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Anything is possible and I guess anyone who still owns this stock at least in theory (in the way back recesses of their mind) believes it could possible happen. However given that buy/ask ratio is only 60/40 I would say highly unlikely. Possible someone that sold in December for tax reasons is buying back in after the 30 days wash rule.
So at least another year before FDA approval?
Power - Was looking for something and came across this post of yours from June 2011 :
"Disheartening to see MZEI languishing at 21 cents with very little upward momentum considering all the very positive news that has been released as of this date. "
I could use some "disheartening at 21 cents" just about now!
Today's announcement was good news? What am I not understanding? Sounds like it will be close to 2 months before they even make a decision on how to start the FDA approval ball rolling. While I haven't spent the time to understand all the FDA options it seems like we are far,far away from getting final approval. If I'm understanding this pr wrong please explain it to me.
Isn't it plausible that perhaps the big established players want nothing to do with Medizone and that is why management is left to sign distributor agreements with no name, no sales, no employee companies. Not a very optimistic thought.
Or perhaps we have incompetent management. Not a very optimistic thought.
Or the established companies are requiring very demanding terms for a partnership and management doesn't want to commit to that (yet). A tiny bit more optimistic thought.
Green - Could have been worse - You could have believed the Groundell "commitment" pr and bought at .64 like someone I know :(
So maybe they were/are expecting more news regarding this and are holding off. I'm surprised after 17 years I still have some optimism left!
No additional information on Aglon agreement
Also, on October 30, 2017, the Company issued a press release announcing that the Company had entered into a distribution agreement in the Nordic region with Aglon a/s. A copy of the press release is attached as Exhibit 99.3 to this Current Report on Form 8-K.
I think we could move the needle, but to really make it jump will probably take FDA. Over the past many years we've traded in a .05 to .15 cent range up and down I don't know how many times. So I can see this easily going back to .15 with news of some sales in Europe or SA.
I'm assuming you are referring to 2018, otherwise I think you are being very unrealistic with your time-line.
>> If we can get FDA approval via the 510K process by Thanksgiving or Christmas
3 Days - 3 PRs but no sales. Nice to see they are getting their ducks all lined up, but we are all waiting for the ducks to start moving and quacking.
Sloppy - but no one is perfect.
Has to be a typo.
Maybe I'm a bit jaded, but considering even opportunities that we've heard about from the horses mouth haven't come to fruition - hard to believe the grapevine will produce better results.
Thanks - Not sure I'm reading this correctly but if Medizone classified Asepticsure as a type I then it looks like they didn't need it to be tested by any governmental agency.
"Class I non-sterile, non-measuring devices and general/other IVDs may be self-certified and do not require a CE certificate from a Notified Body."
Either way - my optimistic side is saying this could the precursor to some European news. My other side is saying that this just another pr that isn't about sales.
Not at all familiar with European market/regulations. Is the lack of a CE a barrier to market akin to EPA/FDA approval in US, or is it just a nice marketing tool?
Go - As I said I trusted that David E had done his research, but this adds significantly to my comfort level, knowing they have been working together for several years.
I'm still a bit worried that the ongoing litigation will be a distraction to David D, but I'm hoping a full-time CEO, even distracted, is better than a part-time one :)
Don't resent, but would have preferred someone squeaky clean. I just added some more shares to my position.
>> For those shareholders who resent having a NEW CEO with some baggage as DODD
I'm sure Esposito did his DD, but how can it not be a distraction - at least in the short term?
What can he clear up? He will obviously state he is innocent or that he can't comment on an ongoing legal situation. The real question will be - how is his reputation in the business world affected by this and will it affect Medizone's prospects?
Thanks Eli - I had seen that. I was just commenting on the actual PR which had no mention of his biography and past history. I know when they announce new Board members they usually tout their accomplishments. I would have expected same for new CEO. Hopefully all this will just be noise and we can move on to getting Asepticsure accepted in the medical world.
If this was old news I would be less bothered, but this is something that just happened and is ongoing. Even if the allegations are totally false it will still be a distraction to Medizone.
Go - Strange that there is no biographical information about him the PR.
I vaguely recall mention on the CC of a September European trip for Dr. Shannon. Anybody know any details and if it is still scheduled?
I'm not going to defend Ed (as we are paying dearly for his actions/inactions), but there was a BOD that could/should have provided oversight.
WIV - I can't speak for others, but I bought because we didn't a get a "No". The response seemed to indicate a willingness to move forward so at .07 it seems a worthwhile gamble (not investment) to add some more.
>> I have no idea why the share price rose on this news.
Thanks for the information. However it seems that when dealing with these agencies what they write is not necessarily what happens. We were told to expect a response within 60 days, didn't happen. Real world experience with the FDA (something I fortunately don't have :) ) would probably be more useful in understanding this latest response
Doesn't sound like filing alone will do it - they suggested a meeting. I'm guessing 90 days would be optimistic. With no experience with how the FDA works I have no idea if this is positive or not. Obviously I would have liked a final answer, but I'm hoping that they seem to want to move this forward. I bought more on this news - time will tell if I'm crazy :)
FDA Response
Medizone International prepares plans to submit a marketing application to FDA for use of AsepticSure as a medical device
www.prnewswire.com/news-releases/medizone-international-announces-next-steps-with-fda-on-asepticsure-300509604.html
GreenO - I understood the change in wording very differently. In June, when they thought FDA was close, they said near-term USA and also global markets. Now they are saying Global markets first and secondly they are trying to enter other segments in the USA (excluding medical because they don't have FDA clearance).
Dwayne Montgomery to step down from the Board of Directors of Medizone International
www.medizoneint.com/2017/08/23/medizone-international-announces-a-change-in-the-board-of-directors
Medizone International, Inc. (OTCQB: MZEI) (Kalamazoo, MI) the developer of AsepticSure®, a revolutionary disinfection technology that combines ozone and hydrogen peroxide to achieve unprecedented kill rates of bacteria and viral pathogens in a wide range of commercial applications including healthcare, biodefense, and public health preparedness, announced today that Dwayne Montgomery will be stepping down from his position on the Board of Directors.
Effective August 31, 2017, Dwayne Montgomery will step down from the Board based on some unfortunate medical concerns.
“On behalf of our employees, the board, and shareholders, I want to thank Dwayne for his service and support of the Company,” commented David Esposito, Chairman and Interim CEO. “We wish Dwayne all the best as he prioritizes his health and his family during the time ahead.”
Medizone continues to execute on plans to establish AsepticSure as a superior solution worldwide to achieve unprecedented kill rates of bacteria and viral pathogens in a wide range of commercial applications including healthcare, biodefense, and public health preparedness. The Company continues to support sales and distribution channels in several markets across the globe and is working on entering several segments in the US market.
Go - FDA application was sent in 05/17.
From the CC:
FDA Communications
2.513(g) submission made on May 17, 2017
•Expected response within 60 days
•Highlights from the submission:
•Request for “confirmation that the company’s AsepticSure® (“AsepticSure® System” or the “system”) is not considered a medical device when used for general hospital disinfection purposes, and in addition, is exempt from premarket notification requirements.”
•Rationale for exemption: “Several devices which have been listed with FDA (class I device with pre-market exemptions) make virtually the same claims as the AsepticSure® system.”
3.Hogan LovellsUS LLP is leading the communications with the FDA
BenK - Thanks for clarifying. Good to know that Dr. Shannon is still President of Medizone and that the PR not noting that fact was just an omission.
Exactly. So what do you make of that?
No mention in the PR that he is President of Medizone. Was that an omission or is he out?
Not sure what you are proving? This was an article Medizone submitted. I'm talking about the research being interesting/compelling enough that a third party would report on it. Very different.
(Not to mention this was one article in 7 years)
This has always troubled me. Our medical team is supposed to be comprised of world class/renown experts in their field (I don't mean to cast any aspersions on their credentials). How come during all these years of research they have never been written up by a respected scientific journal or newspaper? I know they are being funded by a penny-stock company and that they might never get to market, but shouldn't the scientific angle have been intriguing to the medical/scientific field to garner some attention? Very puzzling.
That would be nice, but in my mind that is at least a year away.
WIV - According to the cc "material" still counting on private placements so looks like we will have to wait a bit more.