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Allow me to put an unfounded rumor to rest right now. I have visited the company home office in Norcross, Ga. The LuViva system doesn't just exist, but it actually is assembled right there in Norcross. It's an impressive piece of equipment, and we can only hope that Dr. Twigg and his colleagues did some good today.
Sammy...there are new people all over this board. Hype is everywhere. Having attended the shareholder meeting in person earlier this month, I just wanted to reiterate what today's meeting is really suppose to cover. Get it?
Again....today's FED meeting is not designed to get the FED to do a "180" and immediately approve LuViva. Data interpretation has been the issue, and Dr. Twigg and his crew will be working on discussing a more meaningful/relevant manner to interpret said data.
Cool....I have someone new to contact. Keep bringing the journalists on-line to us.
What a boring board this would be if everyone agreed with everything said, BenK. Your commentary sheds some light on areas where shareholders have received little/no updates for a long time. It also raises some new questions. Would there be any new/continuing regulatory requirements for the "new and improved" system?.........for example? History, unfortunately, does not allow me to take anything for granted. Again...I think AS is one of the great inventions to mankind....almost as important as the vaccine for polio. The fact that it is not already on the market is disturbing enough.
It's okay. We're all still dealing with a very delicate and difficult situation. I have met management twice over the years at shareholder meetings. I do not refer to any of them by name on this message board. I do not call them names. I do, however, refer to their historical business acumen, or lack thereof, based on what has transpired since the official creation of AS. That kind of articulate, situation based analysis, without name-calling and/or profanity, has gotten my commentary zapped on this board several times. The standards set by our "moderators" are just a bit awkward. I will ask shareholders again to read the most recent quarterly report and then re-read the terms of the marketing agreement for South America. Does a potential 27 million share dilution get anyone's attention around here? Very few existing shares remain. I will guess that, when the time comes, a dilutive preferred issue will be thrown at shareholders in lieu of a shareholder meeting. Like it or not, management gave away part of the farm and, coincidentally, raised enough cash to get it through the next year and a half. One does wonder what kind of input our two newest board members have had. Just talking business here...........no emotion.
I was agreeing with you that it looks like the company is trying to go it alone.....because any of the big guys would not have hired a start-up. You missed my point.
One would not expect a Fortune 500 company with worldwide distribution channels to engage a start-up venture to begin operations on a continent the size of South America.
Rob Quinn also has been informed about Asepticsure and asked to contact the company directly.
17 Year Man: I like it when a decent article is penned by an articulate journalist with credentials. Sarah Zielinski, according to the net, is an award winning science writer who also has written for Smithsonian magazine. She would be interested in a MRSA eradication process. So, I took the liberty of sending her an email and requested she contact Medizone for more information.
So why don't you contact Rob Quinn, give him Doc Shannon's contact info, and get a story about how Asepticsure can knock out the pathogens.
You all need to read last week's quarterly report.
Cartwright spent 24 years with Abbott Diagnostics and about eight years with GE. He knows that, in order to maintain order within the company and protect shareholders, revenues have to accompany this reverse split at some point. Most penny-stock shell companies that have no serious revenues in their futures see their stocks eventually dwindle down to the pre-reverse split price. Then they have lost 90% of the 10% that remained pre-split (hypothetical). So he does recognize that, to maintain the new NASDAQ listing the company will acquire after the reverse split, revenues are going to have to be there to support the stock price.
I attended the "special meeting" of shareholders at company headquarters yesterday. A total of two shareholders attended: me and a long-time personal friend who is a retired physician in the Atlanta area. We covered several areas of importance with our questions. The new lead reviewer for the FDA is a female OB-GYN. That's good news. We discussed whether or not the company reviews should be under the FDA heading of Diagnostics instead of Medical Devices. The standards set for LuViva under the Medical Device umbrella seem to be ridiculously high...when 95% efficacy rates can be attained with regularity. Questions from the FDA involving true efficacy came up. I commented about the additional efficacy when LuViva actually reverses false HPV readings. So....interpretation of the data is still an issue as is supplying the FDA with new data. The upcoming meeting on Nov. 30 is extremely important, but we can't go to the bank on it. In an ideal world, having two of the lead researchers convince the FDA of the errors of its ways would pave the way for an immediate reversal of the FDA's three PMA denials and give the company full steam ahead rights. That's not going to happen. What we can hope for is that Dr. Twigg and his colleagues can give the FDA a more valid approach to interpreting the data. The business side of things: the reverse split has been approved. Gene Cartwright also reminded us that the business overseas is really starting to show growth prospects. We have to be able to bank on potential revenues from outside the U.S. in the foreseeable future. Approval here in the U.S., excluding some fantastic turn of events after Nov. 30, is still one to two years ahead of us.
Should we assume GTHP knows which companies would get hurt the most if LuViva gains approval? It's kind of the opposite scenario of the murder mystery question "Who Stands To Benefit From His/Her Premature Death"? I have had a couple of suspects in mind for quite some time.
The U. of Miami medical school issued a glowing report on LuViva a couple of years ago. The product has plenty of support within the medical community..... only to be sidelined by bureaucrats with the possibility of hidden agendas......while women fall ill and die.
Never.....the EPA could go in several different directions regarding its decision. Even a troubled U.S. agency should be able to realize the value of AS. How it decides to have the company proceed, however, is anyone's guess. A big problem is that shareholders don't have enough information, and they are not going to be very optimistic given the history of the company. I think AS is one of the great inventions of our time. My beef, as you all know ad nauseum, is that the company basically sat on its hands for three years and did little to promote the efficacy of the system, and its major supporters upheld the inaction. AS could have been tested in progressive countries where improving the healthcare system is a national priority: Turkey, Mexico, Kenya, Costa Rica, etc. etc. etc. Now it's supposedly scrambling to come up with something before the EPA renders some sort of decision. I am done here until the initial verdict arrives. I hope I have the opportunity to say how wrong I have been.
Being only a six hour drive away, I plan to attend the November 11 meeting in Atlanta and will attempt to get to the bottom of it all. Some very tough questions have to be asked, and I plan to ask them.
Penny stock companies rarely produce a product as important as AS. Most of the time they're just shell games. All won't be lost if the EPA doesn't give a "carte blanche" approval right out of the chute. What do you all think? Should we expect the EPA to give us a "thumbs up" without the first U.S. test being completed? I really hope I'm wrong.
Rotary came to mind because it is one of the very few organizations to have global infrastructure already set up through its network of clubs in over 200 countries. Few products have the potential to save lives as AS.
So far, 60+ polio aids workers have been murdered by the radical Taliban in Afghanistan and Pakistan because of the fear that infidels were either trying to sterilize or kill their children. Those two countries, by the way, are the only two left on the planet that have had new cases of polio in the last twelve months. Is Asepticsure any less important to a person who eventually will die from an HAI? We can thank Rotary International, a global service organization created in Chicago in 1905 and now managing humanitarian projects in over 200 countries, for taking on the job of world polio eradication in 1985. Gee......maybe Medizone management should contact The Rotary Foundation and let it know about Asepticsure. Well, TRF should have been contacted five years ago....but.....we know how things are. The world was supposed to have made a bee-line to Medizone.
In 1955, Dr. Jonas Salk had his intravenous polio vaccine approved by the FEDS. Dr. Albert Sabin, eight years older and a WW2 vet, was late getting clinical trials started because of the War. Politics within the medical community forced Dr. Sabin to terminate all new testing in the U.S. So....while Nikita Kruschev was beating the bottom of his shoe on the podium at the U.N., telling everyone he was going to bury us, guess what Dr. Sabin was doing? He and a team of Russian virologists had created 100 million doses of the oral polio vaccine, manually created a map for a distribution program, and proceeded to vaccinate everyone in Russia, Japan, Holland, Singapore, Mexico, and half of eastern Europe. Good science and good scientists trump laziness and bad politics. When the Cutter incident happened in California, a contamination sequence with the Salk vaccine that killed and paralyzed many children, the FED apologized to Albert and asked him to restart trials in 1960. The rest, as they say, is history. Medizone has none of the roadblocks Doc Sabin had. I guess I am going to wonder what the attitude of the shareholders will be if the EPA says it wants more test results. Are the largest shareholders still going to be complacent and maintain the status quo? If so, I think a derivative grievance would be quite possible.
No apologies, but I can't let jackross18's commentary smolder without a comment. Think about it. The only entity capable, because of the amount of stock it supposedly holds, to bring accountability to Medizone over the last five years, has been whatever it is this Florida Group is supposed to be. Allowing management to continue failed policies, however, makes the FG an enabler and nothing more. Much time has passed since the two white knights were brought on board. Esposito bolted to run another company months ago. How much time and effort do you all think he is putting into Medizone right now? Can Caponi do anything but sit on his hands at the juncture? Balzer, the distribution whiz kid, must be pulling his hair out. Yes, some type of demo/test is, after two years, finally going to begin in Canada. What else is going on throughout the world except more hand sitting on testing and more hand wringing over the EPA? No one should be surprised if the EPA says it wants more testing to be done first. A company can't be sold when no one knows what it's worth. Can't management and the Board envision how wealthy it might become if AS was successful? Dr. Albert Sabin must be turning over in his grave.
The big thing over the last 24 months has been the company's inactivity in the area of real trials after the company acknowledged that these trials needed to be done and would be forthcoming. Permission often has to be granted to conduct those trials. I am sure you all are tired of hearing from me in general and are really tired of hearing from me in the area of organized real-world testing. Sorry.....I'm 98% business and 2% emotion. It's a travesty to have such a game-changing technology stuck in the hands of inexperienced people.
Like you, I often have pondered why our FDA has turned down LuViva three times. Reviewers, we have to think, get reassigned here and there over time. There could be a lot of reasons why GTHP has been assigned a new reviewer. One of those reasons, however, could have to do with the lack of impartiality of the reviewer.....for whatever reason.....and the company took it high enough to get said person replaced. If the test works as well as GTHP and obviously its foreign customers say it works, then we really have to scratch our heads. The company has NOT been willing to give specifics on why it was turned down. Maybe it didn't want to tick off anyone else at the agency. That part has always bugged me. Today is it's special meeting of shareholders. I am out of town on business or would have made the five hour drive to Atlanta to attend. I wanted to ask that very question: Why really has it been turned down? If it was my company and truly worked this well, I would have sued the FDA a long time ago. The bottom line is that a new reviewer is really good news. The company was getting nowhere with the old reviewer.
My recollections tell me the FDA declared Asepticsure a Class 1 medical device, washed its hands of it, and passed along the regulatory scrutiny to the EPA.
The multi-month delays of testing in Alberta are ridiculous given Canadian approval and the supposed rising support of its healthcare bureaucracy. Asepticsure systems can be sold there...but they aren't being sold there. Why not? The two sales (are they final sales?) to KSA will help as long as 1. the first ever sovereighn business plan gets developed and results in sales in the hundreds and 2. positive test results can be obtained and brought back to Canada to show Canadians that AS really should be tested in the first country to give it approval.
Hi Joe......mergers and buyouts usually take three forms: all cash, all stock, a combination of both...and once in a while some debt as well. The only time we see the stock of the company being acquired rise to the actual agreed price level of the buyout is during an all cash deal. You always will have an opportunity to sell your stock in the marketplace before it is redeemed via the merger. Regulations have to be met, and shareholders vote on both ends. Once in a while mergers do fall through, so selling your stock while it is "up" costs you a little bit of money but protects the buyout price.
One of the ongoing problems within this tiny company has been its inability to research, identify, and plan market penetration.
A couple of conspiracy theories have entered my mind over time. Maybe someone at GTHP, a few years ago, ticked off someone at the FDA. Maybe the big buddies of the FDA, big pharma, have expressed concern over the possible loss of pap smear and biopsy revenue. One never knows.
The company tells us that efficacy rates are in the 99% area, yet the FDA has seen fit to reject this thing three times. It all doesn't add up, does it. I read the company's text on its meeting with the FDA and what was required. These guidelines are basic testing protocols that should have been enacted by GTHP three years ago. Is the company so incompetent that it can't follow some basic instructions? Is it's efficacy rate really questionable? Obviously there are major issues with the interpretations of the test data, yet the company continues to be vague in its explanation to shareholders. It's getting a bit tiring at this point, and I am not surprised that some rather large shareholders have bailed. Possible approval is now yet another year away.
BenK....I reiterate that the developing world, with a little proof of efficacy, will not wait on a U.S. regulatory body when a treatment is proven to save lives and reduce illnesses. Other companies are being proactive as they wait on the "dinosaur" to render a decision. Medizone can do this...but there obviously is no game plan. I'm just scratching my head wondering if our two newest Board members should find suitable replacements for themselves who really give a damn and could become actual employees with responsibility for corporate governance and global marketing.
A new MERS outbreak in one of Saudi Arabia's largest hospitals has been reported.
We have to come to grips with the fact that there is no sales force infrastructure, no capital, no depth of resources to capitalize on EPA approval in place.......never has been. The only logical positive outcome for this situation is a buyout upon EPA approval. I have my own doubts, however, the company can get approval, right now, given its lack of real-world testing. It has had 3+ years to conduct serious work-place tests. A buyout would be the only way management and this board could retrieve some semblance of competency. We also should be reminded that any buyout would have been created by our two newest board members. A potential buyout is THE only reason why maintenance of the status quo would be tolerated going forward.
Management is aware of its shortage of remaining authorized shares. Looking back at the last several 10Qs, we continue to see content filled with internal perks and nearly void in the area of activity leading to sales of AS. Has the company furnished enough real-world test results to the EPA to garner an approval? History says "No". No sales in Canada and a foot dragging EPA mean available shares are gone in a year. I believe the company will try to sell a preferred offering in an effort to recapitalize. Principal and dividends would be dilutive. We should demand that NO ONE commits to buy any private placement until a shareholder meeting is held. Maintaining the status quo, in this environment, should mean only one thing: the company is SOLD upon EPA approval. Accountability is in; playing kick the can is out.
So....it looked, talked, and walked like a duck and cost shareholders another 50k in dilution.
Medizone certainly cannot afford to waste any more time and opportunities. Think to the patent clock. This company, given its snail pace history, could take another 2-3 years to complete adequate real-world testing and generate the first few sales off that testing. Shareholders do NOT have that much time. Get the EPA done and SELL this baby......don't give it away.
This information is now a year old, and one must assume the results were included in the submissions to the FDA. It still doesn't add up why this product is not on the market in the U.S. The article mentions the savings to the healthcare system, but it doesn't mention the hit to the big boys involved with the Pap test and biopsy business.
If it looks like a duck, walks like a duck, etc. etc. etc. It looks like a one million share PPL bought at a nickel the day before the 2nd most important announcement in the history of Medizone is made. A PPL bought one day later off a .14 stock price might have commanded a dime instead of a nickel. What I see is an additional 50 grand dilution to shareholders.
add another zero after each number
that's what we're supposed to do, Spumoni....go home and enjoy the weekend and not even think about Esposito securing a PPL for a nickel the day before Shannon's press release hit.