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Since I was not invested in BIEL when it rose to 12 cents, I am hungry for information comparing now to then and potential pps in preparation of an exit strategy.
I understand that, at the time, the CEO was perhaps saying too much to too many about the FDA process and potential approvals being soon and so on (i.e. inappropriate blah, blah syndrome), along with a PR man extolling the virtues of BIEL.
Up it went from around .004 to 12 cents over a period of a few months. Nothing from the FDA, no rejection, no appeal, no Senator Barbara Mikulski, no Inspector General, no bio-physicist, no meeting with 20 plus FDA people, no message from Paul stating BIEL had adequately addressed the new FDA issue of concern, all conditions we see now.
Here we are a few years and a lot of angst among shareholders later and waiting for FDA approval on ALLAY, which I don't think was prominent in 'approval soon' mode a few years ago and ActiPatch, which was. Casper supplied sound mathematics illustrating 12 cents then being same as 7.5 cents now, which is great for those in at under 1 But, my curiosity is specifically related to the ever elusive investor sentiments and pps now if FDA approval on ALLAY and ActiPatch evolve in the next 3 to 6 months. It would seem that, with either of those approvals occuring, BIEL will then be better positioned to do traditional retail drugstore deals with the majors in Canada and the US, notwithstanding that I think they should do any deal they can in Canada right now. Thanks to responders.
Hey sausage - good viewpoint, but I did remember the meeting last August, the CEO's "soon" comment and the later question answered by fax. But, something is still fishy as I think a "subsequent issue" has been authored to save face. If BIEL did not answer the December question adequately, FDA would have bounced it and asked for further clarification. I just spoke to someone who has led submission teams with the FDA and they can go back and forth a hundred times. My jury is still out, however, regardless, this sounds pretty good and time will indeed tell. Cheers
Paul's comment.....
"The reason we expect an answer from the FDA soon is predicated on the discussions at the meeting. The reason we did not get resolution at the prior meeting is that the FDA came up with a subsequent issue. We think, now that we understand their issue, and we have provided an adequate explanation."
What and when was the "prior meeting" could be critical. Could it be that this was the second meeting with FDA since the rejection on ALLAY? Or, does it mean there have indeed been 2 meetings, but one before the rejection and this last one, meaning perhaps that the rejection was because FDA came up with a subsequent issue after the first meeting which was after the rejection.
If one looks very carefully, FDA and BIEL had a meeting. FDA came up with a "subsequent issue" and then rejected ALLAY? Makes no sense. If they had come up with a subsequent issue, FDA would have asked for more info/answers before rejecting. I say there was the rejection, then there have been 2 meetings since the rejection....BIEL did not get resolution at the prior meeting AFTER the rejection and FDA asked for this last meeting to get clarification for that subsequent issue, which they did on Friday, and that is why BIEL now expects a positive answer "soon" - because the answers to the "subsequent issue have been provided to the FDA's satisfaction.
And that may be why the invention of the difference in tissue to separate ALLAY and ActiPatch. C'mon, the FDA has a plethora of data now on both products. This also seems to me to be the very necessary diplomatic camouflage for,
"Let's see, how do we find a way for everyone, FDA & BIEL alike, to save face? Aha make it a double face saver - subsequent issue and tissue difference - wonderful, that should do it."
Never forget fellow investors, we are dealing with humans and when humans err we all need a way to save face rather than having bashers pounding people into the ground in a demeaning fashion and detroying their dignity. I like it! The shorts may not, but I do!
Add to your wise post, based on your personal experience fuente, that if, and I say it carefully, if, the bio-physicist representing BIEL's science has the professional credentials AND left data representing hard science in support of BIEL, then this dog will hunt and the FDA will not be pioneering. I like it.
Michael - there are perhaps only three reasons why the FDA and BIEL could not possibly have danced to the same tune as they 'may' be today:
1 - BIEL's management has not done this before and all that means, compared to a J&J or a Pfizer with huge scientific horsepower and communication and documentation skills;
2 - Money and all that means; and
3 - BIEL's product line had had FDA stumped as to classification for some time.
The combination of these reasons is not grounds for going postal. Please relax, otherwise some may infer you are only trying to generate negativity because you are short a ton of shares at .0020. I don't believe that is the case, I think you are simply venting your frustrations at the passage of time, which we will never get back. So? Let's move forward.
I have read all your posts with interest and am trying to find the underlying reasons why things are presented so vehemently and in such a black and white fashion? Is it at all possible that FDA, as part of its service requirements to its customers, the applicants, and the US public, simply wants to get it right and has processes allowing it to re-evaluate? That is not DD, it is process of determining what is best. Suggest you relax and enjoy the BIEL ride.
your horse is pretty high and demanding. It may not be slap you in the face obvious but why would FDA agree to schedule a second meeting in July on ActiPatch if there had not bee some stimuli at this meeting?
Think your numbers may be light fuente - BIEL went from .0020 to north of .005 on a denial on ALLAY!
Approval on ALLAY followed by approval on ActiPatch will take it beyond your predications of .01 on ALLAY I think.
My take on the July meeting for ActiPatch is that FDA folks, who are relatively new to medical devices AND understaffed AND with little funding in the area may have asked if the same rationale as given by the good bio-physicist on ALLAY would be applicable to ActiPatch. Any scientist of merit would have asked for the leeway to re-examine the data and indication and report his findings to the FDA. It also tells me that FDA may have accepted, under advisement, the technical explanation on ALLAY. This all makes sense to me. They all want to get it right on both products. Anyone find any holes in my theory?
Is this legit? It's bio-physicist.
Regardless, a great meeting by the sound of things.
I'mRich could have been right on at 20 cents or even light?
Hey firedancer - I suggest respectfully that if you re-read back through ImRich's posts 22428 - 22427 and then 22424, he makes it pretty clear. I only wish he were in the meeting with the FDA to simplify things somewhat. He states that heat has been mentioned for a long time and that the FDA simply classified ALLAY incorrectly.
My take is that the verbiage about BIEL product not creating heat, or a user not noticing heat is simply addressing the questions or concerns - "Will it get hot?" Or, "Will it produce a lot of heat or perhaps burn me?" Or, "Should I, as a user be concerned about leaving it on and falling asleep?" No doubt in my mind, there are two discussions addressing the word "heat", but it seems that one dialogue is scientific or technical, the other is consumer safety related to ALLAY (sorry) consumer concerns about noticeable or harmful, burning heat. One is technical data, the other sales & marketing related. Perhaps the information was erroneously co-mingled? I believe the facts are that BIEL products can be left on for days without harmful side-effects caused by heat AND that the product will raise local tissue temperature by one degree C. Hope my thoughts help.
Hey SuperStarDozen - if BIEL goes from sub-penny to $ .30 as the other one you refer to, that's not all bad and if it's this summer, then I'mRich is my hero.....
But, my take is if BIEL gets the FDA approvals it apparently should on ALLAY and ActiPatch and makes deals with 6 large drugstore chains here in the US, then it seems to me it could hold at $ .30, stabilize, and grow from there in a sane fashion. Am I reaching here?
Thanks Chalu - sorry for delay in responding to your feedback - been in the air today - hopefully the trending is similar in eastern Canada. Everything has a beginning. Can you imagine the east coast, Florida, the mid-west and California here?
Yessssss - thank you I'm Rich - you've made my evening.
Can you help with my curiosity about Canada?
Thanks
Hey Super - could it be that the Canadian retail drugstores have simply declined? Or that the retailers up there have tired of hearing about BIEL and are actually waiting for the waters to settle somewhat with the FDA?
I am looking at one of the ActiPatch packages my buddy in Toronto sent me a couple of years ago for my badly sprained ankle. It states, "Health Canada Medical Device License No. 73574"
Then in another section it states, "Manufactured by / Fabrique par: BioElectronics Corporation www.BioElectronicsCorp.com"
Then, under that, it states, "Distributed by / Distribue par: Locin Industries Ltd. #200 - 18 Gostick Place, North Vancouver, BC V7M 3G3 Canada www.locin.com." Great looking package, by the way.
I have only been around this board a few months - did Locin Industries approach Canadian drugstore chains? I think that would be a safe assumption. What was the response? ActiPatch was obviously licensed as an approved medical device with Health Canada at the time, why would then be any different from now? What don't we know about that? Can anyone help?
I'm with you Rich - there is a smell in the air. Paul and Robert are going at each other and beyond a number of lines of dignified discussion and debate.
To Paul and Robert, the accusations you are making are are flying in the face of logic and litigation is just around the corner. There is lots of libel here to keep lawyers busy for a while. Meanwhile, no one really cares much about he said/she said issues, but we do care about:
- How BIEL is doing opposite the FDA;
- How is the FDA going to retract and reverse the decision statements, that BIEL, I assume its legal counsel, and posters here say are erroneous and approve ALLAY, while saving face at the same time?;
- How is the ActiPatch application going at FDA?; and
- What progress, if any, has been made with making a deal with a retail chain of pharmacies in Canada, Shoppers Drug Mart, Katz Group (Rexall, IDA etc) and the Jean Coutu chain and all the other countries where BIEL's product line has achieved approval?
Just did a little reading. Shoppers Drug Mart, Pharmacie Jean Coutu and the Katz Group operate approx. 3,500 drugstores in Canada and the US, doing approx. $18Billion(CAD$). By comparison, Walgreens operates 8,300 drugstores and does $72Billion(US$). The US is generally considered to be 10 times Canada in many categories. Therefor, if I'm the CEO of BIEL, is Canada not my number one priority and focus and wouldn't I love to do a deal with those 3 drugstore chains? All of them? While my legal counsel, Senator Barbara Mikulski and the Inspector General figure a way for the FDA to save face? Make a deal BIEL.
Hey Super - I agree with Bishy and bonchien (good dog) but not ProMaster on this one - In Canada it will have a lot of merit that Health Canada has approved ActiPatch and ALLAY for OTC sales in that country - IMO FDA approval means little. The Canadian door is open, sell it there and now!
So, I continue to scream (in lower case) "make the deal BIEL". I would be astounded if the CEO of BIEL does not agree with me wholeheartedly. I will go so far as to say if he does not agree, he should be replaced yesterday. I would bventure to say that J&J or P&G would have it in Canadian retail pharmacies by now. They would throw the dough and the manpower behing the product line and make it happen because they are powerful machines. I am mindful of part of Mr. Whelan's radio interview when he said "we're not sharing". Only a fool doesn't change his mind and I would rather have a smaller piece of a bigger pie, thank you.
For BIEL to make a deal in Canada will continue to embarrass us in the US - meanwhile fight the good fight at FDA - they know by now that they made an error, if what the company is telling us the truth in the President's letter to shareholders. There are numerous astute posters here who support that the FDA made a colossal error in its assessment of the technical aspects of ALLAY - they may well be trying to figure out as to how to save face - an important part of the regulatory process.
Make a retail pharma deal BIEL - even if you have to put 100,000 units into Canadian pharmacies on consignment - do something!
Good point re Canada Bishy...I presume it takes many months to negotiate and plan a large retail launch like Shoppers Drug Mart in Canada. I have suggested here that the company would be well advised to be negotiating with the Katz Group up in Canada simultaneously with a period of exclusivity to the winner - those firms are arch rivals. And, according to my buddy in Toronto, apparently they both have a huge rival in Quebec named Jean Coutu.
Let's go BIEL - you will never get this time or running and expiring patent time back- make a deal. And what do we hear from or about Greenwood? I've not heard a thing. Has anyone making calls to Canadian stores and pharmacists, "yes, w've heard about ActiPatch and ALLAY going into the pipeline for launch in such and such a month"? Have you had any such feedback Casper? I would simply like to know that the company and its Agent are in discussions with Canadian pharmacy chains.
Nothing from me Super but complete agreement. These forums should be full of dignity and without ulterior motives of negativity. There is one poster who I am convinced is a disgruntled former employee with an axe to grind. I have submitted respectfully that this is not the forum to prolong his grievances and bitterness, to no avail. I am not his keeper, so now I mosly ignore, at the suggestion of other posters.
Hey Jimzin - gotcha - "stockdarockk", enough said. Saw some earlier messages which gave a clear glimpse of the style. Thank you.
Jimzin & Super - who is poster in question - must have missed the message osted before it was deleted - been in and out all day.
Thanks
Couldn't agree more with you Rich - makes no sense.
I'm not a fanatic, but it is nice to see the US high in the rankings for so many things in the global community. First is great, second or third are okay too, but to not even be in the game?
An American product line, by an American company, patented in our USPTO, RecoveryRx long approved by our FDA, ActiPatch and ALLAY now approved in dozens of countries globally, where, with strong Distributors and some marketing spend, hundreds of millions of people can benefit and here at home our lights are out?
The ultimate insult would be if numerous countries equipped their male & female athletes with BIEL products for the Olympics this summer and they have a legal edge we don't. Then our Olympians could beg, borrow or steal ActiPatch and ALLAY from their opponents! This potential embarrassment alone should be incentive enough to the politicians and bureaucrats to immediately remedy this.
Hi Casper - found this store locator site on the Walmart Canada website
http://www.walmart.ca/canada-estore/stores/storefindercontainer.jsp?lang=en
Then, after entering "Toronto", which is Canada's largest city, the addresses and phone numbers of the stores in that area are found.......
http://www.walmart.ca/canada-estore/stores/storefindercontainer.jsp?_DARGS=/canada-estore/stores/fragments/storefinderpage.jsp
People owe you a debt of gratitude for your diligent efforts, the phone calls and E-mails - I am one of them....thank you.
very astute and positive contribution J - Thank you.
I'm sorry Doodles - your reference to apples and oranges somehow being analagous to your and my opinions on pacemakes and the lungs and you saying BIEL is a scam lost me completely. Am I the only one confused by your post?
BIEL is not just a stupid wire and battery as you alluded. To go to your lung analogy being passive versus my pacemaker wire and battery combining to stimulate the regulation of heart beat, may I respectfully suggest that, if I follow your logic, both the respirator and defibrillator are just more crappy devices, also patented, manufactured and sold by charlatans to stabilize the passive act of breathing and to deal with a heart that has stopped? Seems BIEL is in good company as all, including BIEL have FDA approval. None of the BIEL devices is a back-from-the-dead lifesaver, but they are safer than drugs, the efficacy is terrific and as intended, there has never been one negative side effect and there are hundreds, if not thousands, of studies and trials describing the positive effects of PEMF. Lastly, FDA has approved BIEL's RecoveryRx. So, I guess everyone, including FDA, is confused but you. Yesssss.
Hey Fuj - great post. I am intrigued by the "things" you mention that are in place now for BIEL that Doodles is not aware of. If you feel it is better not to comment, I will respect that. Those "things" that are in place must have come about since Doddles left the employ of the company. If they are good, no wonder she is so disgruntled, I would be too.
You are right again Doodles. My hope is they pump BIEL to 50 cents, then short it like crazy the day before the FDA gives OTC approval to ALLAY and ActiPatch and after it's dropped to 40 cents. Then, it pops to a dollar and we buy a couple of defunct brokerage Boiler Rooms for a coffee! I know it's not logical, but keep in mind, I am responding to another post. Go Doodles, go BIEL.
Hey Gman - what really ticks me off is that a small/tiny American company created an essentially American product, worked like crazy with our American USPTO to extend patent protection, which is ticking away every day, by the way, then applied to our FDA for OTC classification for numerous innovative PEMF devices that have NEVER, EVER shown any negative side-effects whatsoever and already have one product, RecoveryRx, which is Rx approved, by that very same FDA, for use where? Over and around the human, not dog or rat, but the human eye, post-op, that would be close to the BRAIN, and they, the FDA, apparently can't get the technicals right to approve ALLAY designed for the relief of menstrual cramping and pain in womankind? Have I articulated this absurdity correctly?
And to make matters worse, according to what my my old classmate up in Toronto who sent me the ActiPatches for my sprained ankle says, "Canada, our friendly little neighbor to the north with about 11%, 11% of our population, who helps us out in times of crisis, Iran Embassy 1980's, 9/11, most every war we have been in, with all the fresh water, oil, better manners and strict gun rules - he said, "they (the FDA) what?, are you kidding me?" about the FDA debacle. And Canada got ActiPatch and ALLAY right?
I'm embarrassed because I can't throw anything back at him other than, they're working on it. Lead country in the world, 315 million people, pretty good standard of living compared to most other countries, yes, we have some stuff to work on, and we can't get harmless PEMF right? Embarrassing that's what it is and I hope Senator Mikulski tells 'em that.
Yes, I have a conflict, I am a shareholder, but is this what we do to little American companies who want a classification on a device using a system that can not generate a negative side-effect? Embarrassing. If BIEL made a mess of this, or the FDA, let's find out and then I, and every other shareholder deserves an official apology. I'm not mad enough to demand financial compensation, but I'm close!
Ha! I don't mind the company selling shares Rich, as long as they put the funds toward getting BIEL trading in a real forum where the public can learn of the story - OTC BB
Doodles, you are totally correct - same as another really stupid wire, the same as BIEL, and one small battery, same as BIEL, can't keep people alive - no way, shape or form - Pacemaker? And about a thousand other devices! Everyone thought the inventors of that stupid device and Dr. Christian Barnard were really stupid. Imagine being so stupid as to believe in a Pacemaker!
Anyone know a bruised up pro ball player or hockey player who might wear an ActiPatch in a televised game or 6?
Even better, a doctor prescribed RecoveryRX for an eye injury or a nose injury - KB wore an unreal mask for the schnozz - a little protection, but no pain control or healing stimulation......
Just a final thought or two on my previous post - I am very heartened by the fact that Senator Mikulski is carrying the BIEL torch. Senators must not, and should never be, put in an embarrassing position and avoid such like the plague. BIEL would have had to carefully take her and her staff through how the FDA erred, in simple terms. They would need to have been 110% convinced the error was made by FDA and they were on the right track, otherwise they would have simply smiled and wished BIEL well and stayed out of the fray. Seen it happen that way a few times. But when a Senator is engaged in a just cause, they carry huge weight.
There is a great pictur e of Senator Mikulski on Google giving a speech-it looks as if she is yelling. Can you imagine a shy person sitting in a small cubicle at FDA, looking at that picture and the nightmares later knowing they had risked the wrath of the Senator by screwing up on the BIEL application for ALLAY? The next picture in the cartoon would show that person's lower legs and feet as they are diving into a filing cabinet! Other pictures on Google depict the Senator in a very gracious, dignified light, as a warm and engaging lady, but that one depicts her as cutting someone a new one Mister and don't you f-----g forget it, are we clear?!!!!!......... :)
It will be very interesting to see what transpires on the pending ActiPatch application. My take is that FDA will be very careful to review it's previous work and decision on ALLAY and ensure it does not compound the alleged errors onto ActiPatch as well. This may cause a delay in any ActiPatch ruling while they make sure they get it right.
The other potential outcomes are interesting too. Given that the Inspector General for Health is 'on the ALLAY case', as it were, on one side and BIEL and its legal counsel and Senator Mikulski, a highly accomplished health and women's advocate for a few decades are all on it too,on the other side, who would want to stumble next at FDA?
The Director at FDA would have to shoulder all the responsibility / accountability if the technical error on ALLAY alleged by BIEL is repeated and compounded on her watch. What does she say to the IG then? I could give another 50 'what ifs', but it is an interesting political and tactical situation, in my view.
Heads could roll at one extreme, if BIEL is technically correct and FDA missed the boat a second time on ActiPatch in in its analysis, or, FDA could issue a positive decision on ActiPatch and an immediate ALLAY reversal at the other extreme - sort of,"based upon our subsequent further review of the ActiPatch application and accompanying data following the earlier decision on ALLAY, we have conducted a thorough review and comparison of both the ALLAY and ActiPatch applications and our previous decision relating to ALLAY and find that we have determined that there were minor discrepancies found existent between the two applications which led us to a further clarification process with BioElectronics, the Applicant and the implementation of a corrective procedure to the previous ALLAY decision, etc., etc."
That would be very cool face-saving for the FDA, which may be what is needed. And there are lots of diplomatic possibilities in between. In any event, if such were to occur, that would be the time the company simply says "thank you" and moves on, thereby allowing the necessary face-saving. No question in my mind, this could be a diplomacy play.
If anyone believes for one second that FDA has not already looked carefully into the allegations that they screwed up and determined that an error was or was not made by FDA, then they are naive. If an error was indeed made as alleged by BIEL, then some folks at FDA have already huddled and asked questions such as, "what are we going to say?" or, "how can we correct this?". I hope this is the case, rather than stubbornly digging their heels in to defend to the death a wrongful decision. FDA has made erros before and probably knows how to correct them. I just hope BIEL's protests are well founded in the technicals and science of it all, which I know nothing about.
Thanks hotdog - there is no question in my mind that paying the dough to move BIEL to the OTC BB will increase the number of shareholders from 201 to 200,001 and beyond.
I am advised that trading on the Pinks is like being in the middle of the Sahara without water. Or, better yet, Death Valley and I can see the lights of Vegas to the east. Mortgage the farm Mr. Whelan and get your company trading where it ought to be. Even potential big pharma buyers will look at you and wonder about your judgment, being on the Pinks. Any sale transaction price will be based on pps! It's only about multiples Mr. Whelan, unless you would be happy with chump change.
It appears to me you need some plain talk - you just got it. I am a big fan of your product line and where BIEL could potentially go, but not of where your company trades.
Phoenixdove & Dubb10 - Thanks a lot, but I knew that about E-Trade and numerous other firms, have a couple friends using them exclusively. I do some e-mini trades on the S&P Index and other trading and I prefer to deal with the firm I've dealt with for many years. I rely on them for technicals and their researchers. Also been involved corporately with the senior people on a couple of underwritings. It's a personal thing, even though I pay a premium, I'm happy and I suspect they cut me a deal because of the relationship - they know I can go elsewhere and that I would not. The extra fees I paid to clear BIEL were mostly out-of-pocket for them. I also experienced very little harm during the crash because of them. Just good luck, rather than good planning, but there you are.
To recap - there's the answer from Phoenixdove - E-Trade does not charge extra to have BIEL trades settled/cleared.
Yes sir/m'am - $200 per day of trading whether you buy 100,000 or 20 million shares - $200
I also wrote to the company asking why they would not simply pay the money to move this little company to the NASDAQ OTC BB. I have felt that all the talk about audits and accounting firms going broke was just double-speak for cheap.
My brokers told me it may be a case of amateurs looking like amateurs instead of being concerned about presenting the highest possible professional image befitting a company applying for FDA approvals instead of someone operating out of their garage.
The major stockholders of the company, I assume the Whelan's, should mortgage the farm and move the company to a legit trading platform. My gut tells me that the stock is at a buck on the OTC Bulletin Board before approvals, but what do I know. I've only been a major stockholder in two so far. Wish I owned BIEL, I would pop 3 to 5 mill into this baby and we'd be on the way. Top legal firm, top FDA firm like FDARegs.com and Allan Green, who I mentioned a few days ago, and away we go like pros. This is not rocket science, it's PEMF! Been around a long time.
Cost me an extra $200 for any and all transactions in a day to have them cleared and settled. Brokers try to dissuade clients from trading in such stocks because it is more work (labor/cost) for them. Tell them to stop whining and do it. You're a client. Then tell them you are buying a special, custom made broker's, banker's, FDA AssiPatch because they are a pain there! :)
Just an observation, but who buys or sells 5,000 shares of BIEL? That's $24.00. I also saw one trade of 1,000 shares - $4.80???
Is a market-maker deliberately trying to embarrass himself?
Hey Fuente - thanks for the feedback - the info below is from Seanator Mikulski's website - she may very well be the perfect advocate for women and BIEL that is much needed to get ALLAY and ActiPatch on the OTC shelves. She is all about health, health, health and women's health at the bottom. This lady has an amazing track record - wow
QUOTE“I will never stop fighting for health care you can count on – at any age.“ -- Senator Barbara A. Mikulski
Saving and strengthening Medicare
•Closing the prescription drug donut hole
•Ensuring seniors won’t have to pay more for recommended preventative care
•Incentivizing higher quality value care, not volume care<
•Finding solutions to extend Medicare’s solvency, so it doesn’t go broke in 2017
Ending punitive practices of insurance companies
•Making sure insurance companies can’t deny coverage to anyone because of pre-existing conditions
•Making sure your coverage can’t be canceled because of an unexpected health condition or mistake on your application
•Requiring insurers to publicly disclose and justify outrageous premium increases
•Requiring insurers to spend at least 80 percent of premiums on direct health care services
•Strengthening consumer protections to eliminate lifetime and annual caps
•Requiring preventative care with no co-pay and no deductibles
•Allowing young adults to stay on their parents’ insurance plan until age 26
Championing health care quality, prevention and integrative health to save lives and save money
•Using best practices to reduce medical errors
•Encouraging discharge planning to reduce hospital readmissions
•Simplifying administrative procedures and facilitating enrollment into health and human services programs to save billions per year and reduce the hassle factor of health practitioners
•Coordinating care and creating community health teams to save money and reduce chronic conditions
Fighting for universal access to health care
•Expanding Medicaid to an additional 16 million Americans
•Expanding coverage to 32 million Americans who were uninsured
•Establishing health exchanges that will make health insurance more affordable and easier to purchase for small business and individuals
•Providing tax credits to small businesses to make health care more affordable for them
•Providing subsidies to employers who provide health insurance to early retirees not yet eligible for Medicare
A lifetime commitment to women’s health
•Helped create the National Institutes of Health Office of Women’s Health to study women’s needs and health issues
•Created the Mammogram Quality Standards Act and continues to fight for strong standards and yearly facility inspections
•Ending gender discrimination by insurance companies, so being a woman is not considered a pre-existing condition
•Requiring screening and preventative care -- including annual mammograms for women over 40 -- for no co-pay and no-deductible
•Fighting to make maternity services part of essential benefits package
•Allowing women to see their OB/GYN without a referral
I find it incredibly fascinating that an FDA Commissioner would forward an appeal up to the IG of Health & Human Services. Does the Commissioner automatically hand it up a notch? Or, review it first to see if an error has actually been made? Does anyone ask the decider if it is possible they missed something or misunderstood something, as can happen?
Why not have the Commissioner read the Applicant's correspondence, assess the decision and data, perhaps have a meeting where both parties can actually sit down and discuss the matter and explain technical positions and clean up the problem if an error has indeed been made, in perhaps a couple of weeks? There's a concept!
Amazing how one can visit DC and drop in unannounced to one of their Senator's offices for a quick meet & greet and a souvenir of the visit, as I have done, yet, the regulatory processes can take years and years, with only the occasional letter. Because there is no accountability at the whim of the voter for the bureaucracy and the Senators know who put them there-every four years and where those campaign checks come from! Campaign contributions ar very simple - if you take a check from everyone, you don't owe anyone anything, but you do a better job and you don't jerk folks around.
Hey Pro - you seem well versed on PEMF - would you please define "skyrocket"? What is your feel....notwithstanding there are more shares than in 2009, different economy, different Wall Street, combined with different views now on ecology, drugs, chemicals, etc.
Thanks very much