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The FDA has already approved BIEL's product for prescription use under the ActiBand name.
"This letter will allow you to begin marketing your device as described in your Section 5 10(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device to
proceed to the market"
http://google2.fda.gov/search?q=cache:0dCNdy3azQcJ:www.accessdata.fda.gov/cdrh_docs/pdf2/k022404.pdf+actiband&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&ie=UTF-8&access=p&oe=UTF-8
The FDA equivalent in dozens of other countries have approved BIEL's products for OTC sale.
I hear you Simpson and agree. If the FDA were a business they would be out of business because they don't meet their commitments.
I try and focus on Dr. Kotak's words when he said that BIEL will be successful with or without the FDA. I feel that Dr. Kotak is the force behind our success in the UK. AW needs to stay behind the curtain and let the good Doctor who is also a Lawyer become the public face of BIEL.
Unfortunately super it seems that the FDA is oblivious to pebbles.
The only things that can rattle their ivory tower are the President, Congressional Hearings, and public demonstrations.
After former FDA Chief Margaret Hamburg approved Zohydro, a strong new opioid drug, going against her advisory board, the "Fed Up" organization held protest marches. Hamburg resigned several months later.
http://abcnews.go.com/blogs/politics/2014/09/at-white-house-prescription-drug-protesters-call-for-new-fda-chief/
In this case it is more than an opinion Lizanne. A Jihad was declared many years ago over an employment dispute. Our Jihadist will fight on as long as there is breath in his body.
The comparison to Coronado is fine by me. It is one of the nicest communities in my area. Homes go for an average of 1.3 mil. The Hotel Del Coronado has been a top Southern California destination for 125 years. The Naval Air Station at Coronado is home to many of our nations best military men and women.
UK, this could all be just MMs balancing their accounts but the general rules of trading are as follows.
If the transaction occurs closer to the Ask price it is considered a Buy, closer to the Bid price it is considered a Sell. .00068 is 2 points away from the Ask, and 8 points away from the Bid therefor it is acknowledged that the buyer wanted the 9 million shares more than the seller wanted to sell them and the buyer capitulated and moved close enough to the Ask to trigger as deal.
We have no control over the FDA and their bureaucratic maze of a system for reclassification but we do know that in a little over two weeks Q2 data will be released. Q2 sales is the current object of my interests and why I have added 10% to my 8 digit position.
With the bid at .0006 and the ask at .0007 today's T-Trade of 9.389 million shares at the transaction price of .00068 was a Buy.
22 16:04:36 0.00068 9,389,417 form t nasd 0.0006 0.0007 9,389,417
BuyVol .................SellVol
14,622,917 ...........10,928,965
http://ih.advfn.com/stock-market/USOTC/bioelectronics-corp-pc-BIEL/trades?trade_set=recent
dd, I don't quite see your logic here. There were ZERO transactions at .0006 today. There was a 3 million share Form-T transaction reported after hours at a price of .00068 . If you say that you were rounding, why did you go down 8 points rather than up 2? Please explain your reasoning to the board.
22 16:06:54 0.00068 3,000,000 form t nasd 0.0006 0.0008 3,000,000
All great points seven. There is overwhelming evidence that BIEL is gaining momentum. To expand on just one of your points, the Boots relationship. Boots, now the Walgreen Boots Alliance, the first major retailer to stock ActiPatch on it's shelves. Boots rolled out the ActiPatch to 310 stores in 12/2013. After seeing the sales numbers Boots added an additional 275 stores to their ActiPatch program in 4/2015. 585 stores stocking the Actipatch may sound great, and it is. The even greater part is that Boots has a total of 2500 stores in the UK. There is much more growth to come in the UK market.
Boots is not just a UK business. Check out the total scope of their stores:
Number of retail stores by country*
United Kingdom 2,511
Mexico 1,021
Chile 447
Thailand 254
Norway 160
Republic of Ireland 80
The Netherlands 67
Lithuania 25
Total 4,565
The acquisition of Boots by Walgreens adds another 8000 stores to Walgreens Boots Alliance.
So dd, the hundreds of positive posts from ActiPatch users are all plants by the company and the handful of negative post are honest feedback? Is that your theory?
"You-can-see the manipulation in-the 1000share painted lifts"
What stock are you talking about??
Today's score for BIEL:
Buys = 3,994,552 all at.0008
Sells = 223,015 20k at .00071 , 203k at .0007
After close T-Trade Report = 1,553,700 at .00078 classified as a Buy
96% of the action today was BUYING!!
Wow!! 11am and already 10 posts in the bag. dd is in Blitzkrieg mode. Must be good news on the way.
Thanks for alerting the board to the mtoronto post yankee. mtoronto now has a follow up Yahoo post titled 510k:
"I have mentioned this before, a 510K can be submitted prior to the final order with special circumstances asking for OTC clearance. Coupled with the fact that a publication is due in the coming days, expect great news.
Trust this helps."
http://finance.yahoo.com/mb/BIEL/#mbt=510K&mbl=http%253A%2F%2Ffinance.yahoo.com%2Fmbview%2Fthreadview%2F%253B_ylt%253DAvXR8tpMy5gUMz992uXYgBHeAohG%253B_ylu%253DX3oDMTB2cGljN2lsBHBvcwMxNQRzZWMDTWVkaWFNc2dCb2FyZHNYSFJVbHQ-%253B_ylg%253DX3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-%253B_ylv%253D3%253F%2526bn%253Dd339e701-da16-34c3-9488-7eda96ab4804%2526tid%253D1437424600153-9aa7dc19-d258-4b11-ba28-6892418161de%2526tls%253Dla%25252Cd%25252C0%25252C3&mbtc=mb-tab-topic
If you are going to start trashing Chinese manufactured products you will have to first hand over your iPhone and any other Apple product you own, HP computer/printer, Samsung computer/printer/smart phone, Sony camera/laptop/camcorder. And thousands of other products from most of the world's major manufacturers. Welcome to the Global Economy.
https://www.facebook.com/lloydspharmacy/posts/10152588486382609
Sharon Dalrymple?LloydsPharmacy
July 14 at 11:24am ·
Please start stocking acti-patch I can't live without it as a Eds Ht patient and it would help if I could it locally, would make a huge difference, thank you
??
Like Comment Share
LloydsPharmacy Hi Sharon
I've asked our Buying Team about this and will let you know as soon as I've heard something.
Kind regards
Ian
Like · Reply · 1 · July 16 at 2:12am
https://www.facebook.com/lloydspharmacy/posts/10152590159022609
Susan Jackson?LloydsPharmacy
July 15 at 10:06am ·
Please lloyds can you stock actipatch
Like Comment Share
LloydsPharmacy Hi Susan
I've mentioned this to our Buying Team and will let you know as soon as I've heard anything.
Kind regards
Ian
Like · Reply · 1 · July 16 at 2:13am
Over 90 Testimonials on the UK ActiPatch site, http://www.tryactipatch.co.uk/pages/testimonials . It feels great to be a part of something that is changing so many lives.
“I have had Raynaud's disease for a number of years, the pain on return of blood flow after an attack is horrendous. Painkillers are unsafe and after a severe reaction to prescribed medication which could have been fatal, I decided to try alternative sources. After sourcing the direct central pain which seemed to be around my left shoulder and neck, I placed the wire on the area surface. I did not expect the ActiPatch to work at all but purchased the product as an alternative to medication, which any pain sufferer will tell you, do not work anyway merely numb pain. The difference was remarkable the scientific mechanics of this product are in my opinion better than any medication I have been on in over 20 years. The ActiPatch actually works you don't have to take my word for it, but you will not need another tablet ever again!”
- Nicci Harrison, United Kingdom
"I fractured two vertebrae in my back. I bought ActiPatch at Boots and put it on, within an hour the pain was much reduced. I have not taken any pain medication since I put the ActiPatch on."
- Deb Evans, Holyhead United Kingdom
"I got a sample ActiPatch and gave it to my mum, as she has terrible hip pain. Mum loved it, she said she felt great with it on, what a difference it made to her. Thank you for your little miracle worker."
- Catherine Milliken, United Kingdom
“I have suffered back pain for 30 years, every day, constant agonising back pain, as well as pain everywhere else. I used the ActiPatch 7 day trial on my back and within 24 hours, the pain was gone! I have tried medications, injections, needles, TENS etc, nothing helped until I found ActiPatch. It’s amazing.”
– Su Eriksson, United Kingdom
"I'm waiting for a hip replacement, and in the past 9 months I've had to have morphine patches, oral morphine - you name it I've had it. I've spent four months in bed because I couldn't walk or move. Today I tried ActiPatch...and maybe I can go out tomorrow because it has made me feel like a new woman. What can I say....it is brilliant."
- Vanessa Anthony, United Kingdom
Fantastic news seven!!! 1,600 Stores!!!
"LloydsPharmacy is a community pharmacy operator in the United Kingdom, which owns more than 1,600 pharmacies, located predominantly within local communities and health centres.
Most LloydsPharmacy branches (99 per cent) have consultation areas for customers to speak privately with a pharmacist – more than any other pharmacy chain.
It has around 17,000 staff and dispenses over 150 million prescription items annually."
Pulsed Electromagnetic Fields—A Countermeasure for Bone Loss and Muscle Atrophy
Diane Byerly, Johnson Space Center
Marguerite Sognier, Johnson Space Center
Dickey Arndt, Johnson Space Center
Phong Ngo, Johnson Space Center
Chau Phan, Johnson Space Center
Kent Byerly, Johnson Space Center
Roy Weinstein, Johnson Space Center
<<Seven NASA scientists working with PEMF to find the best solution to keep Astronauts healthy during space missions. Their objective sounds very similar to the ActiPatch, a wearable PEMF device.>>
"Ultimately, the long-term objective of these studies is to produce a garment incorporating a specifically designed PEMF device to be worn by astronauts as a noninvasive countermeasure."
"Currently, there is a critical need to develop effective
countermeasures for bone loss and muscle atrophy to enable
future human space exploration to the Moon, Mars and beyond.
Progressive muscle atrophy can lead to weakness, fatigue, the
inability to perform efficiently assigned tasks, and compromised
emergency egress operations. Bone loss causes increased risk
of bone fracture and kidney stones, which can also negatively
affect mission objectives and success.
The purpose of these studies is to develop a pulsed
electromagnetic field device for use as a noninvasive
countermeasure to enhance bone retention, prevent or alleviate
muscle atrophy, and augment natural healing/regeneration
processes. This research represents a major contribution
toward enabling humans to live and work safely in space, and
is especially relevant to projected human space exploration.
On Earth, this device could be useful in the treatment of
various muscle diseases, age- and cancer-related muscle atrophy,
osteoporosis, and other bone diseases.
It has become increasingly evident that weak, nonionizing
electromagnetic fields can exert athermal effects on biological
targets. One successful therapeutic application of pulsed
electromagnetic fields (PEMF) is to facilitate healing in patients
with refractory broken bones; that is, bones that are unable to
heal despite repeated surgical procedures. In addition, previous
studies suggest that PEMF might be useful in the treatment of
some muscle disorders.
Although studies on PEMF have been ongoing for more
than 20 years, little is known about the molecular and
cellular mechanisms involved in their beneficial therapeutic
effects. In particular, the field energetics must be precisely
defined and optimized for specific applications, such as
frequencies, pulse shape, waveforms, amplitude, and spatial
orientation. To determine whether PEMF could be used as
an effective countermeasure, scientists developed a device
with accompanying software to enable the precise control
of various parameters. This device will help identify which
PEMF frequencies are most effective in producing a biological
response in bone and muscle cells. Studies at the molecular and
cellular levels will define the alterations induced by modeled
microgravity and the ability of PEMF to reverse the alterations
related to muscle atrophy and bone loss. Ultimately, the
long-term objective of these studies is to produce a garment
incorporating a specifically designed PEMF device to be worn
by astronauts as a noninvasive countermeasure.
In collaboration with the Engineering Directorate at Johnson
Space Center, we developed the required hardware and
software enabling the assessment of various PEMF frequencies,
waveforms, and pulse durations. In addition, we created a signal
monitoring/feedback capability for stable magnetic control and
a Helmholtz coil design, and we performed a full simulation
before construction. This device and the associated software
will help identify the most effective PEMF parameters for
space-induced bone loss and muscle atrophy. We performed
the field characterization of the magnetic fields in terms of
frequency, sine wave/pulsed inputs, frequency response, field
amplitude, and harmonics."
Come on dd, you have been around long enough to know that the OTC Pinks have NO After Hours Trading. This OTC Market link shows the official OTC closing trade for BIEL at 15:59:06 at .0011 . http://www.otcmarkets.com/stock/BIEL/quote .
The Form-T trade listed below took place during regular hours but was not reported by the MM until 7 minutes 37 seconds after the OTC Market had closed. The MMs have various reasons for doing this as the article that I posted explains.
Your link is from the NASDAQ Market. BIEL currently does not trade on the NASDAQ. In a few years when the SP hits $4 they will qualify and will probably transfer to the NASDAQ. Then you can trade them AH. Patience dd, patience.
23 16:07:37 0.00098 8,900,000 form t nasd 0.0009 0.0011 8,900,000
There are no After Hours Trades in the OTC Market that BIEL trades in. The "Form-T Trade" that is listed a few minutes after the market closes is explained below courtesy of IncrediblePennystocks :
What is a Form T-Trade?
There is much confusion and rumor regarding “T Trades” in the penny stock market. Nasdaq Pink Sheet stocks often close at a certain price and, within 3-10 minutes after the closing bell, will show a large final trade that gets labeled as an “after hours” trade. Simply put, this is an inaccurate description of that trade.
To understand how this trade works, one must understand the role of the market maker. The most frustrating aspect of investing in the pennies, is market maker manipulation of the stock price. Anyone that claims this manipulation doesn’t happen truly does not understand the OTC Market. Market makers are in place to “control” the price of a stock and, theoretically, to ensure that the market reacts properly to supply and demand for a certain stock. Unfortunately, when large sums of money and a lack of regulation are involved, more often than not, there is manipulation that suits the needs of certain investors or the market makers themselves. After all, they are in business to make money as well. If the average investor is purchasing stocks in the OTC Market, that investor is truly at the mercy of the market makers involved in the purchase and sale of that security.
When researching this article, The response from the SEC defined a “Form T Trade” a “trade reporting form used by broker-dealer members of the Financial Industry Regulatory Authority, Inc. (FINRA) to report equity trades executed either in the OTC market or during extended hours trading. Recent amendments to FINRA rules will expand the types of situations in which Form T is to be used, but they are not yet in effect.” The response also recommended contacting FINRA. Notice the first portion of the response. “either in the OTC Market or…” Once again, it is confirmed by the SEC that ”after hours” trades do not exist in the Pinks.
FINRA was much less transparent in their response and essentially spewed the same limited information regarding T Trades that is available on their website. None of which, accurately reflects why these trades occur in the OTC Markets. (http://www.finra.org/web/groups/industry/@ip/@reg/@notice/documents/notices/p123750.pdf)
Trying to decipher the meaning of these trades with the limited information that is available on the subject led down several dark paths. Clearly, the average investor is not meant to understand the concept or its rules. Even more disconcerting is the second part of the SEC message “Recent amendments to FINRA rules will expand the types of situations in which Form T is to be used, but they are not yet in effect.” That means there is even less transparency about this mysterious T Trade.
After months of due diligence, there are a few poorly publicized uses for a T Trade. The most important factor here is that the only requirement of market makers by FINRA is that they must report all trades in a day. They are not required to do so when the actual trade occurs.
To avoid creating “an unbalanced market”, market makers often do not report certain trades during the day to the public and then use a T Trade not to “scare” investors into thinking a market for that stock is going in one direction or the other at the spurring of one large investor.
If a market maker wants to accumulate a large amount of a stock in one trading day, that market maker may actually not report any of the trades that occurred until the trading day has ended so as not to alert the market to the collection. This practice is completely legal under the FINRA rules of the OTC Markets so long as the trade is reported at the end of the day.
To execute a Market on Close” order, a market maker may have an order to purchase the stock at a certain price at the end of the trading day. This is the most unlikely scenario because it needs to be assured that someone selling the stock and someone buying that stock are agreeing upon a price. Simply put, this is more likely with insider buying and selling.
The T Trade that the public sees is nothing more than one or all of the above scenarios. The T Trade reported at the end of the day can be from one market maker or many involved market makers. It can be a single purchase price but is usually an average of all of the previously unreported purchases from that business day.
Penny stocks are an exciting and lucrative business. As most everyone will tell you, it is not for the weak of heart. There is definite money to be made in the OTC Markets and more penny stock millionaires are made every day. But the best way to win the game is to know the rules!
I believe that you have hit the nail squarely on the head Simpsonly.
1.spoken or written words that have no meaning or make no sense.
2.foolish or unacceptable behavior.
Good call art! The planets are aligning for BIEL. Sales in Q1 tripling due the excellent work of Dr. Kotak in the UK. Over 12,000 ActiPatches sold in 1 month of Q2 by Boots. The German Icon B.Braun handling RecoveryRx distribution in the UK. Canadian sales showing good promise for this year. The FDA acknowledging that Tylenol & Motrin are killing customers.
The BIEL train has definitely left the station!! Get on board or get out of the way!!
seven, So glad to see that the FDA is finally acknowledging the ever building body count that results from the use of Ibuprofen (Motrin) and Acetaminophen (Tylenol). It would be a very good time for the FDA to remove the road blocks for a proven pain reliever that has ZERO SIDE EFFECTS. They could be the heroes, making a non drug pain reliever available to the American people as the truth about the dangers of Tylenol and Motrin scares people away from them.
Thanks seven. Lots of good info. I particularly like this quote from Dr. Kotak:
"The products have clearance in more than 50 countries around the world. The safety of the products is clearly proven. The company has sold 500,000 units (more than 40,000,000 treatment days), with no reports of adverse effects."
40 million treatments and no negative side effects. This is an amazing safety record.
I had not seen the 2014 Dr. Rawe "Case for OTC Shortwave Therapy" that is referenced in the interview. It has some eye opening statistics about pain in the USA:
* Up to 100 million people suffer from chronic pain each year
* $635 billion is spent to treat chronic pain each year
* 107,000 Arthritis patients are hospitalized each year due to use of NSAID pain relievers like ibuprofen (Motrin)
* 16,500 Arthritis patients die each year due to use of NSAID pain relievers like ibuprofen (Motrin)
* Acetaminophen (Tylenol) is responsible for one half of all Acute Liver Failures
* Deaths caused by Opioid Pain Killers have quadrupled in the last 15 years
Great chart seven! In the case of Nurofen, an ibuprofen product, you not only pay more for pain relief but you get the following possibilities:
You should check with your doctor immediately if any of these side effects occur when taking ibuprofen:
More common
Abdominal pain
acid or sour stomach
belching
bloating
cloudy urine
decrease in amount of urine
decrease in urine output or decrease in urine-concentrating ability
diarrhea
difficulty having a bowel movement (stool)
excess air or gas in stomach or intestines
full feeling
heartburn
indigestion
itching skin
pain or discomfort in chest, upper stomach, or throat
pale skin
passing gas
nausea
noisy, rattling breathing
rash with flat lesions or small raised lesions on the skin
shortness of breath
swelling of face, fingers, hands, feet, lower legs, or ankles
troubled breathing at rest
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
weight gain
Less common
Abdominal cramps
stomach soreness or discomfort
Rare
Agitation
back, leg, or stomach pains
bleeding gums
blistering, peeling, loosening of skin
blood in urine or stools
bloody, black, or tarry stools
blurred vision
burning feeling in chest or stomach
change in vision
chest pain
chills
clay-colored stools
coma
confusion
constipation
cough or hoarseness
dark urine
decreased urine output
depression
difficulty breathing
difficulty swallowing
dilated neck veins
dizziness
dry mouth
extreme fatigue
fast, irregular, pounding, or racing heartbeat or pulse
fever with or without chills
frequent urination
general body swelling
general feeling of tiredness or weakness
hair loss, thinning of hair
headache
hives or welts
hostility
impaired vision
increased blood pressure
increased volume of pale, dilute urine
irregular breathing
irritability
itching
joint or muscle pain
lab results that show problems with liver
lethargy
light-colored stools
loss of appetite
lower back or side pain
muscle twitching
nosebleeds
painful or difficult urination
pains in stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rash
red skin lesions, often with a purple center
red, irritated eyes
redness of skin
seizures
severe abdominal pain, cramping, burning
severe and continuing nausea
sore throat
sores, ulcers, or white spots in mouth or on lips
stiff neck or back
stomach upset
stupor
swollen or painful glands
tenderness in stomach area
thirst
tightness in chest
unpleasant breath odor
upper right abdominal pain
vomiting of blood
vomiting of material that looks like coffee grounds
wheezing
yellow eyes and skin
Symptoms of overdose
Bluish lips or skin
difficulty sleeping
disorientation
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
drowsiness to profound coma
hallucination
lightheadedness or fainting
mood or other mental changes
muscle tremors
not breathing
rapid, deep breathing
restlessness
slow or irregular heartbeat
stomach cramps
sudden fainting
sweating
Some of the side effects that can occur with ibuprofen may
Great find yankee! Boots sells the ActiPatch @ 19.99 BSP which translates into $30.78 USD at the current 1.54 exchange rate. So 12,000 (although the post says more than) units @ $30.78 = $369,360 at the retail level in May. That is just one month out of the 2nd quarter and is only the Boots sales.
We had close to a 300% increase in Q1 2015 vs Q1 2014. It now looks like Q2 2015 will be as good if not better.
I would say that it is for Canadian residents only. However any US resident can order the PetPatch Loop (same as ActiPatch) for their pet mule from Heal Fast.
http://www.healfasttherapy.com/
A very solid day for BIEL. With a 32 million total volume, 28 million was @ .0011 or higher.
9.1 million shares @ .0011
4 million shares @ .001184
15 million shares @ .0012
Thanks seven. "Sold by Actipatch and Fulfilled by Amazon."
Having a major online player like Amazon involved in Canada is a great move.
shadolane, While I agree that BIEL's main focus should be on selling products in the 40 countries that have authorized their use, the US is too large a market to take a "whatever" attitude.
The FDA is a Federal Government Agency that was established to serve US citizens and is funded by everyone that pays Federal taxes. Congress has over site powers and controls FDA funding. The President appoints and can dismiss the FDA Commissioner. The Judiciary can review any FDA action or inaction. Public opinion can also shine a bright light on the FDA.
On 5/1/2015 Congress held a hearing titled "What is the Federal Government Doing to Combat the Opioid Abuse Epidemic? The guest of honor was an FDA Deputy Director. Last year Senate Health,Education & Labor Committee heads Tom Harkin & Lamar Alexander formed a Prescription Drug Abuse Working Group. Harkin said "The abuse of prescription painkillers and narcotics has grown into a bona fide public health crisis, affecting virtually every state, city, and small town in the United States. Too many Americans and their families have suffered from the effects of this insidious epidemic".
Last year when FDA Commissioner Margaret Hamburg ignored her advisory panel's decision that a powerful new opioid drug, Zohydro, should not be given FDA approval congress held a hearing and made her explain her actions. Several anti-drug organizations called for Hamburg to be fired for approving Zohydro. Hamburg resigned in February 2015.
The FDA is most definitely NOT untouchable. They are accountable to congress, the president, and public opinion for their actions and inaction. Prescription Drug Abuse is a hot issue right now. PEMF has been proven to reduce the need for drugs and the reclassification should be on a fast track for approval by the FDA rather languishing for the last 16 months.
http://dash.harvard.edu/bitstream/handle/1/8852216/Cook.html?sequence=2
One final check on agency discretion and policies lies outside of the constitution – the public. The American public keeps careful watch on the FDA’s activities, more than any other regulatory agency. And this public interest in the laws concerning food and drugs makes sense, given that all humans need food and medicines, and all humans have preferences and opinions about which products are safe. Thus the public, through the media, internet services, and general fascination in the American Presidency, is able to monitor and influence the FDA’s activities.
In addition to the national public and the media, Congress polices the activities of the FDA. Although the FDA is located in the executive branch, Congress still possesses multiple mechanisms to control the agency. First, as alluded to above, the Senate has the power to decline to approve the president’s nominee for commissioner of the FDA.[14] Though most nominees are approved, the confirmation hearings still provide the Senators with a highly publicized forum to air their concerns about regulatory matters and to extract policy commitments from nominees.[15] The FDA, like every agency, needs a minimum degree of legislative support if it is to maintain its programs and obtain funding for them.
In fact, Congress requires FDA officials to testify before its committees more than any other agency.[16] Congressional oversight influences the content of FDA’s requirements and the efficacy of its enforcement powers. Significantly, the Congressional power to oversee the activities of regulatory agencies can be exercised as a means to reign in the president and his administration.[17] If the president is of a party different from that of the party controlling Congress, Congress can seize its oversight powers, requiring agency testimony, holding hearings, etc. For example, the arrival of Republican President Reagan in 1981, combined with the change in party control of the Senate, significantly reduced Congressional oversight, but Congressional pressure resumed following the Senate elections in 1986.[18]
In spite of these apparent Congressional “checks” on agency power, some scholars have questioned whether the increased use of hearings and other public oversight tools, represent a decline in Congressional power over agencies rather than an emergence of power.[19] That is, the Congressional oversight of agencies occurs in committees or subcommittees not on the floor of the House or Senate.[20] Not to mention Congress cannot impose statutory -- and most budgetary -- punishments without the agreement of the full Congress.[21] This would involve overcoming significant collective action problems and incurring transaction costs. Moreover, Congressional oversight tends to conserve the status quo, since Congressional committees usually focus on administration in reaction to strongly registered complaints by constituents. Therefore, although agencies must answer to Congress, they often are able to proceed without too many Congressional hassles.
B. The Judiciary
The courts’ review of agency action (or inaction) furnishes an important set of controls on administration behavior. Different from the political controls exercised through OMB review (described below) or Congressional oversight, the judiciary regularly operates to provide relief for the individual person who is harmed by a particular agency decision.[22] In fact, sometimes judicial review might even counter the oversight activities of the executive and Congressional branches.[23] Judicial review can provide legitimacy of agency regulation, by providing an assumed objective and independent check on administrative decisions.[24]
A letter to the President is certainly worth a try bieliever.
All of the 40 countries listed below allow their citizens to purchase PEMF devices like the ActiPatch. Conspicuously missing from the list is the United States which consumes 80% of the world's pain medication. It is time for the US FDA to join the rest of the world and give US citizens access to drug free PEMF technology. Please write your Congressman and Senators and request their assistance with convincing the FDA to finish the 6 month (FDA time estimate) Shortwave Diathermy Reclassification (the FDA term for PEMF), Docket No. FDA–2012–N–0378, that they started in 2/2014 but have not completed.
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Great Britain, Korea, Italy, Canada, Australia, New Zealand,
Nigeria, Iran, Jordan, Kuwait, Peru and Columbia
Thanks Yankee. It has been a long haul but all of the pieces are now falling into place.
The UK gives customers an ActiPatch Refill option at a 20% price reduction to the full Back/Knee/Muscle-Joint products. Smart Sole Refill offered at a 25% price reduction. Looks like they are fine tuning their product options for the market.
http://www.tryactipatch.co.uk/collections/actipatch-products
More Uk Pharmacies stocking the Actipatch.
https://www.weldricks.co.uk/seasonal/cat/new-products/sort/alpha?t=all-products
This has got to be a very late April Fools post. Q1 2014 $169k Sales , Q1 2015 $503k Sales. That is a 297% increase in sales in one year. Any company on this planet would sell their soul for that kind of sales growth. Q2 2015 will show more explosive growth as Boots added ActiPatch to 275 new stores on 4/1/2015, nearly doubling the availability to British consumers.
The SP of BIEL has dropped because the FDA is 11 months late in meeting their own 6 month timeline for the reclassification of PEMF devices. BIEL has no control over the sloth of a large government bureaucracy like the FDA. However, as Bioelectronics VP Dr. Kotak stated, BIEL will be successful with or without the FDA.
Someone may have already talked to the boys at Homedics. If you go to their website there is no mention of the iHeal, just a Tens unit called the Rapid Relief. A search on their website for "iHeal" turns up No Results.
They probably had a problem with this item, legal or otherwise, and blew out the remaining stock to Amazon.
http://www.homedics.com/catalogsearch/result/?q=HoMedics+iHeal+Tissue+and+Cell+Repair+Unit
This is embarrassing. He is going to be predicting Armageddon when .01 is printing.
Today was an instant Classic! Dow down 350 points, NASDAQ down 122, S&P down 43, and our little BIEL up 11%. Pretty amazing, but wait, it gets better. A look at the OTC Short report shows that out of a 16.7 million share volume 13.3 million shares were shorted. This is not a misprint, nearly 80% of the shares sold today were either borrowed or do not exist.
100% correct yankee! Chris Sale has a $32.5 million 5 year contract with the White Soxs. Money is no object for his team doctors to get him back in the game as quickly as possible and they went with PEMF.