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Surely one of you must have the balls to call, why don’t you IMGGORBUST? I have been talking to them for about a year-nice people very friendly, I wish I would not have burned my bridges but-oh well.
Because I know Mike would not talk to me after posting info that he gave me to benefit people like you, that he did not want me to post.
I just called Becky and she said she did not know Mike Nessens schedule today. I would suggest calling I3 @ (800) 900-9729 and ask for Mike Nessen to confirm if he has an appointment to show the DVIS today. at 1 pm
my bad, EST here
shouldn't you be on your way to Imaging3?
Great post Fink, I agree that the market should decide if it is junk or not. I can see FDA having concerns over vibration or something of that nature, perhaps that was what the Radiologists review was all about. I think we have jumped through too many hoops thus far for it to get denied-FDA is so political though, Who knows? The reviewer does.
lol wonder what the predicate device was he compared it to? I bet he put it through more stringent testing then the Dominion!
I have to say I agree with you, Dean IS the type that would like to see the shorts flee. He is a very confident man and I really hope he comes through. “HOWEVER,” I got privy to some info that led me to believe some issues remain. If he wants to keep sugar coating and beat around the bush then its down down down from here. ITS TIME for him to answer the tough questions. They had issues and he needs to address them. I have some questions I am sending to Dean/Mike that I feel deserve an answer. they are;
What specifically did the FDA have questions about in their last response to you?
Can the DVIS “currently” produce the high rez images without any crashes or issues?
Is the DVIS “right now” perfected to the point that it is ready to be used reliably in a hospital?
Do you feel that Political forces are at play here? If so, many people will stay invested because they will know you have a working product that will “some day” get approved.
anyone have more? If he can say yes to these then based on all the good this product brings to market the pps should go up and eventually get approved.
Pepa I DID pose these concerns to them many times and felt making them public would convince them to respond. My apologies if I scared anyone. There is Integrity about me and I felt the info needed to be shared. As I said I have a problem with Dean asking people for more money when people like you have so much at stake-its just not ethical. I am going to post on I3s’ forum and hope he can clear things up in his next release.
you probably got lost in my junk mail as I had about 100 people email me and I started losing track. email me at cmossor@neo.rr.com and I will send it to you. please include your ihub name
Thank you for your comment investor trader
Look I am HEAVILY invested in this-you don't think I want to see approval? I post what I post because it is solid DD based on facts straight from I3 and I feel investors deserve to know the whole truth-good and bad, to make informed decisions. That is what this board is supposed to be about! I backed up my posts/shared my sources with anyone that wanted to privately email me at cmossor@neo.rr.com. Many times shaka deleted it which he has no right to do if I can back it up! I bit by tongue for a loooong time until I felt Dean was sugarcoating things so much, and I knew it to be untrue. I also felt slighted that he announced his Alliance Venture while he still held peoples life savings and had the balls to ask his loyal followers for more, BEFORE satisfying his obligation to us. It tells me he is using his popularity for personal gain.
Yes the info I posted is NOW outdated IMGGORBUST as my correspondence I shared reflects the dates I received it from I3 (it wasn’t when I shared it) and I HOPE they have worked through the issues. I do not give a shit if the FDA, Dean-or anyone else sees this-the truth is the truth and I am an honest ethical businessman like many of you, I am also frustrated and fed up like many of you with all of the delays. I am not here to hurt, bash, or deceive anyone-only to help you the investor as you have helped me.
I have a hard time believing that the FDA is so inept that they can’t resolve “minor” labeling changes/wording/manual edits without asking for resubmission after resubmission as this has been going on now for three years! Something else is at play here, either Political or Dean is not being forthcoming about what “EXACTLY” the FDA had issues with regarding their latest response to him. Are the issues really minor as Dean stated? What were they and why won’t he inform shareholders what the specific issues were? We are all waiting on pins and needles waiting on the FDA to respond. I feel He already got his response back within the 30 days, (albeit informal as we are supposed to be on the fast track) that’s why he said “I do not know if this will delay the FDAs’ response or not” we already know it has because we are still waiting.
wallstreetgenuis I got my info from Mike Nessen at I3, I feel terrible making this public because it may cost him his job, he is a great guy with a good heart. The only reason I shared the info privately was because in his 1st email to me he asked me not to share it then immediately emailed me and said I could (I think he did not want to chance that he was divulging insider info) he can rest assured that the SEC can kiss my ass as I would never share it with them. (Email me wallstreet and I will send it to you.)
Again, like many of you I want to see this get done so I can move on-I hope it happens soon!I invite Dean or Mike to respond to me to correct me if anything I have posted is incorrect as they both have my phone # and email.
p.s investor trader you wrote; “…I [recon] have an email from Mike Nessen [IMGG’s Vice President of Business Development] stating that ‘Dean is working seven days a week trying to get the DVIS to work properly’…”
that email was sent to me in Feb or March so yes it is (hopefully) old news
Wut?
Wow you really belived me? Poor guy-I was hoping my figure of speach would not confuse anyone but I guess it did-sorry about that.
Lol wow I could not disagree with YOU more IMGG. We have heard that Dean has what, four successful prior FDA submissions? Who were they? What was the product? Do you know?. If his last submission is any guideline, I wouldn't let him do ANY FDA submission for my Cmpany-he has done nothing but mislead investors with his "I am waiting for my cell phone to ring any minute" rhetoric for three years now. You asked "Should he just be sitting around waiting for the fax to come in or another call from the FDA?" yes he should. Some investors (albeit novice) have their life savings invested with this guy and he has the nerve to ask people to invest more money in him BEFORE he satisfied his first obligation to his shareholders?.I have an email from Mike Nessen stating that "Dean is working seven days a week trying to get the DVIS to work properly" yet he has time to start another Company around that same time? People are in panic mode and rightfully so.
You said,” You really think Alliance was created just because Dean can inexplicably make a share price go up?” ABSOLUTEY, some people here think Dean is God, that everything he touches turns to Gold. Dean thinks that himself but it couldn’t be further from the truth. He is doing nothing more than profiting off of his popularity. The truth is that Dean tried to slide the DVIS by the FDA via 510K before it worked. Now they called him on it and he has to make it work. If he had all this experience getting things through the FDA we would not be having all of these delays. I hope he worked through all of the issues and approval is forthcoming but I do not know that to be a fact. Now we have him saying the FDA had “minor questions” but he will not say what they are and he does not know if it will further delay the submission. I think we all the answer to that one as the very latest was supposed to be today according to your posts.
Waiting for Dean to fulfill his first obligation before investing anymore money in him.
Then we beg to differ, it started out as a process and has now turned Political-that’s just my opinion (and Deans by the way) Not many here have done as much DD or has as much to lose as me my friend, send me your email to cmossor@neo.rr.com I would like to see all of your personal correspondence with Dean and Mike Nessen and I will show you mine ok? I got most of my facts about DVIS from them-I hope you are right, I want approval as much as anyone but I am a realist.
I did not say there are currently offers on the table, I said Dean has turned down offers in the past-listen to the CCs from last year. Borntwice, Obama is there NOW isn't he? I have just as much right to speculate that Politics are holding this back as you do saying it aint so-again, listen to Deans conference call back in NOV or DEC he feels the same way. If im wrong then Almighty Dean is wrong too. lol
here you go my freind.
http://www.caliso9000.com/fda_510k.html
Agreed investor_trader , Dean wants to run with the Big Dawgs and Obamas’ Buddy Immelt at GE is saying Uh Uh. Nothing else explains an average 90 day submission taking three plus years. I can see Dean selling out to Toshiba once he gets it through his thick head that he is not going to get approval. Hope I am wrong.
interesting link on how FDA approves submissions (at least in hte aithors view)
http://knol.google.com/k/anonymous/fda-food-and-drug-administration-and/z4f4glxdf146/4#
I do not think it should be the FDAs' business to say wether it works or not-rather is it safe or not. If it does not work than people do not have to buy it.
Well said Born, I too hope all the bugs are worked out and that we can get on with ramping up production after approval.
Right Joe and I only ever posted FACTS about the Company, FACT is that a few people only want to hear the good, I believe in the DVIS but I think I MAY HAVE (I hope I am wrong) been misled and misinformed by Dean and I am not happy about it. He has been saying that approval is "right around the corner" for THREE YEARS NOW, Cmon- You want me to post facts Joe?
FACT- "the images we’re generating right now are a proof of the concept and technology; it works, now we need to focus the lens to draw an analogy"
FACT: "we are WORKING ON things like gantry to cart communication speed, gearing, gantry balance and other items that make a complete system that can be used reliably in operating room. We are working seven days a week on that"
FACT: "The images will continue to improve and we will / are doing high resolution scans of a hand, skull and torso with lumbar spine."
Do any of those statements sound like they have a finished product ready to be shown to the FDA and put on the production line? NO! it sounds like a work in progress to me. As I said, Dean tried to slide an “IDEA” a “CONCEPT “by the FDA and they called him out on it, THAT IS WHY ALL THIS DELAY! Because now he has to make it work! THAT is why I believe he misled the shareholders! He wanted to get his concept approved via a 510K submission and worry about making it work later.
These statements were made by an employee at IMGG, SHAKA will delete this post because it says something negative about the Company. If he does it shows his biased because these statements are TRUE and I can prove it. Send me your private email (cmossor@neo.rr.com) shaka and I will send you the info. If I can prove it to you then you have no right to delete it and I will turn you in for it.These statements were made less than 90 days ago. It may be "old" news now but I have been saying it for two months now and you keep deleting my posts and the members of this board deserve to see it. I have not heard anything from the Company SINCE then so I cannot draw the conclusion that they have worked out these issues until I hear otherwise. I don’t know how you consider this bashing Joe as you are privy to this same info-it is negative, but true. I only deal in FACTS and draw my conclusions accordingly.
I SHOULD be keeping this to myself as I am heavily invested here but that is not my game, I try to help other people make informed decisions and I feel compelled to share it.
You tell them you have a great product that uses off-the-shelf parts and hope they say OH ok great APPROVED!
(by the way I3 submitted their 510k in February 2007 how many years is that?)
Lol yea this is a real fast track my freind. FDA is STILL taking the absolute most time allowed, this leads me to believe there are STILL issues, nothing else explains it. They have had Deans submission for a Month now, how fast it that? You call that reaching out and embracing Dean? LOL same old song and dance!
I agree with much of your post Madtig, especially the part were we are fortunate to have a dialouge with the Company. I disagree however, that Dean has been forthcoming. I Ask others that I have privetely shared info with to weigh in. I3 has had many issues regarding mechanics, vibration, software crashes and such that-in the end-could result in the DVIS being denied on their 510K submission.
Some of you "drank too much of Deans Koolaid" He was not as forthcoming with the issues as he should have been. You only hear the good-not the bad from him. Just my honest opinion, I am pulling for them and hope we get approved.
what you don't know Shaka is that is has not been all peachy over at I3 as 50 people that I just emailed found out. they have had issues with software crashes among other things that in my opinion has been the reason for all of the delay.Dean just doesn't want you to know that.
I was being sarcastic sir, Dean said he has not presented it to one yet.
So he hasn't even conferred with a Radiologist yet?
Jake send me an email cmossor@neo.rr.com and I will email it to you because I did copy it. This CC confirms for me that the guy was legit because he said to expect PR any day now.This is part of what the post says;
They are currently finalizing the packet to resubmit to the FDA, this could happen any day now. After the submission they will be doing a PR and uploading the high res images to their Website.
CHA CHING!!!
Well said Bust
One would think that one holds a CC to "put it all on the table" but still not good enough for some "one". One still has to complain. Ine would think one wouldn't.
Excellent post Elhefe I could not agree more.
The FDA release will not affect their 510k submission at all people, here is an email I received from them. It is my understanding that the process with the radiologist review is almost complete and is going VERY well. Better than anticipated in fact. Dean is being very thorough and will be submitting very soon. If any of you want to be on their mailing list just let them know.
I have heard from many shareholders regarding the FDA’s press release that was issued today in regards to radiation exposure from CT, Nuclear Medicine and Fluoroscopy imaging devices. The goal of this e-mail is to communicate Imaging3’s Management point-of-view that this will NOT affect our current 510(k) submission for the Dominion Volumetric Imaging Scanner (DViS).
Two key paragraphs (paragraphs 10 & 11) of the press release are copied below and are worth comment and help explain what the FDA is doing and what these changes mean to Imaging3, its Shareholders, Customers and Employees. A link to the FDA website and release is also listed below.
From the FDA Statement:
“The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.
Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.”
This link http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200085.htm will take you to the full press release from the FDA.
After reading the press release Dean Janes quickly determined that this press release does not impact the current 510(k) now in progress for the Imaging3’s DViS imaging system.
The FDA is at the early stages of this process as indicated by the public meetings they will hold on the topic and they discuss the need for a National Registry and Dose Registry to track patient life-time exposure to radiation. These databases are far from complete. While I don’t know this definitively I do not believe that work on these databases has even begun. These databases are major, multi-year process to build let alone integrate them with imaging devices nationwide and other data source that would be needed to make these system viable for the healthcare system generally.
In summary, the FDA will not have these initiatives converted into policies or laws any time soon. Imaging3’s Senior Management believes that we will be past FDA approval for the DViS when these new regulations hit the books.
As we learn more about these policy changes we will keep you informed.
One last thing, many of the requirements that are listed in the press release are doable now with the DViS. Even if this was implemented much sooner than we think is possible we do not think that it would be a major problem.
Best regards,
Mike Nessen
Vice President, Business Development
Imaging3, Inc.
3200 W. Valhalla Dr.
Burbank, CA 91505
Mike@Imaging3.com
800-900-9729 ext. 102 (office)
818-260-0930 ext. 102 (office)
818-260-0445 (fax)
Shaka Can you inform people how to take the survey please? I was not sure if you meant to post a message to be informed or not then I found the SURVEY button duh on my part, I would like to see as many people take the survey as we can get.
thanks
We were discussing in earlier posts about the desire to be informed or not informed. What do you guys think? We all know Dean watches his beloved Ihub (the best investing thread on the net!)This is your chance to tell Dean right now; As an investor, would you rather be informed on the Company’s' progress towards FDA approval (or for any issue for that matter) so as to make wise investment decisions based on "current" news? or not informed meaning only the end result really matters? I think these are two very important questions, let Dean know what you think!
Informed
Not informed
Are you kidding me? In one breath you said you do not want to hear worthless press releases and the next breath said you want to hear how the FDA progress is going. That is exactly why Dean did the Money TV interview to update us on the FDA progress. Can you tell us exactly which press release was worthless? Which scenario would you rather see?
1. Well I heard nothing from Dean for two weeks that tells me he doesn't care about his investors, the pps is going down every day-I have to sell out man I DO NOT KNOW WHATS GOING ON WITH THIS COMPANY!
2. Ok they put out a PR this week and said they answered most of the questions the FDA had, they are working with a private radiologist consultant, said they are making great progress and will be resubmitting in two weeks, Dean cares enough about me to keep me in the loop-I better buy more shares the train is leaving the station!
Companies are supposed to keep the shareholders up to date; we have a right to know. Seriously people, please respond to which scenario you would rather see one or two.
Many investors have been posting questions about imaging, FDA status etc…. I think that Dean has made significant progress towards satisfying this latest FDA request. A few thoughts;
•Dean stated they have answered many of the questions the FDA had, and I understand that the few remaining questions are basically non-events.
•Dean said during the CC that he is very happy with the new review team. I believe they had a conference call with them and answered many of the questions already. It sounds to me that they are able to confer with the review team now at will, rather than waiting for 30-60 day response times.
•Many investors want to see high res images on the web site. I would think that this is the least of their concerns at this time as they are busy preparing the submission to the FDA. I think Dean needs to concentrate on submitting the requested images, and then post them on the web site.
•Really the only significant issue that remains is the Radiologist review. Dean is currently collaborating with 3rd party radiologists to compare the DVIS to the predicate devices (fact) and It is my understanding that because the Dominion uses the same off-the-shelf parts that this is very easy to do. It just takes some time to put these things together.
These are all positive signals my friends, Not one shred of evidence that this will not be approved. GLTA!
Tattooed, I got the same impression awhile ago,now you watch-Dean has a meeting "meet and greet" with GE coming up next week. I see an offer being made and Dean accepting it because he knows Ge is pulling the strings. Look the FDA has bee dragging this out for three years (the average 510K application takes an average of 78 days according to fda website)and Dean even made mention that the FDA has overstepped their boundries regarding "other market forces" playing a part in this latest delay.
I am going to gather some facts and forward them to every media outlet I can think of. Fox news will have a field day with it. If anyone can help me out you can send your info to cmossor@neo.rr.com. I have good contact info for people like Glenn Beck. Orielly etc..
Thanks for the update dean! lol
Interesting though that the average length of time for a decision on a 510k application is 78 days (per fda website)this has been going on now for three years? One would have to think that someone like GE/Toshiba doesn't want to see this thing get approved.