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And I'm thrilled about that. What you're saying is, the guy who is dealing directly with the FDA is certain that approval is coming... it's only a matter of when. Isn't that great news?
A categorigal statement is one in which the parameters are defined in concise terms. For example, when Bigbreak said that we would be at .26 yesterday, that was a categorical statement. It was a single 24-hour window and a specific PPS value. It was also categorical when Bigbreak said we would have FDA approval by 8 PM tonight. A specific time period was identified. Saying something will happen "soon" or it will "fly through" or it's "any day now" or "it's a matter of when not if" are, by definition, NOT CATEGORICAL. What is the specific definitive time period that you think Dean meant when he said "fly through"? That is exactly the opposite of a categorical statement.
I'm sorry, what is categorical about "fly through"? I looked in every dictionary I could find, and I could not find anything that defined "fly through" to equal 30 days. You do know what categorical means, right?
A miracle they've managed to keep the lights on despite your warnings about this since I first looked at this Board nearly a year ago. Yawn.
Talk about rank speculation. I think, I don't know, but I think you have absolutely no basis for that. I think the the "personal loan" was related to Dean continuing to personally finance the Company to ensure its stability while we wait for FDA approval. I think that, and I've got as much support for my speculation as you do.
Doesn't it mean that he transferred 2.8 million shares for the repayment of a $1.86 million debt? Seems like a pretty good deal for Dean, to me. Not sure why you keep saying $180,000.00, when Kimble just posted that it was $1,858,714.
Link, please.
Please post a link to the images created by a single device on the Medtronic or GE websites from a device that does not currently have FDA approval. I appreciate your due diliegence here.
You must be mistaken. BigBreak said we would be at .26, and he is 100% right, 100% of the time. Go back and check again.
Look at the video. It's obviously not being recorded by a video camera. It's obviously a digital file. How else would it get there?
Did you look at the hand spliced in at the end of part 2 of the video tour? That is a better quality image than you are going to find on the internet of already approved devices. All of my radiologist friends agree, that, upon seeing that image, we have a gold mine on our hands.
LOL. Because I clicked on the link on the top of this screen, on this message board, skipped ahead to the end of the video and wrote down the start time and end time of the spliced rotating hand, I must be working for somebody? One of the strangest things I've read here.
I receive no income, no payment, no benefits, no party favors, no nothing for anything that I do related to Imaging3 from any source whatsoever.
I have made, what I personally consider to be a substantial personal investement in Imaging3 based on my own due diligence. I have also persuaded many friends and my entire family to invest here as well. It is for those reasons alone that I continue to do as thorough due diligence as I can, rebuff all the nonsense that I read on here. Somebody on here today said it correctly (when they were trying to insult me), I am just trying to protect my own investment. When I see lies being spread about the Company, I point them out as lies, to protect the investment that my friends, my family and I made. When I see someone misinterpret FDA practice or procedure, I correct it, to protect the investment that my friends, my family and I made in Imaging3. That is all. There is no point in further disecting this. I have absolutely 0 interest in Imaging3 or the people involved in Imaging3 other than the stock that I purchased, and the stock that was purchased by my friends and family. I would appreciate if you could all leave the personal attacks and slander out of this, and just provide some facts about the Company if you have them.
My radiologist friends disagree... especially the rotating hand at 4:33 - 5:19 of part 2 of the video tour. That one that is not video recorded, but actually spliced in at the end. They think it is very useful. What are you medical credentials, again?
Do 10 seconds of your own due diligence for once. I told you where to find them all. Look in the iBox on this site. Look on Imaging3's website, including the very end of Part 2 of the video tour. Look at the video linked at the yellow tabs of this page. Search my post history, I've actually linked a bunch of them a bunch of times, including a bunch of times in response to you making this exact same claim.
First of all, it's 3 years not 4. Second, if you did not think the last MoneyTV spot (really the second to last) included detail about his interactions with the FDA reviewer, then you really don't pay any attention to what he says. He spoke volumes about the type of interaction he's having with the Reviewer, and that was less than a month ago. It was also 100% consistent with what he has said every time before that about his interaction with this very Reviewer, on video updates, other MoneyTV spots and every other time he has spoken publicly about the FDA process. Pay attention to what he says.
I do not work for Imaging3, either officially or unofficially. I draw no income from Imaging3, either directly or indirectly. I am just an investor who is able to string together coherent thoughts in written form.
I am not related to Dean, nor do I have any personal relationship with Dean whatsoever. For that matter, I have never even met Dean in person. By no means do I get regular updates from Dean about anything.
It's all out there for public consumption, Kimble. If instead of just making fun of his tie, making jokes about waiting for the cell phone to ring, mocking the camera work on in-house videos, remarking about who he is sitting next to or working with on other business, or twisting and contorting what he says about the status of the FDA process, you actually listened to what Dean says when he speak publicly, you would already know everything I ever post about Imaging3.
I don't answer to you, and I don't need to anything for you ASAP. All you have to do is open your ears, listen to the conference calls, listen to the video updates, listen to the MoneyTV bits, open your eyes and read things that Dean or Mike writes, read official filings and correspondence, and open your mouth and ask reasonable grown-up questions to management representatives at Imaging3 and you will know as much as I do about this particular company. After that, go to law school and practice in the regulatory field for 12 years and then you will know as much as I do about the FDA and agency proceedings. It's out there for public consumption, Bog. All you have to do is stop complaining and start listening.
And apparently you didn't mean .10 either.
Ounce, Dean has way more regular, more substantive, and more personal communications with the reviewer than the every 30 days by fax provided for by the Status Program at the FDA. Take a look at what you listed as the information that the Status Program provides for:
"* The ODE or OIVD division or branch to which the 510(k) is assigned;"
Dean knows exactly to which division the application is assigned. In fact, he has regular communications with the actual reviewer. What is a fax every 30 days identifying the division to which the application is assigned going to tell him that he doesn't already know?
"* The last action, and date of action, that ODE or OIVD has taken regarding the 510(k);"
If he talks to the reviewer as often as he does, and he knows the application is still under review, what is a fax every 30-days that says: "application assigned to reviewer and under review" going to reveal that he doesn't already know?
"* The position of the 510(k) in the reviewer's queue;"
He knows where it is in the queue... it's at the top because it is currently under review. He knows because he speaks regularly and openly with the reviewer, so what's to be gained by a fax every 30 days that says: "application assigned to reviewer and under review"
"* The average review time for the division or branch."
These statistics are publicly available. What's to be gained by having the same set of statistics faxed to him every month?
It would be one thing if Dean was sitting there in the dark and the application was sitting in a black hole, but the reality is, he is getting regular updates. He knows exactly where things stand. He talks to the reviewer regularly. The Status Program is not designed to provide any meaningful substantive information. It exists for entities who have heard nothing from the agency and just want to know if there application is off the shelf yet. We know ours is on the reviewer's desk and Dean knows all of the information that the 30-day fax would provide. So what would be the point of it?
I understand your frustration, and what you're really saying, and I agree... we, i.e., the investors here, would like to get some sort of official update every 30 days. But this is not a public process and it shouldn't be. As much as I'd like to be a fly on the wall during Dean's regular communications with the FDA reviewer, that's not the way the process works. But to suggest that Dean is sitting there in the dark, not taking advantage of some "valuable" tool to gauge the status of the DViS application is just not accurate. The tool is hardly valuable because the information that the FDA provides in response is very basic and largely generic, and Dean already knows all that information and more. It's just that you and I don't know it, and while that is frustrating, it's just something we have to deal with. I wish I knew exactly how Merck's latest dealings with the FDA were going in their latest cancer treatment, but they don't reveal that to anybody. We just have to trust that they're doing everything they can to get the job done... and with his own personal 60 million shares, and the millions of shares that he's got his friends and family in for, I have little doubt he is working as hard as he can to make this happen.
FDA approval, in and of itself, is not a magic gold mine. It all depends on the individual product that is being approved. The idea is not that FDA approval equals massive value, it's that the ability to market and sell this particular medical device, which you cannot do without FDA approval, equals massive value. Likewise, the value of the Company with a patent on this breakthrough product that is approved for marketing by the FDA is worth a massive value to GE, Toshiba and other major players in the industry. We'll see an astronomical jump in PPS when we get the approval for this device. Right after we get it, I wouldn't be surprised to see Dean file several other 510(k)'s for add-ons or other intended uses for this same device. The subsequent approvals associated with those applications will not generate the same increase in PPS because they would only add an incremental value to the device that would already be flooding the market. So not every FDA approval has the same impact. I hope that answers your question. What's the other stock you were referring to?
What is there to update? They have done them so they can effect the most critical communication in the history of the Company without any scrutiny by the SEC. They have done them because they KNOW the good knows will come and they don't want to be caught unprepared. It's a good sign and you can laugh all you want.
Look, I don't disagree with you, but we're talking about two different things. What you and I are talking about right now is the spike that comes right before the approval is announced because information leaks out from somewhere, the FDA, the Company, the Company's SEC lawyer, etc. Who knows. What Shaka and others keep saying is that approval must not be coming soon because the PPS is still flat and relatively low. My point is that you cannot infer anything at all about the timing of FDA approval from where the PPS is floating around because there are only two people that know when the decision from the FDA is coming... and that's the reviewer and the head of the CDRH. I would be thrilled to see a massive spike on massive volume because that may well be a sign that the cat is out of the bag... but it will be pretty much too late at that point.
If that sort of thing goes on, I don't know anything about it, but regardless, what you're talking about is the few hours right before the approval is announced, not the PPS trend in the month or few weeks before approval. Shaka is suggesting that since the PPS has been lingering around .30 for a few weeks, that approval cannot truly be imminent. I suggest that one has nothing to do with the other. Now there may well be a spike in the hour or so before the approval is announced, but who's to say that is not an hour and 10 minutes from now? My point is, the current PPS, where it has been for the last several weeks, reflects no knowledge by anyone as to when approval will come, and it cannot, unless Jeff Shuren and the reviewer himself are leaking information, and I am sure that is not happening.
Shaka, explain to me how the share price and the timing of approval are linked? Do you think the FDA reviewer and the director of the CDRH are going to buy millions of shares right before they approve the device, thereby driving up the PPS? Do you think they are going to leak that they are about to approve the device, resulting in a spike in PPS? Just how exactly will the market reflect that the device is about to be approved, considering that only two people (Jeff Shuren and the reviewer) know when that is going to happen?
The problem with that analysis is that NSE is not just about being different, it's about being different in a way that neagtively affects safety. By it's very nature, a software change, especially one that is essentially different in that it performs the same task as other devices only quicker, does not negatively affect the safety of the device. In fact, it makes it safer, not less safe, because it's what allows the DViS to expose patients to even less radiation than the predicate devices.
It is an extraordinary circumstance that a software improvement results in an NSE determination. Truly extraordinary. In fact, I challenge anyone to find an NSE determination where the only difference is a software change resulting in faster performance. I will eat my words and apologize if anybody can present a link to proof of an FDA NSE determination for an upgraded software that resulted in faster processing of the same function already approved by the FDA. You will not find it.
Can't say I agree with you there, Chemic. He's been calling for a dime since he's started posting on this Board, and we're not even close. If you believe that being off by 300% is close to the "truth," then I guess I understand the rest of your posts now.
You were telling people to sell from the .60s down to the .20s and when you weren't directly tellling people to sell, you've been trying to scare them into selling throughout.
Oh, and by the way, you just described, by definition, what a specious argument. You said X, PPS went down, so you are responsible for people losing money. That's like saying, Since we have this rock in the front yard, we haven't had a tiger attack, so the rock must be what keeps tigers away. Courtesy of Lisa Simpson.
I have analyzed FDA regs and expressed my believe in Imaging3 and its CEO. The PPS went down. I'm responsible for that? Get a clue.
If he wanted to hold the CEO of the company accountable, he certainly has that right. But you realize, I'm not the CEO of the company, right?
If only it were up to me. I would be honored to be formally associated with this Company and its CEO.
You may be confusing him with Bogdan. When said I'd take Bogdan's absurd prediction, he said "name it," and did, and then he ran for the hills. BigBreak just ran for the hills as soon as he was called out.
He has said, specifically, he can NOT sell the DViS without meeting certain criteria, i.e., similar regulatory approvals, requirements to have major maintenance forces set up in the territories where it's sold, enhanced risk of theft of intellectual property overseas, etc.
If you get U.S. FDA approval, you get rubber stamped by overseas regulators, but not vice versa. It is the right move to play it out in the U.S., get the FDA approval and then push to the full international market at that time. The U.S. Market is by far the largest in the world, and you don't want to risk compromising your intellectual property before establishing a strong foothold in this largest market in the world. It's a business no brainer.
We've heard you BigBreak. We've heard you say it was going to hit .10 for about as long as everybody here has heard me say there's a good chance we get Approval this week. A lot of people asked you to put your money where your mouth is, and you ran for the hills. If you really believe it's going to .10, stand by that prediction. I'll take that bet any time you want. Otherwise, everyone here will know that you don't really believe it's going to .10, you're just trying to scare people into selling. It's not working, it's not going to .10, and everybody can see right through you. If you're going to make absurd predictions, at least be a man about it.
Is that until it hits .24, at which time you'll say, oh earlier I cancelled that order and changed it to .15?
I can't believe that I'm seeing actual useful DD on this Board again. What a relief!
That slide show and this re-post from Yahoo are the two best bits of DD I've seen here in ages. Thanks guys. Let's take this Board back from the non-sense that it was becoming and make it useful again. Keep it coming.
Great stuff. Where did this come from? Do you know who the Dr. is that is named on the cover as the author of the report?
Of course I do. It's a public report on the status of the FDA process. I know it's fun for you to make fun of the waiting for the phone to ring bit, but of course he didn't say that, but instead, offered a substantive recap of where things stand right now. Not sure what else you want to hear from him.
Let's see, in the 7 weeks since June 10th, Dean has done 2 video appearances. That averages out to about 1 every 3 weeks doesn't it Bog?
Perhaps you should look up the distinction between a prediction and a statement of fact. I have a $20 bill in my pocket. I expect that I will win $20 from the lottery ticket in my pocket. One of them is a statement of fact known by the speaker to either be true or false when he says it. One is a prediction that cannot be known with any certainty. Let me know what your dictionary says.
Dean has gone under oath and sworn that he has a working product. Do you understand what it means to be a CEO of a publicly traded company? When a CEO of a publicly traded company makes a material public statement either in writing or on a conference call or a television program, that is swearing to the SEC that the statement is true. Any knowing false material statement to the public by an officer or director of a publicly traded company is a prosecutable crime... so every time Dean speaks, he takes the oath, and Dean has spoken many times about having a fully functional live time 3D imaging device. There's the oath you're looking for. Can we move on now?