Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
gdsgds was the last person to visit I3 and he did so on Wednesday May 19, 2010, two days before Mr. Janes' FB post. Check post #16243 by gdsgds and you'll see why I don't think this is about a video of 3D images.
You can't say you're going to film a video, release a newsletter and have a press release in the near future?
That's the hope. That's what's pending. That's what we're all waiting for. Its been so long a wait that I think people find it hard to believe we're finally here.
IGorB, you're very much on top of this process. If I recall correctly, Mr. Janes was reluctant to show more images in the past for the very reason that doing so before FDA approval presents a problem with respect to the ultimate goal of obtain approval. Why would he suddenly show images before approval now?
I don't think it was the, "image controversy," that brought the stock price down. I think it was the delay in approval. Are we in agreement that the stock rose sharply on anticipation of approval last time and began to fall sharply after the delay was announced?
What has everyone, including Mr. Janes, been on pins and needles about for the past 2 - 6 weeks or more? Anything else than what we're all truly waiting for is indirect pumping for temporary gain IMO. Okay, he shows 3D images for public display. Even if they're the best images the world has ever known, investors will begin to speculate on some other possible negative to explain why the process is dragging out. How long has that 3D image of the hand been on the I3 website now, anyway? And the longer it drags out the more likely history is to repeat itself in terms of the PPS over the past few weeks/months.
The posting on FB put the stock in hyper-drive for the day. If this upcoming news is anything less than the bottom line, I don't think this stock will move much more until the bottom line finally comes. Let's not get distracted. The public display of images is not the bottom line here.
A.P.R. "Imaging 3 is please to announce the public display of 3D images taken with its revolutionary device the Dvis."
Please! How disappointing would that be for anticipating shareholders? If publicly displaying images is what this is about I suggest they keep it and put the money it cost to do that to better use. I don't care how little it may costs to do a PR, video and newsletter. The last 10-Q suggests splurging on those things to hype anything other than approval isn't really in the company's best interest right now.
Absolutely correct ack0605. If anything, now's the time to really load up. I just added at .36 and I'm glad I was able to do so before Monday a.m.
EXACTLY!!! How crazy is that? Not just Mr. Janes but the entire management team is going to go along with an ongoing false claim about the Dominion's capabilities?! "Oh it can't really produce 3D images but we're going to say it can and hope we never get caught." And they're going to try to run that lie past the FDA?! The FDA who ultimately decides whether or not the device ever sees the light of day? That's just absurd.
Today was an ugly, screwball of a pitch on very good volume. I'm not sure what that means but don't think it will go below .30. It might touch .30 at some point though and if it does, I'm loading up again. This thing is a go and we're very close now. But what's with the sudden volume on yet another down day? Shaking out the weak? Big move by the powers that be to seriously suppress the price before approval and the subsequent bidding war? Anybody seen this situation before and can explain it?
E all the way. Would like to buy more before the eruption, tho.
Thank U IMGorB for saying what I've been thinking all day. Some added legaleeze gets thrown into a 10Q and suddenly the end of the world is at hand. So ridiculous that it actually became comical at one point. Boy, the tension on this board today was like being in preschool during a full moon. Come on FDA approval, 'cause we're going nuts here. No offense to anyone in particular.
Here's the answer to part of your question that states, "They agree on a price per share to buy it at and thats the final return us shareholders receive?"
Answer: This will be the PPS at which I3 is bought out. Let's say, for example, the company that wins a bidding war agrees to pay $5/share for the I3 in a buyout (Just an arbitrary number. I'm not saying this will be the buyout price). If that is the case, the pps of the stock on the market should immediately head toward and settle at or very, very near $5/share. Why, because if the pps is below $5/share at the time of the buyout, people will want to buy in at that lower price knowing that the buying company will contact them with an offer to buy their shares at $5/share (they'll make more of a profit).
On the other hand (this part is an unlikely and nearly impossible scenario) if the pps on the market at the time of the announced buyout price is above $5/share, people will immediately sell stock until the pps on the market matches the buyout price so they can keep the extra profit they have because the market price is currently higher than the buyout price.
Finally when the deal's all done the buying company will send out a mailing to all shareholders offering buy all shares of the company for $5/share. Because the market will adjust the price of the stock once the agreement is finalized in writing, you can sell your stock before you get the letter or wait and sell directly to the buying company. The letter may come to you in a week or in a month etc..., depending on the efficiency of the buying company, the number of letters needed to be mailed and so on.
Exactly one week ago you said something very different. What has changed? See post #14468
Thanks Maddog. It sounds like one of the posters on this board was right when he said the thinks the FDA team is having some difficulty understanding the device. Still, I don't think a PMA is anywhere near appropriate in this case. With quality images and a good safety profile we should be in the clear here.
I am a doctor but I'm not a radiologist. And outside of trained radiologists, most of us aren't qualified to judge more complex radiological images anyway. Though I can read x-rays, I can't read them as well as a radiologist who has completed a residency in radiology. I'm even worse at reading CAT scan images and don't even put me in the medical-legal trap of asking me to read a HIDA scan or something like that. A wise physician always calls the radiologist for a second opinion when viewing imagery with which he lacks sufficient experience. I could have been there in your place and probably would have gotten out of the experience a bit more than you did, but not enough to give a qualified opinion to members of this message board. So when people complain that you didn't see the quality of the 3D images, I don't know if they're even taking into account what it really meant when you made the disclaimer of, "I'm not a doctor...." What you were saying was that, like me, you lack the training to give an expert opinion (even if you had seen some 3D images).
So I say thanks for going and, especially, thanks for sharing with the rest of us. Anyone who wonders if the 3D images exist needs to go to the I3 website and look at the homepage.
Doc
You're welcome, bcatch. To have falsely posted that you saw the device etc...would have been doing a disservice to yourself was my thought on the matter. I do like to verify info when I can, tho. So I was actually questioning how the verification of your visit was being stated as fact. One tends to see a lot of posts being stated as verified fact and the more of those I see the more skeptical I tend to become. No offense to anyone.
I believe bcatch's meeting took place and that his report of what he saw is honest and accurate, but who confirmed it? Sorry, I must have missed that post.
I doubt that will happen in this case. Selling on the news occurs when there's been a run up in the pps due to pending news. That hasn't happened here so there is no profit to take.
Excellent point, D.
Alright. I'm confident in this company and its premier device and I have been since I initially bought in at $0.22 about a year ago. I'm with the stock and the company for the long term (even after approval because I expect the positive results to continue until the final stage, whether that be long term production or buyout). The longs here who seem to be playing devil's advocate have a right to their opinions and more importantly have a right to keep the company brass' feet to the fire as shareholders. But let's face it longs, Mr. Janes was right when he said, "its not a matter of if but when." (I'm paraphrasing)
Our concern here has to do with the length of the process. It's taken far too long and maybe justifiably so given the unique nature of the product. And when we hear in the latest video even more info had to be submitted, it just adds to the jittery fire. But who among us longs who has truly done his/her most diligent of due diligence is willing to miss out on this opportunity based on speculative pre-approval fear?
Bottom line: 1) Do your DD to the best of your ability and then believe in it. 2) Don't risk anymore than U can afford to lose. And 3) If you can't stomach stocks then you need to be investing in something else like mutual funds, CD's, etc...
Long and Strong. See you shortly in the WC and GLTA;
Doc
LOL!!! I knew there was yet another reason why I'm an investor in this company.
True. There is no concern on my part, whatsoever, about the integrity of I3 or it's CEO. I respectfully refer to this CEO as Mister Janes purposefully and for very good reason. Any concern I have involves the bureaucracy which which Mr. Dean is interacting.
Of course, we're all speculating here. Yes he said past tense but that could have been last Thursday.
Right. Asking for the info during the existing time frame is a part of being on the fast track. But the FDA doesn't HAVE TO get back to the company with an answer in 30 days, it will only do its best.
Is it the "supplemental" info Mr. Janes said he sent that has you worried? I personally thing a PMA would be ridiculous in this case and I'm convinced that the 510k is teh right application under which this device should be filed. But the "supplemental" statement stood out in my mind as more info that would take more time for the FDA to examine. Hopefully I'm just being paranoid and this is just the FDA being thorough, hopefully in a timely manner.
Still, I don't think he was answering those questions off the top of his head. And if he was answering those questions without putting a great deal of thought into them, one would think that any confusion created from the last time would cause him to be more cautious well ahead of time this go round.
One would think that any confusion created from a hastily produced video in the past would be safeguarded against well before the last minute shooting of the upcoming video. Any confusion created before was due to video content. Mr. Janes and his team have had plenty of time to scrutinize questions from the forum and carefully craft accurate responses to those questions. I'm not sure a delay in this video has anything to do with what's written on the sheets of paper he's reading from. Unless, however, something(s) major have/has changed at the last minute that requires editing of content instead of physical editing of the video itself.
Have the forum questions section been cleared? I don't spent much time on the investor forum, but it looks like the forum's question section has been cleared. Can anyone confirm who spends more time on the investor forum page confirm this?
These may help answer your question at least to some extent.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
So are you saying in this scenario that the PR would come out before the video?
I don't think we'll see a video come online today either. If they decided to take off Saturday (which is fine), what would be their reasoning for coming in on Sunday? Perhaps performing other work related tasks at home?
Yep, you're exactly right. I experienced the samething with DNDN when their Provenge phase III results were revealed. Luckily I used a mental stop and the pps blew through it so quickly I didn't have time to sell so I held my shares and watched the price bounce right back and then some in the after hours. The message boards went crazy, though, with all the people crying about getting their stops taken out and losing tons of money.
I played that exact scenario out in my head several hours ago.
Yet another FDA approval yesterday. There have been a string of FDA approvals over the past few weeks. Check you the latest quote and news for POZN. Though its a drug approval, my hope is that this recent FDA trend signals upcoming good news for I3.
Okay. Makes perfect sense to me now. For some reason I had it in my head that the new team came on Dean's announcement and not before. But in hindsight they had to have come on well before the CC and would have had to have taken the time to review the application from scratch, thus the 18 questions, etc. And now I do remember some mention of the FDA apologizing for their lack of timeliness. Thanks.
I don't remember getting any explanation as to why the team was changed out for a new one. I do remember that Mr. Janes seemed pretty frustrated by the whole process during that CC. Anyone have an exerpt from a transcript, a quote from an audiotape..., anything?
I pray this logic is sound and that the inevitable is at hand. I'm long and have been in for just over a year. So someone tell me I'm wrong about this. Didn't the last request for more info occur beyond the 14 days you just mentioned and if so, we're there special circumstances as to why?
Thanks BamaStang.
KF, the bottom line is that you are correct when it comes to the bottom line. These radiologist certainly have something to lose if they blindly give this or any device a pass, just as they have something to lose if they wrongly reject a quality product. For that reason, you're right, they're very likely to give their most honest opinions.
Not quite how the radiologist profession works, Kingfisher. Radiologists are medical doctors (M.D. or D.O). As such, they follow the rules of all medical doctors. They get board certified every so many years, usually seven years at a time, only after re-taking their board exams. All docs are required to re-take their boards every so many years if they want to remain board certified. Not all doctors are board certified, though most hospitals or other kinds of employers (large group practices, HMO's, etc...) prefer it. A doctor can continue to work, however, without board certification.
When it comes to publicly stating a medical opinion, whether it be about the efficacy of a given drug or the quality of radiological images, very rarely is your job at stake and never is your certification at stake. The only thing these radiologists are putting at risk are their reputations and their credibility. For a doctor though, even putting these things at risk is more than enough incentive to get it right.
Doc