil. shares in BBDA at one time, but after dilution and R/S I now have 174 shares. Sorry if I didn't help your point GhostCat, but that stock hit a nerve. We are either on the verge of something big right now - or we aren't. "Place your bets!"
@uksausage: Either way, this next FDA meeting scheduled for the end of this month should (or shall I say - better) bring at least 'one' decision, because it is time, and the time is NOW! I also just hope Andy knows what the FDA is going to need - if anything - and brings along his entourage again along with any recent information on Actipatch - no matter what they already told him. I know Paul K. mentioned Actipatch instead of Allay in the update today, but I feel that the final Allay appeal decision SHOULD be given to BIEL at this next FDA meeting. IMO. Get ready everyone! Happy Trading!
@investordisciple: Totally agree, ambiguous to say the least. A couple things that came to my mind besides the unclarity of the update is that maybe if they reverse decision on Allay to BIEL's favor, then Actipatch could be easily approved or if Actipatch is approved, then it seems Allay would be an automatic reversal to BIEL's favor and BIEL should have a double acceptance. There is no reason when they all meet that FDA shouldn't give them Allay decision. The other thing (and very unlikely) was if the Allay decision sticks, then the FDA may give BIEL an opportunity to save face and wants to give BIEL an approval of Actipatch at the same time they remain with their denial on Allay for whatever reason due to Allays application. But as I stated earlier, there's no reason why BIEL doesn't get at least "one" decision at this next meeting with the FDA at the end of this month.
@ghost42, Do you think that it's time for investors to contact the Inspector General and the Senator again? It's been over (60) days since the appeal meeting for Allay and it's been over a year for Actipatch decision. Maybe they could find out a timeline for a decision on at least one of BIEL's "irons in the fire?" Getting them involved last time I think helped make the appeal meeting happen much faster than if they weren't involved. Can the pressure once again be increased? Thanks in advance.....
And by the looks of it, whoever is behind this has given out raises recently.
When I first read your post, I thought you were joking about that patch. Only one word came to my mind when I saw that list of companies at the end of your post with Carlyle Group, Essex Woodlands, Kaiser Permanente, Medtronic and St. Jude Medical. The word is "control." It would be nice if these companies were actually, truely interested in your health, but as we can all see, they are funding control. Also, when a real solution is presented from a company like Bioelectronics Corporation - that actually helps people, then you take years and years to get it through! Pathetic FDA!!!
The FDA manages to find time to 'pass' devices like this (no pun intended) but can't look at the clock for BIEL?!!!!!! The darker side of bioelectronics and the FDA. But of course they have time to track everybody. It looks like they solved the other 'passing' issue here:
MassPrivateI
Civil Rights Issues
Tuesday, August 7, 2012
FDA approved ingestible microchip tracking device.
The Food and Drug Administration has approved an ingestible digital senor that can track physical health with the assertion that patients are not taking their medication regularly and need a tracking device inside their body to assist them in their medical care. The mainstream medical industry has a term for this new type of spying: individualized medicine.
Proteus Digital Health (PDH) released the Ingestion Event Marker (IEM) which was first approved in Europe. George Savage, co-founder and chief medical officer at PDH claims that this ushers in a new era of digital medicine that “shifts the paradigm.”
The IEM, as small as a grain of sand, can be embedded in a pill, and ingested to monitor the patient and their bodily health. The device will collect measurements such as heart rate, body position and activity. The IEM sends a signal to your smartphone; which then transmits the data to your doctor. Actual real time data about your biological make-up can be uploaded wirelessly.
The US government, always looking for new ways to manipulate, has been pouring funds into implantable microchips that could monitor soldiers and the battlefield conditions effect on their bodies.
As pharmaceutical corporations turn their attention toward manufacturing bio-electronics , conventional medicine is being phased out. Treatment will consist of electrical signaling, monitoring of the body by implants that can transmit massive amounts of data, both physical and neurological, but also administer drugs without the necessity of the patient being involved. Basically, you will not need to swallow a pill; the pill will be administered to you by an implanted electronic device.
http://occupycorporatism.com/individualized-medicine-fda-approved-ingestible-microchip-tracking-device/
mapi at 7:11 AM
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http://massprivatei.blogspot.com/2012/08/fda-approved-ingestible-microchip.html?m=1
What does this recent testimonial mean? Question: Is Bioelectronics Corporation preparing to expand it's "workforce" and if so, what do they know right now for them to pursue this? Any thoughts? See link and the VP's comment provided below:
http://www.frederickworks.com/testimonials
"I highly recommend that businesses list their job openings with Frederick County Workforce Services, particularly companies that are also struggling financially. Recruitment advertising can be expensive, so the recruitment services available though FCWS are an absolute dream!"
Kelly Lorenz VP Operations, BioElectronics Corporation
Like many new "Technically Innovative" ideas, devices, plans, the Media jumped on it prematurely which helped BIEL considerably back then; prematurely meaning the media did not consider the backlash of Big Pharma or the never semingly ending constipation of the FDA decision making process: (Hint: Most drugs the FDA approves affect proper hydration of the body and in fact cause dehydration thereby creating further problems of the promotion of diseases that thrive on the lack of flow of water and fluids through the body). BTW: PEMF does not affect the hydration of the body negatively and will never contribute to the cause of promoting disease like many of the FDA approved drugs do....but I digress.....
I agree with you Chalu. That does seem to be the better way to go since BIEL needs a positive boost from FDA (Federal DELAY Administration) before spending more money; and that would do the trick to get the funds they need to do it right in Canada at least.
I like the news about the Spain order and if Andy wants to be in a trade show that's FIME with me. Canada news, I think would have been much better for shareholders right now.
Riding on what stallion70 said (no pun intended), I shall be so bold to make a prediction (guess) here on the BIEL board. Here goes: the date I am hoping for a HUGE EVENT is Tuesday, August 7th, 2012; which is one day before the year of waiting and one day shy of the 60 day response from FDA. (And could line up with Bone's Tuesday prediction from years ago and ImrichB's more recent summer prediction).
I'm with you on that stallion70. As mentioned before, August 8th will be the one year mark for proposed "any week now" approval for Actipatch & the 60 day mark for Allay appeal reversal! I had a sense that this is (sort of) what it must have felt like in the story of David (BIEL) and Goliath (Big Pharma & FDA & organized crime supporters) just before David took on the Giant and won! Oh, there was a lot of idle remarks made & disbelief, & probably a lot of statistics about how small the army was that was supposed to fight him, then to everyone's amazement - David (the underdog) won the victory against the giant!
Hey Simpsonly - Double play - all the way!
Thanks investordisciple.
Does anybody know someone or a way to even contact a group of MIT Electrical Engineers to swing by the board to assist and have a few laughs in the process? The debate for FDA approval could be enlightening!
I think someone should contact MIT to let them know what is taking place here; I doubt the FDA can oppose the logic and knowledge of one of MITs own alumni and therefore may get in on the 'game' somehow? FDA response is inevitable and will have many repercussions to any contrary decisions to this PEMF technology that seems to escape the understanding of some.
Remember that BIEL has a PhD from MIT to represent them. The opposition has 'what' to back them up? Or shall I say 'sqwhat' to back them up?
Also, it looks like that August 8th, 2012 the FDA will have taken (60) days to respond to the Allay appeal.
Does anybody know when the next update is?
Most here are Stage 1 bielievers, meaning we don't really care that much about current sales figures nor may we ever - as we are in this for the FDA play(s). It will be the Stage 2 bielievers you have to convince regarding sales, and since sales in the U.S. will be happening, sales will increase everywhere. Hint about Stage 1 and Stage 2 investors: It's old rocket science. FDA decisions are coming !!
Will the FDA or BIEL disclose the results of the meeting, or does the FDA notify the company and then it's up to BIEL only to disclose the final outcome; and isn't Actipatch up for an answer? Man, between the waiting and the BIEL board conversations.........maybe there should be three more follow-up meetings with the FDA to discuss how long it takes for this agency to produce a freaking decision.
You would probably have to disclose that you are wearing one - but since it's just a battery with a wire (according to some people) there should be no problem; if not then you will subject to a full cavity search, compliments of the TSA and their sister agency - the FDA, as some kind of poetic justice for them. (oh no he didn't . . .)
I wouldn't rule it out once a certain agency finally makes a decision on Actipatch.
It is known that many investors once interested in BIEL are in fact waiting for the so-called Non-event FDA approval. (Here is a NON-fact: This will be one of the first times in the history of a company where the pps does not react positively to FDA approval-due to it being a Non-Event.
No problem. (I remember 3M and ACE, but for some reason from those conversations, I was under the impression they were bought out by P&G).
I respect your opinion and understand that you would feel that way probably until an article was printed with a detailed story otherwise; and that's fine. But I believe that unless they plan on being bought out by P&G as was suggested by some longs here before, then I would not want to find out years later, that something surfaced about some behind the scenes dealings with P&G & Greenwood's washing each others hands - one part of their so-called plan could be for P&G to simply have Greenwood do nothing - as they have so far. How can you prove that? That's why it's a conflict. Either start to help BIEL reach its goals or get out! Well, since accomplishing NOT a flapping thing for several months is their specialty, we can't prove anything right now, nor would I care to, but based on the total lack of effort so far displayed by them - and them having a client that is a potential hostile client to 'your' business, to me it's a no brainer decision to shed the dead wood. (It's easy to frustrate the little startups on the block when you have far reaching resources).
Got it! "When "I" look to invest in any company, I start with the product/service (s) they are selling/offering, then look at their financials." Got it. Now that you have clarified how dismal BIEL's future is - I guess there is No Point rehashing old news? Moving forward, instead of being stuck in a rut, what's the game plan now?
Good one; about nine months later Greenwood at least had their Web Master update their site. What motivates Greenwood? Apparently not much. One question about the website; Isn't choosing a distributor who deals with P&G a conflict of interest - considering - correct me if I am wrong - it was brought to light that P&G owns ACE bandage, which BIEL is a potential threat?? If true, No wonder Greenwood is dragging it's A.
Thank you Investordiciple! Great article about the FDA! Light is being shed on the truth behind the scenes. How diabolical to monitor employees that are concerned for the well being of people - in this case specifically - women. It looks like the FDA is run by a bunch of hoodlums belonging to the "he-man woman haters club" because Allay, made specifically for women and having no reported side affects is another example of this farce at the FDA. Finally, the so-called conspiracy theorists don't look to be so strange now after all.....
I can think of at least one other thing not mentioned that did not take a hit yet .... and that's why they are still in business.
I have tried the Actipatch and it worked great, but more importantly it did not burn me like SalonPas patches could of; I could buy 120 SalonPas patches for next to nothing - but really, who needs more pain when you are trying to get rid of the pain you already have; and that's what Actipatch does - it removes pain without any side affects, which PEMF technology has done for decades.
The chart is looking pretty good Danzo; and great news will send this way higher! We must be getting close to a response from the FDA. As far as marketing is concerned, last week I saw a display of Slushy Magic in CVS and I thought that the display would fit BIEL products very nicely. I would like to know how they got the money to do this display and why BIEL (through Greenwood) hasn't done this in Canada? There were multiple shelves for all of BIEL products and plenty of room for initial sales opportunity.
Thanks. GLTY also.
Let's go FDA and push out any doubt!!
FACT: Salonpas, BIELS's competitor, can cause burns, FACT: but you can buy them cheaper than Actipatch - but Actipatch won't burn you!
(If this gets deleted, do please explain so I can understand why we are not allowed to mention competitors like J&J, P&G, and SalonPas - thank you).