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Rounding error art - I suspect it should be 110Billon shares, not 111Billion. I wonder if the other 1Billion shares are preferred?
No apology needed jlh - it's all so obvious to those looking only at the facts, without an ulterior motive
Wow, so bitter. Please tell us, are you or were you a shareholder, or an ex-employee?
Thanks very much for your kind words yankee.
Combining my post 39330 and your 39343, this BIEL related question arises.
Instead of the country going tilt over yet to be proven allegations about long wait times for veterans at VA facilities and calling for the firing of VA Secretary Eric Shinseki, who has never had anything to do with wait times, ever, would it be a good time for someone courageous in DC to demand an immediate assessment of the allegation that VA doctors are writing more pain medication prescriptions than patients seen? Are we staring the biggest drug ring in history in the face, or are we just drugging vets out of their minds, or both? The White House should jump all over this opportunity to help our veterans.
No wonder wait times may be too long, it's the time taken to write all those idiotic prescriptions for the tens of thousands of painful knees, backs and arms you mention! One ActiPatch for pain, leave it on for 720 hours and you don't have to go back for another one for 30 days! And no side-effects! No addictions, except to get your hands on another ActiPatch to treat the pain!
Imagine that! No more waiting, just pick up your replacement ActiPatch, hell, we'll mail it to you. Now there's an idea waiting for its time! Did I just get rid of the long wait times, all those painful appointments waiting for the prescriptions and the thousands of doctors writing all the painkiller prescriptions? Wow! ActiPatch delivered to your residence. Seems like we just saved the VA and the American people hundreds of millions of dollars, maybe a couple of Billion, in lost time away from work, VA doctors, pain drugs and treating side-effects and addictions from those drugs. Wow, all in one shot!
Am I biased? Yes, I'm long BIEL. Is the timing right to make a definitive statement about painkillers and veterans? Never better, it's Memorial Day weekend!
Smart Mary! She's long BIEL and now has his number when he agrees with her too quickly!
Thank you yankee - I'm honored by your words about me and, more than that, I appreciate your message about remembering those, from the past and currently, who have given their lives, minds, bodies and personal and family sacrifices, to protect our freedoms and the way of life of the free world we are so fortunate to be part of.
Thinking about that, I also hope BioElectronics can develop a field dressing using ActiPatch for the US, our allies, and the UN armed forces for pain management for minor issues, especially during exfils and while transporting slightly injured. Treat with splints or slings, medicate with tetanus and antibiotics and slap on an ActiPatch and dress it, good for 720 hours.
Ex-Marine Whelan will get that in a second. If it were me, I would be contacting the JCS, DOD or defense.gov on that opportunity and giving them 500 ActiPatches to try. No drugs, no chemicals, no allergic reactions or side-effects, no spoilage, just pain relief. And for equipment operators or maintenance people, or the USAF, no drowsiness if you work on the birds or fly them. All good.
Mary - folks who are long BIEL shares must remain positive. But, your husband is simply saying, nicely, that whatever you say, you are right. Very smart fellow, do it myself, often. . . . :)
Okay - but your question may be more appropriately directed at reclassification of what, rather than just "reclassification"?
Yes, the FDA would like comments in the next month to its Proposed Rule Document dealing with 21 CFR 860.***etc regulations. But, that category seems to deal with implantable devices. It also seems to be a deep housecleaning process.
From the link in iHub post 39200 - the coalition submission to the FDA by various manufacturers that may be in the same space as BIEL, it would seem that their and BIEL's products fit into category 21 CFR 890.5290 and not into 21 CFR 860.***.
The document I accessed from the link you provided is beautifully written. . . . .
Seems FDA wishes to streamline and the document sets out that intent clearly. Don't know if this is the sort of thing you were looking for?
He may have meant it might go only as high 35 to 40 cents, rather than a dollar as speculated perhaps in jest by 7up :)
It is interesting to note that in the highly professional 89 page coalition submission to the FDA prepared by Dr. Richard Isenberg VP Clinical & Regulatory Affairs of Regenesis Biomedical, there is no response to the FDA question found in Section XII of its request for comments as to whether the 60 period for applicants to prepare and submit 510K applications is sufficient time. I expect Dr. Isenberg would concur with my expressed opinion that 60 days is sufficient, but it is easy to see how the smallest points can be so easily overlooked. Who knows, I may have overlooked 3 or 4 as well, easy to do.
Of course, if Dr. Isenberg did indeed address that question in the coalition submission, then I completely missed it, twice, and I bow my head with great humility in apology.
good grab wyatt - thank you.
I read the coalition submission to the FDA with much interest.
Note, the submission covers all coalition products emitting at a frequency range of between 13.56 MHz and 27.12MHz.
Guess where BIEL products are at.
BAM - right at 27.12MHz.
from BIEL website:
QUOTE
BioElectronics medical devices are pulsed shortwave devices that have the following specifications:
Carrier frequency 27.12MHz
Peak spatial power density 73 microwatts/ cm²
Pulse rate 1000 pulses per second
Pulsed on duration 100 micro seconds
Power source Battery
Antenna size 12cm or 8cm
Treatment area 100cm2 of 70cm2
Weight 8 grams
Operation time 720 hours (on/off capability) or 170 continuous hours.
UNQUOTE
I had a momentary concern that BIEL might fall outside the coalition parameters - not true.
To h--- with BIEL art, I want to know the octane of whatever you had for lunch. . . . Holy S!
My sense art is that there is solid intel to be found in one word in post #39145, thanks to 7up.
QUOTE
Over 400, I just spoke with FDA and they will review the comments of course, she could not give a exact time frame.
But she indicated they were interested in moving it along.
It was a good conversation and a quick returned call.
Very positive response...
UNQUOTE
The word is "interested", I believe that word was used and its usage speaks volumes. Combined with revealing there were over 400 submissions, I can attest to the potential accuracy of that because I personally verified the number at 286 not long before the closing of submissions. My test as to the veracity only works one way, of course, if the posted answer was "around 250" or anything <286, I would know that not to be true! Nothing personal in my checking 7up, I'm checking my own intel 3 times to make sure I’ve got it right. I happen to believe in credibility and although none of us have ever met, I believe it's important when people may be relying on you to be deadly accurate and not wing it.
So, my take is this is more how the conversation went;
7up, "Can you tell me how many comments you've received?"
Response, "we received over 400"
7up, "So what happens now?"
"Well, we have to review them all"
"How long will that take?"
"Well, I can't give you an exact time frame, but we are interested in moving it along"
7up, would you please confirm if this is at all close, and if not, would you please correct it as accurately as you possibly can?
Here's where I'm going with this and jump me if you think I'm reaching. . . . .
FDA proposes a new classification and asks for comments.
They got over 400 and are interested in moving the file along.
FDA asked for feedback to its question - is 60 days long enough for parties to submit 510K's after an order is given and I know they got feedback on that as affirmative.
The folks at the FDA are real people with families and they all have relatives and friends and perhaps themselves with aches and pains, muscles, joints, arthritic, pulls, sprains, tears, bruises and menstrual and I'll wager over 90% have taken pain drugs for minor ailments. I happen to believe that women, mothers, are the pivotal influence in most families. I never heard my father ask me to drink my milk or orange juice, or take my medicine, it was mostly my mother! So, my take is that folks at the FDA see all these things going by and think, "what if this ActiPatch works? There is a lot of attention being paid to non-drug solutions these days, hmmmm". And some are looking at ALLAY and going Hmmmmmmm.
They've all got mothers and fathers art, many have the kind of temporary aches and pains ActiPatch can deal with effectively. I also have not known of one woman with chronic menstrual cramps and pain who took a couple of days off work and went sailing. What I have seen is many women who were so stricken with this recurring malady that it turned their lives and those of family members upside down, month after month after month for years. No one fakes that misery. You watch art, the FDA will be handing out ALLAY as an employee benefit and reaping the rewards of healthier, happier women in its workforce, improved productivity and reduced sick days. Remember where you heard it. Women are the pivotal party of pain management in America and when the opportunities of ActiPatch and ALLAY break here, it will be American women who make it fly by simple word of mouth, "have you heard about ActiPatch and ALLAY?". How many people can you think of who would buy these products over pain drugs?
Actuals
Date 9/12/09
Market Cap $162,240,000
Sh Price $0.12
OS 1,352 Bill
AS 1,500 Bill
Assumptions:
Date June, July, Aug 2014 ??
Market Cap $162,240,000
Sh Price $0.031
OS 5,290,837,411
AS 6,000,000,000
Date ??
Market Cap $300,000,000
Sh Price $0.057
OS 5,290,837,411
AS 6,000,000,000
Date ??
Market Cap $500,000,000 ??
Sh Price $0.095
OS 5,290,837,411
AS 6,000,000,000
Further Assumptions:
1. Has the FDA proposed a new classification which fits with BIEL products? Yes
2. Has the FDA mandated comment period expired? Yesterday
3. Does BIEL have more trial data now than in 2009? Yes
4. Are US govt and people ramped up re pain drugs? Yes
5. Does the US consume 80% of the world's pain drugs? Yes
6. Is BIEL worth at least what the market said it was worth in 2009? To be determined
5. Is it worth more and if so how much more? To be determined
Hey Super, a little surprised. but of course you do your own thing as you see fit.
Permit me to offer up some quick thoughts, please.
If you are correct and I do accept what you say because of your credibility, as opposed to others. . . .
6 Billion shares
Trading at .0026 cents!
A whopping $15.6Million in market cap.
I will not care about that little item if the stock stays at .0026 cents until somewhere in the region of, oh, about38.4 BILLION shares as a businessman, I happen to 'feel' that I would pay $100 Million for BIEL today, to own what it has, with the confidence that I will do very well, thank you.
Let's just say it goes something like this. . . . .
"Mr. Whelan, my 9 associates and I would like to personally invest in your company, giving ourselves 75% of BIEL, which will be approx. 4.5Billion shares at a maximum price of .0075 cents, or $33.75 Million, that's $3.375Million for each one of the 10 of us. You're in your 70's Sir, we have the horsepower here at our company to take the good work you have done so far and move it along to a level in our company that you will be very happy with and we believe the risk to us given that the FDA has proposed that it create a new class of devices that your products will fit into and given that you have solid trial data and given that your products are patented and drug and side-effect free, we feel we will make a great team and that BIEL will be a winner with you retaining 25% of the equity in the company."
Today a market cap of $15.6 Million? Tomorrow?
I repeat my often asked question, who is buying the shares? Need I say more?
Just wanted to throw a little perspective on it Super. $15.6Million - hell, if I had the change to throw at it, I would buy the thing and some days I feel I have, believe me. Cheers Super.
Thank you yankee - individual recognition is always appreciated by all, but I take delight in being part of a group, a team, of "Good Guys, men and women who are espousing the concept that patented, drug-free, side-effect free control of pain while stimulating healing is a far better and safer way to go than taking pills! iHub provides us the opportunity for current, and past posters who are most assuredly sitting quietly on the sidelines watching, to keep abreast of current news and thoughts.
Takes a lot of effort and energy for posters now and over the years to do what they have done, but I believe it will be worth it when I think of the damaging chemicals we put into our bodies with Rx and OTC pain remedies, when it appears we may/will no longer have to, to the extent we now do.
Am I also in this to make money? No question. But, I also love the idea of helping this cause for drug-free pain management to move forward in order to benefit the American people. If as and when it takes off here in the US, sales in many other countries will grow tremendously, as there is a hugely positive cachet to "FDA approved". I don't think I'm getting ahead of myself here, it's a well known fact that FDA approval influences sales in other countries.
Hey ravens - I still find it interesting that Whelan was quoted recently as saying that at one point they, BIEL, did sell shares to finance their ongoing operations but that he wouldn't do it now at these low prices. If, and I say if carefully, it is not BIEL or Whelan interests selling shares now to finance operations, then who and why are the shares being sold, and more importantly, who is buying them? Are the higher volumes only MM's and other day traders catching the shifts in price, or is there a buyer out there accumulating shares? I wish I knew the answer.
Good on ya Sugah - fond memories of OZ many years ago on assignment there for 2 years. The only Sun in NSW is in Parramatta and I knew it wasn't that one. Thanks for the feedback - cheers
Hey Josh are you able to check the Sun archives on-line in the UK? I suspect it is the last 3 days from Sugar's post?? He/she said "featured" - that means something as opposed to a small ad somewhere.
Hey Sugah - I assume you are a signed up reader of 'The Sun', or are in London or surrounds and have a copy of the issue that has ActiPatch featured in it.
Would you be so kind as to please take a photo with your mobile device and post it here?
Thanks very much
I believe I understand, you are in now way part of the problem with such bashers, it's always an issue with stocks and trading on Pinks. . . . ., I have same issue
Hi sausage - I suspect it may be Gro International - remember?
Gregor Forbes - ex P&G.
http://www.prnewswire.com/news-releases/gro-international-to-develop-bioelectronics-otc-brands-in-european-and-african-markets-191198971.html
Or, perhaps BIEL dealt with Boots direct?
Interesting to see that Dr. Ian Rawe, Director of Research, BIEL is quoted in that news release behind the link you provided lever - love the teamwork that Whelan seems to be stimulating more of now.
Hey lever - BIEL has so much going for it now that the bashing becomes less effective every day. I use ignore and it works well - I must admit I do look at some posts I would otherwise not see when one of the GG's respond to the aggravating nasties. Don't blame you and super and the rest of us from responding. Perhaps you might elaborate on your idea over time? Even by multiple innuendoes?
Gotcha edbi, thanks - It will be interesting to see if the press releases reach out to the coast, CA, and throughout the investment community on the eastern seaboard - I don't know the reach of such electronic PR's these days, but if it is quick and far-reaching, I can't imagine the investing public not checking BIEL out, given the newsworthiness of pain drug issues in the US today. Who doesn't take painkillers, from Tylenol to whatever and regret doing so most of the time?
Hey edbi - I took the trouble to independently verify your post re BIEL related PR this morning. Not out of mistrust, but for my own personal satisfaction and found this. It's slightly different in content, were there two releases?
QUOTE
press release
May 12, 2014, 7:30 a.m. EDT
BioElectronics Corp. A Sub-Penny Opportunity in Health Care Industry Analyst Report
NEW YORK, May 12, 2014 /PRNewswire/ -- BioElectronics Corp. BIEL +7.69% One-third of the world's population suffers from chronic pain and many go untreated due to the lack of efficacious therapy, the cost, and the dangerous side effects of drug therapy. Chronic pain is pervasive throughout the world. Pain affects more than 100 million Americans, which is more than diabetes, heart disease and cancer, combined.
BioElectronics Corporation is a leader in biophysics and the maker of an industry leading family of disposable, drug-free, anti-inflammatory devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy; and HealFast® Therapy for dogs, cats and horses.
The underlying concept of the BIEL product line is to replace the short duration, high power treatments which can only be obtained in the clinic by a trained professional, with an easy to use, self-administered, very low power device that can be used 24 hours per day.
A full report on BIEL that includes risk factors, industry review, financial position, potential revenues, and review of current business model, competition breakdown, analyst summary, and recommendation can be viewed by using the following link:
http://bit.ly/BIEL-AnalystReport
UNQUOTE
Well done art - MightyMeow, what are you doing commenting on a post by stockdarock, a moderator here, on his post from August 2013? Were you going through his posts and thought you found the mother-lode of negativity to somehow inanely reinforce? Tell me this is not a basher's mistake. I accept that you were confusing your positive views on BIEL and its products and your frustrations with Whelan's past errors in management, seemingly now resolved, but this is just nonsensical. Whatsup? Care to explain? Thanks.
thank you for this edbi46!!!!! In my opinion, when E-TRADE gets on board with a recommendation like this, Game On!! Only a matter of time before other trading platforms and brokerages join in, cause in that world, it's ALL about commissions folks.
Hey MightyMeow.
Atrocious? Yes, I agree. Bumbling, which is atrocious when seeking FDA approval.
Criminal? Not my business.
BIEL to me is about the products and the patents and being drug and side-effect free.
I believe Whelan and his stubborn personality, lack of management experience and ego botched the first FDA application process.
On balance, FDA admitted it didn't have experts in house, published its intent to hire same, proposed a public meeting in 2013 to hear submissions, has seemingly totally reversed its earlier position on PEMF - SWT therapy devices and proposed a new class of devices to house them.
Further on balance, BIEL's 2008 - 2009 submission was not the best, trials were simplistic and data unclear. On the other side FDA didn't get the science, now it does.
I say, let's move on. I've used ActiPatch and it is terrific. I can only imagine what ALLAY will do for 10's of millions of women globally with monthly menstrual pain and cramping. I have no interest in jousting with those hung up on bitterness, bashing avarice or just general troublemaking, those involve character issues. Often people are stuck in a pronged fit of pique, most of us have moved on to the real issues.
Drug and side-effect free, patented pain management that stimulates healing as a bonus, that, if approved by FDA, could make safe pain management for many issues available OTC to the American people who currently consume 80% of the world’s chemical pain medication annually! What!!
Your post talks about posters here being intolerant of criticisms of BIEL. Correct. Because your post, please read your own words again carefully, in my opinion, confuses the foibles of management of yesteryear with BIEL and its products. Clearly, you like the products and what they do. Stick with that focus. In my opinion, management has gone to the precipice of mismanagement and nearly fallen into the chasm, BUT has survived and learned and brought highly professional outsiders onto the team and FDA is now quite positive on the science involved. Defame Whelan all you like on the first, but credit the man, an ex-US Marine, for hanging in, surviving and having the sense to listen and learn from past mistakes. Same man in both scenarios, had he not hung in we would not be having this discussion, so he therefor deserves credit where it is due and our respect for making positive changes. Am I happy about a 5 year delay and financial jeopardy? No. Can I do anything about it? No. Do things seem very positive at the moment? Very much so. I fervently hope Whelan let's the pros he has brought on board do their jobs with the FDA with great diplomacy, so we all win. Ergo, patience.
Hey Josh - I think we'll possibly see 4 price moves:
First, when the FDA request for comments to its proposal to create a new class of devices, which BIEL could be in, if approved, i.e. Class II and approved for OTC sales in the US expires May 21;
Second, when FDA publishes that it has created the new Classification it's proposing;
Third, when BIEL files a new 510K application for consideration for the new classification; and
Fourth, if, as and when FDA approves the BIEL application. BIEL says it has it's application requirements in good shape, trial data, etc.
Do some DD, check out FDA publications, they are pretty positive.
What the price moves might be, would be foolish speculation, what the price fall-offs might be during waiting periods. Just as foolish.
How very gracious of you Mary, thank you!
You and yours as well yankee.
Here is some interesting FDA reading material on the proposed reclassification matter - you've probably been through it carefully before.
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/orthopaedicandrehabilitationdevicespanel/ucm352560.pdf
Fair enough Arizzle, I was thinking more along these lines. . . .
http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/
Although, I underestimated current costs all-in to get an NDA completed start to finish - I was under the mistaken thought that the cost was $1Billion for an NDA, the above article says $1.3B.
In light of these numbers, I still don't feel that $24Million for any level of FDA approval gets you a good lunch these days - expensive arena to play in. As I wrote earlier, I was involved in a patented oncology drug development and we met the FDA re applications and approvals. They were great, prepared to help us quickly through approval processes, we didn't have the required $88Million, which was actually peanuts, so we stuck to the EU and are profitable. Just my take on what $24Million gets and it ain't much these days.
Apology - I did not mean to attribute the last 2 paragraphs of my previous post 38075 as quotes from Michael Drues' comments; they are solely mine and my opinion only.
Hey Arizzle:
Looked for the info you posted about, as I suspect the average costs associated with obtaining FDA approval are much higher than the $24Million you mention - many trials cost more than that!
However, I did spot this info and provided the link to it below for verification.
Repeat after me: The FDA is not an obstacle or hurdle that I need to get around or over in order to get my product in the marketplace.
That is the message that Michael Drues, president at Vascular Sciences, a consulting firm offering business development, education and training among other services, wants to convey to the medtech world. Drues says he finds it unfortunate that many in the medical device world construe the agency as largely a workaround, whereas considering them a partner would be far more effective in getting products through the regulatory process relatively painlessly.
At the same time he acknowledges that medical device companies cannot await eternally to get the FDA nod on their products because they are dealing with finite resources in an arguably difficult and changing healthcare landscape.
In fact, a slow and opaque review process has been a running criticism of the FDA in recent years. Even Congress has gotten involved by asking FDA to be more accountable to industry in terms of how quickly it reviews products.
Still it only benefits medtech companies to have a plan around communicating with the FDA given that it is the gatekeeper charged with ensuring and safeguarding public safety.
Here are a few tips Drues shares that will vastly improve communication with the agency. He will be discussing these in more detail at the MD&M East Conference & Exposition, June 9-12, in New York City.
Don't Just Bring Regulatory Folks to FDA Meetings
One major error medtech companies make is only taking regulatory professionals to meetings with FDA reviewers and personnel, Drues says. After the meeting, those people then have to communicate messages to those that didn't attend.
"I don’t know if you ever played the phone game as a child, where you have a bunch of kids sitting in a circle and one person tells a story to another and another and by the time it comes around to the last person, you have a completely different story," Drues explained.
And that is what happens when FDA meetings are considered the exclusive reserve of regulatory professionals.
Drues noted that sometimes company executives are reluctant to take R&D engineers to meetings because they are worried of what they might say.
"I understand the concern," Drues said. "Treat the engineer like a child. You can tell them, 'Don’t speak until you are spoken to and even if you are spoken to, don’t speak anyway.' I still think there is value to having them in the room than playing the phone game."
He advises companies take a select few from different functions within the company depending on the topic of the meeting. They could be from clinical, R&D or manufacturing functions for instance.
Don't Wait Until A Prototype to Set up Meeting
"It's never too soon to set up a meeting with the FDA, Drues said. There are guidelines as to when companies need to contact the agency, but the sooner the better, he advises.
"I am a big fan of meet and greets," Drues says. "Simply call up the FDA and set up a time to meet with them. Say, 'we’d like to come down and shake hands and tell you a little bit about what we have been doing and what we are doing next.' Don’t ask them for anything."
This is especially true if the company is developing a new and innovative product. Appeal to FDA reviewers as engineers and as people and say how the device could help many people, Drues says.
The Center for Devices and Radiological Health is divided into branches each overseeing a particular segment within the medtech world such as cardiovascular, gastroenterology and each branch can be contacted to set up a meeting. However, if in doubt about which branch and any other query, people should not hesitate to contact CDRH's Division of Small Manufacturers, International and Consumer Assistance, Drues advises.
Don't Ever Ask FDA What You Should Do
There are several things Drues encourages medtech companies to do when it comes to FDA - communicate early, communicate often and communicate honestly especially if there is a problem or you expect there to be one.
But there is a big "don't" when it comes to talking to the FDA.
Never ask them what you should do.
"I see people go to the FDA and ask them what to do and that has disaster written over it in every language," Drues cautions. "You want to lead and not follow."
http://www.mddionline.com/blog/devicetalk/3-tips-to-improve-your-fda-communication-strategy
Rather like asking a malingerer friend how they are; don't do it because they will surely tell you of their latest aches and pains. Or, asking a colleague to review something you've written instead of specifically asking him or her to determine of you've told the story well - all of a sudden you're facing a World Champion Wordsmith, who is re-writing your piece for you.
If you ask a government agency what you should do, you will be buried in information. Keep it short, professional, focused and diplomatic! The piece above also seems to support my earlier suggestion that BIEL should have Dr. Christine Dumas and the scientist and engineering types at the FDA meetings
Hey art - for you and 7up:
I would not be pleased if a large pharma like J&J or GSK picked up BIEL because with global full-press Product Managers and large dollars invested in marketing and sales, ActiPatch and ALLAY just might combine to be a Blockbuster, less than 2.8Million products per month - and that would make large-ped very unhappy. . . . :)
Sorry for the delay in responding 7up.
This is the key information from FDA on its proposal to create a new classification, which would be a home for BIEL's products, and, of course, the products of others in the space, but BIEL is our concern.
I've kept quiet on a couple of theories as to why we are BIEL is in the enviable position it's in at the moment because of timing, so having posted the link to the FDA release again, permit me to make a few observation:
QUOTE
In accordance with section 513(e)(1) of the FD&C Act, the Agency is proposing, based on new information that has come to the Agency's attention, to reclassify SWD for all other uses because general controls and special controls are sufficient to provide a reasonable assurance of safety and effectiveness. Therefore, this order proposes to reclassify SWD for all other uses into class II (special controls) and to rename the device nonthermal SWT; see Section III for more information on the name change. In addition, in this proposed order to reclassify the device to class II with special controls, FDA requires manufacturers of currently marketed SWD for all other uses to submit 510(k)s.
XII. Proposed Effective Date
FDA is proposing that any final order based on this proposed order become effective on the date of its publication in theFederal Registeror at a later date if stated in the final order. FDA proposes that nonthermal SWT devices must comply with the special controls and must submit a 510(k) within 60 days after the effective date of the final order. FDA requests comment on whether 60 days is an appropriate time to allow manufacturers to prepare and submit 510(k)'s for these devices.
UNQUOTE
1. "the Agency is proposing based on new information that has come to the Agency's attention, to reclassify SWD for all other uses because general controls and special controls are sufficient to provide a reasonable assurance of safety and effectiveness.". Isn't this the crux of what is taking place?;
2. Not thinking about it - "proposing to reclassify", pretty damn strong words;
3. "New information that has come to the Agency's attention" - not asking for new information - we already have it and on the basis of it we're proposing creating a new classification;
4. And . . . . FDA believes general and special controls are sufficient to assure safety and effectiveness. So, if you come to the Agency's attention - the agency doesn't want a compliance management nightmare and believes that if a party complies, it's good to go;
5. I know I'm bouncing around a bit - "and to rename the device nonthermal SWT" I would love to see the black and white that BIEL's products comply with this now, since there has been much talk about the subject;
My personal conclusion - The FDA has stated that the reason it is proposing it create a new classification of devices is because of new information that came to its attention, information about thermal versus non-thermal and that it obviously agrees with.
These folks at the FDA are very bright, cautious and sometimes fastidious if provoked. It is inconceivable that the Agency could now say - "well, we didn't actually get any new information and we really never considered creating a device class for non-thermal, so we are doing nothing." No. They got new science, studied it, agreed with it and now are proposing enlarging their classes to house non-Thermal SWT devices. Asking for comments from the general public is what they do. And that segment is coming to an end on May 21. This proposed change is just another strong sign of the professionalism of the FDA, business as usual. "We now know more than we knew before and propose to make necessary changes to accommodate. I believe we're in pretty good shape, just my thoughts 7up.
You mentioned in an earlier post that you're long at .0032 Josh. Life is such that you can only trust yourself. You can 'respect' posters here, providing there is a long history of credibility, but that is not trust.
You like the potential of BIEL. You are looking to invest more. Anything wrong with averaging down here, and/or lower? May 21 is not far off, tick tock.
You get my point zeek - for around $88K you own approx. 1% of BIEL and it can happen on the almost unsupervised Pinks @ $.0022 while you are sitting on the bid @ $ .0023. Any serious buyer of a large stake in BIEL does it here - wouldn't happen on the OTC:BB
Is there one shred of evidence that a single privately owned entity is not accumulating shares of BIEL? If I, or my company, wished to acquire a significant piece of BIEL by investing a couple of million dollars, I would rather do it down here rather than at the potential price two weeks from now on May 21 when the FDA closes the comment period to its proposal to create a new device space in which BIEL could be housed for OTC approval. Let's face it, <$5Million easily gets you > half the company.
Got it Mary, thanks again. Wanted to confirm you were referring to the apoptosis patent. Tricky developments oncology at the moment, apoptosis versus the creation of a purely necrotic environment, the slash and burn. The former will absorb artifacts remaining, post-treatment, whereas the latter leaves them for future absorption, but often mistaken for new cell proliferation.
At the moment, if one misses with an apoptosis protocol the results can vary from zero effect on one extreme to the stimulation of accelerated cell proliferation on the other. Hopefully a lot of effort, money, trial work and intelligence will advance the theory. Light years away from and behind BIEL.