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Correct. By putting the specific calendar time period in there, I thought that was clear.
However, I think the other fellow meant that he didn't hear Dean say that the FDA would respond to him in 30 days. He did say it. I believe the FDA's guidelines call for 60 days, but Dean said it is and has always been 30. I'm going with the guy that has done this 5 times.
Here's why I think you're wrong to be considered about those two items:
Re: the comparative analysis, the Company is in the driver's seat there. While you're correct that it is totally subjective and open to interpretation, that would only matter if the FDA was conducting the analysis. They're not. The radiologist (or radiologists) who will conduct the analysis will be hand selected by Imaging3. He will be paid "for his time" by Imaging3. He will share his findings with Imaging3, who will decide whether to then share them with the FDA, or to seek the analysis of another radiologist. There is zero room for trouble in this process, because the Company completely control the process. I also can conceive of no explanation as to why it would cause "significant delay." Dean explained that the most time consuming part of the process will be obtaining images from competing devices to which the Dominion has been compared for substantial similarity. He already said he has so many contacts in hospital systems and radiology groups that it will not be a "significant delay," but will take a week or two. That's not significant delay. The analysis itself will take no time. It's not a clinical study where you need data sets over a period of time. The radiologist will literaly just look at the images from the various devices and right a few page report. Non-issue, and people need to stop worrying about it. Frankly, I think it is the easiest of all the items raised by the FDA, because the Company is in such control of it.
Re: Structural Integrity: You would be right about a possible delay related to the structural integrity issue, if the engineering analysis was not ALREADY COMPLETED. Dean explained that they conducted complete engineering studies of the structural integrity and already had the reports that demonstrate its soundness. That's one of the items the Company has already put a check by, complete, done, what's next?
The last few days have been rough to watch, and I know it is causing a lot of skepticism, but Dean and Mike already assured us that there were no game changers in the FDA's list of issues.
They will have answers to all of the items done within 2 weeks, and the only item that could potentially take longer than 30 days to finalize is the comparative analysis, and that's only because it may take a little bit of time to get the images from the other device.
I believe, as Dean does and has stated, that he will get those images quickly, get the analysis done quickly, and get the full response back to the FDA in less than 30 days. From then, I agree with Dean that we will hear in 30 days or less from the FDA. That puts us at approval in late March but before the end of March. That's not too long for me to wait for the pot of gold.
Most of the items raised by the FDA this go around were of the same ilk as "label" questions. For example, cleaning up typos and the like in the service manual. That's the sort of stuff the agency inquires about when it is comfortable with the technology itself. Indeed, Dean and Mike both expressed relief that not one single inquiry in the current batch relates to "the technology." Even with new reviewers, we appear to be beyond any safety questions. Note of most significance to me, was the complete and utter lack of inquiry regarding anything to do with radiation or medication. Those were the issues people seemed to be sweating the most due to recent FDA press. Neither is an issue being raised by the FDA and that is extremely good news towards quick and easy approval at this stage.
I'll go one step further. It's not a question of whether the FDA will approve on the next submission, but simply whether they will ever approve it. I believe we are in the final throws, but regardless, we know where it's going upon approval (at least $2, more likely $5 - $7), so if you think it's every going to approved, then you should be gobbling this thing up at these prices. Pretty simple.
Just so you're not holding your breath for the image on the website, Dean made it very clear that he was not going to be putting any image up on the website until after they had their meetings and "dog and pony show" with the GE and Toshiba folks and other potential suitors. Those meetings are already scheduled and they are coming up soon, so it won't be long before the images are up, but it will not be within the next week or two.
Now an update about his call with the FDA would be very nice. Something to report that the call went well, just based on the call, half of the items on the FDA's follow-up list have been dropped. The FDA implied that a complete response to the remaining items is all their looking for. That would go a long way for sure, and I do hope we hear something like that soon.
Re: Vibration
During the CC, Dean explained that one of the follow-up inquiries from the FDA was whether Imaging3 had conducted a certain type of structural integrity analysis, which identifies issues related to vibration (in terms of the rate of speed and rotation of the device). Dean explained very clearly that Imaging3 had indeed already conducted the very analysis about which the FDA was inquiring, and that the DViS passed that test with flying colors. Responding to that item will take 0 time because the data already exists, and in fact, had been provided to the previous FDA review team.
This is a non-issue.
Mid to late March.
Exactly. That's why it's a non-issue in terms of approval. It's just to paper the FDA file and give them a little CYA.
No matter what, there will be issues with impartiality. The radiologist is going to be selected by Imaging3 and paid for their time by Imaging3. That's why the request by the FDA is so stupid. There's 100% chance we're going to get the report we need, so why bother going through the exercise. It will just take a little bit of time, and it will get done quickly, and it will say exactly what we want it to say. It's a non-issue.
Sorry but there are a lot of misleading statements in your post that simply must be corrected:
1) Radiologist Review: The radiologist review will be very quick. It will be complete and ready to go with the entire package by mid-February. It is not an extensive exercise. Look at the images from the DViS and like images from the substantially similar device Imaging3 identified in its 510k. Then he'll write a few page report saying they are similar and of similar quality, and he's done. It's not a big deal. It's also going to be a radiologist of Dean's choosing, and he can keep back to the well until he finds one willing to say whatever we need the report to say. It's a waste of time, in my opinion, but if the FDA is asking for it, Imaging3 will deliver it.
2) Simulataneous Response: Of course he will be working on all 14 items at the same time. He will line out the radiologist to do his work and start gathering all the other information and preparing his response at the same time. Where would you have ever gathered that he would do otherwise. Dean explained that he was confident he could get all of the responsive information cobbled together and the package response back to the FDA within the 30 day deadline he has to respond, and that's reasonable. He will cross all his t's and dot all his i's and this will be the last go around.
2) Conference call with FDA: I have no idea where you get this nonsense about the call with the FDA taking an undetermined amount of time to set up if the FDA will even go for it. We already know the FDA "will even go for it" and we know it will be within the next 2 or 3 days because as of Tuesday's conference call, the FDA conference call was already set up, and we already know who was going to be on the call, the reviewer and the head of the Devices division at the FDA. Dean said so on the call. Finally, the call is critically important. He has to have it to make sure he understands with 100% clarity what the FDA is looking for. That's how you avoid another follow-up inquiry by the FDA. It will also give him a chance to pressure them a little bit about making this the last and final round of this nonsense. He will also get a chance, as he explained on the conference call Tuesday, to try to answer some of the FDA's questions during the FDA conference call so he can scratch them off the list of 14, possibly cutting the workload substantially and enabling a response to the FDA sooner than mid-February.
I know this process has been frustrating, but it's time to just cool down, relax and wait for the inevitible.
Radiologist Review:
There really shouldn't be any concern at all about what the radiologist is going to conclude. The Company gets to select the radiologist, and frankly, can select radiologist after radiologist until they hear the result they want. That's why, as Dean properly noted, this exercise is absurd, and clearly has only one purpose... FDA CYA. If there is a paper in the file from an outside radiologist, then the FDA can check it off their list and always say they relied on the outside radiologist. It will take a little bit of time (not too much) and it will get done, and his report will say exactly what everyone knows it will say.
Nothing has changed from last week to this week except for the date. Last week we were anxiously waiting FDA approval, knowing the stock was skyrocket upon the news. The news will just be a month or two later now, but it's still the same news, and the result will be the same.
Anybody that is selling for a loss right now is foolish. Hold tight, load up more if you can, and wait for the inevitible. For me, I'm long and strong, but I may not lurk around here quite as much because there isn't going to be a whole lot to learn or to report on until mid-February.
Best of luck everybody.
Here are my notes of the highlights of the call:
Dean's Remarks:
Over 1,000 participants on the call.
Original reviewer from FDA for our application is gone, as is the head of the CDRH. Accordingly, we have to get new folks to a comfort level. They have been engaged and been reviewing and have come come back to the Company with some more questions / respnoses (18 total items):
14 clean-up application suggestions (service manual and other information to clean-up)
3 information requests (related to engineering and test information, mostly regarding information that has already been provided and follow-up re: vibration, structural integrity and other technical issues)
2 actual questions (interpretations of imagery).
The most significant follow up request is that the FDA would like us to have a radiologist provide a Comparison Review Opinion. CEO has good relationships with many radiologists, and many radiologists (hundreds of them) are investors in the company, so the Company should have no problem finding a radiologist to do this quickly. Will also need to obtain images from other competing machines to compare with DViS images. CEO has gathered that the FDA does not have a radiologist on staff, so they want us to have the file papered with a blessing from a radiologist.
CEO has a call scheduled with the head of CDRH and the reviewer to discuss the requests, get clarification and agreement about an acceptable response.
CEO expects to have response to FDA by mid-February (could be sooner, could be a little later). Most of the items should take no more than 2 weeks to respond to.
Process has taken far longer than CEO expected. He feels as confident as ever that we're going to get this through. CEO expects approval by the end of the first quarter or the very beginning of the second.
Q & A:
Question about burn rate / cash on balance sheet / earnings. Company has more than enough capital to survive this delay. We have adequate capital to survive this entire next new year, and in addition, I have also obtained a credit facility in excess of $900,000 (not yet drawn upon).
Question about making images available to shareholders: Trying to get images on website as we speak. Hope to have them on the web shortly.
Question about where CEO thinks we are in the FDA process: In these type of reviews, you don't tend to go backwards. What's good about this follow-up inquiry from the FDA, like the last one, is that the questions being asked are in a pattern of "clean-up and clarification." Many of them were already answered or are in the application itself. Most importantly, there's not a single question about the technology. They were mostly questions about our application. 2-3 with any meat at all, and even those have to do with clinical comparisons, which is a very good sign.
Question about FDA not agreeing that 510k is the right application: FDA is on board with our product being substantially equivalent.
Question about communications with GE or Toshiba: CEO has a conversation with them coming up and a meet and greet with them in a couple of weeks. We're open to manufacture and take this to market ourselves, but would also be willing to partner with the big industry players, or do whatever makes sense, including an acquisition. If the price is right we would consider an M&A.
Question re: impact of Health Insurance Reform: CEO believes the health care reform really helps us. Our product does multiple procedures, it's mobile, and it's less expensive. That's what the reform effort has been all about.
No offense taking. However, I read our statements mean the same thing. I used the word "guideline" as opposed to "regulation" for a reason. The performance goal you mentioned is from an FDA guidance document that the FDA uses to guide its internal operations for handling 510k applications. I agree it could take longer than 60 days, and I assume you agree that it could take less than 60 days. My point is, and I think we agree about this, the applicable guidance (aka, the applicable goal) is the 60 day mark, not 90 days, and not 30. After 30 days, the Company can contact the FDA for a status update, but the operative goal/guideline is 60 days.
It's not a matter of fault. Nothing blameworthy has been done. It's just a matter of the FDA overkill. They are entitled to do that, and they are doing it. It's frustrating to all of us, but we are seeing this in all areas of federal regulation now. For example, the FTC is making a much higher percentage of second requests for mergers and acquisitions, they are waiting to hear from more people in the room and approvals or challenges to deals are taking longer. We've just gone from a rubber stamp regulatory regime under Bush, to a more deliberate one under Obama. Notwithstanding the longer deliberation, the end result has tended to be pretty consistent with the previous administration. Obama and his war counsel took a long time to consider its Afghanistan strategy, but in the end, they ended up doing pretty much exactly what Bush would have done, just a couple of months later. I think we can expect the same for DViS FDA approval. It might take a little longer, but I still consider it inevitible.
By the guidelines it would be 60 days, but as always, it could come much sooner. It really depends on the nature of the follow-up questions. If they are simple and straightforward, and the information in response is also simple and straightforward, it could be a matter of only a few days. "We need to be able to check X, Y & Z off our list. I see you have X, Y & Z. Thanks. Here's your approval."
Thanks. A couple more jackals and this place could start to sound like the Yahoo Board. I can't spend 10 minutes over there anymore. I wish you luck in moderating this board. It can't be easy.
Without reference to a specific poster, can someone please advise if there is an option on this board to automatically ignore a specific poster, who, if I believe in my opinion, is just wasting time and space, I can eliminate from appearing on my screen?
Thanks in advance.
Very encouraging message from the Company. Thanks for sharing. Was that from Nessen?
Company and/or Dean Buy Back:
Today, of all days, would be an excellent time for Imaging3 and/or Dean personally to start buying back some IMGG shares. I would love to get that kind of a confidence signal from the Company. I think if the market observed the Company buying its own shares on the heels of this announcement, it would go a long way to cooling the little panic I'm sensing.
From Dean's Facebook page:
In response to a friend's message yesterday at yesterday at 6:12pm
that stated: "have to get it off my chest, "freakin' FDA", "WTF is up with this bureaucray bs?" zeeeeesh! Can't imagine how frustrated you are with this process!"
Dean replied: "Welcome to my world! If you only knew half of the bs you would be against govt run anything!"
Yesterday at 6:42pm
FWIW
The call is at 4 PM Easter, after the market closes.
What a completely pathetic post. An FDA request for additional information, which is extraordinarily common, can be as simple as changing wording on the label, a la, the exact type of request the FDA made last time. What a joke, and how irresponsible to suggest that responding to an additional request could take a long time or could bankrupt the company.
We are in the same boat we were in in November. Dean and team will responsibly and efficiently respond to what may be some very basic and simple questions, and then we continue to wait for the FDA to do what we all know is inevitible... approve the DViS 510k application.
Strange parsing of language there. The "quick" reply last time was 17 days, and it was multiple questions all of a similar ilk. I expect the same this time. Also, plans to respond, really just means, we expect to respond by X date, and this will be the general nature of the response. Don't get carried away with the semantics.
Oy:
Sent: Mon Jan 11 16:11:42 2010
Subject: Imaging3 Newsletter
Imaging3, Inc. is pleased to announce that on Tuesday, January 12, 2010 at 1:00pm PST, (4:00pm EST) the company’s CEO, Mr. Dean Janes, will be hosting a conference call. To join the conference call, please call 1-877-757-0918 and enter passcode 681029 followed by the pound sign (#). You will be connected to the conference call in a listen only mode, and then lines will be opened for questions following the presentation.
The purpose of the call is to update Shareholders and other interested parties of the current developments with the company’s 510k FDA submission. Currently the FDA has requested further information and Mr. Janes would like to discuss the company’s plans to address these questions.
A recording of the conference call will be made available on the company’s website as soon as it is available. Imaging3 will notify shareholders and others who are on the company’s e-mail opt-in list. Anyone who would like to be added to this list is encouraged to sign-up for the e-mail based newsletter on the company’s website using the following link - http://www.imaging3.com/newsletters_signup.html.
If you have any questions, please feel free to contact me by e-mail or directly by calling (800) 900-9729.
Sincerely,
Mike Nessen
Vice President Business Development
Imaging3, Inc.
Burbank CA 91505
(800) 900-9729
mike@imaging3.com
www.imaging3.com
No, you're wrong. SEC law requires the company to advise the public of any "Material Information" it obtains, not just approval by the FDA. An FDA request for additional information is undoubtedly "material information" as defined by SEC law. If Imaging3 had received a formal response of any kind from the FDA, that would undoubtedly be "material information," and the law requires them to publicize that fact. The fact that there has been no update means there has been no material information received by the company in the past 72 hours. Take a deep breath. Relax. No news from the company means no news from the FDA.
Think about how it would look to prospective investors to look at the historical Press Releases and see a list of back to back to back Press Releases saying: "we have nothing to report." That would look amateurish and stupid. There is no advantage whatsoever to the company (and therefore all of us) to putting out a press release with no new information in it. He is doing the right thing, and everyone just needs to calm down and continue to be patient.
No offense, but I think that's a little silly. It would be illegal for him to receive and not share material information. We can safely assume that he has not received any word from the agency. A press release to announce that the status has not changed at all, is a bad idea, and should not be done.
I agree completely. I can't look at the Yahoo Board for more than 5 minutes without throwing up in my mouth. However, even with our collective patience over here, there is usually quite a bit more discussion on this board on a trading day.
Consider that this is most likely Approval Week, this Board is eerily quiet.
Wow. The possibility of having to wait until the end of December (less than 3 weeks from now) causes you despair? Remember all of these dates thrown out there are based on FDA guidelines, not regulations. I would say Tuesday the 12th is really the earliest anyone should have ever expected, and I would expect to hear from the FDA any time between the 12th and the 19th.
For all we know, it was already included, and there's nothing new to add. Regardless, the DViS does not change at all the way imaging drugs are used, nor does it introduce any new safety issues related to the use of imaging drugs in conjunction with an imaging device. The primary "new" aspect of this device is the software package that allows for images to appear in high quality resolution in real time with less radiation. Accordingly, the new guidance document will have no effect whatsoever on the substantial equivalence evaluation (which was probably completed 2 and a half years ago) or the approval evaluation. We are good, and we will get word within the next 11 days.
To be clear, Dean did not post a link to this FDA News Release on his FB page. Some random guy posted it on Dean's page and asked for Dean's thoughts about it. Dean did not respond, as I would expect, because FB is not the place for him to offer thoughts about an FDA process relevant to a publicly traded company.
To the extent the FDA's new "guidance" document applies to the DViS at all (and I don't believe it does), it provides a lot of textual indication that so long as the Imaging Drugs are being used in the same manner as they have been for previously approved devices, then there should not be any hang up for approval of the new or modified device. In other words, this is another non-issue that bashers are trying to make hay out of.
Be patient everyone. 60-days has always been the relevant time period. The FDA approves within 60 days of the most recent submittal in response to a request for additional information 90% of the time. That puts us somewhere between Jan. 12 and Jan. 17. Until then, just be patient and ignore the bashers who will try to do anything to shake your confidence... including posting deliberately misleading statements and outright lies.
Per the BioMed Report: "In the last conference call on 08/19/09, CEO Dean Janes stated that the FDA had requested some images previously not asked for."
Additional Images NOT Better Images. The FDA approval process is a confidential one. We have no idea what was actually said by the FDA. All we can go on is what is shared by the CEO of the company. Nobody, other than bashers, has ever said that the FDA had a problem with the quality of the images produced by the DVIS. They asked for "additional" images, according the CEO of the company. There is a huge difference between requesting better quality images and requesting additional images. Just as likely a scenario is that Imaging3 had provided images of certain parts of the body (e.g., a hand) and not others (e.g., brain scans), but indicated in intended use statements that the device also works on those other parts of the body. Accordingly, it would make perfect sense for the FDA to come back and say, we would like to see images of that other part of the body; i.e. "additional images."
I hope you are just be reckless in talking about things you don't know in this negative way rather than deliberately trying to mislead people.
First of all, the FDA never "rejected" any image. Ever. That is a lie, and you're best to stop propogating lies. Second of all, nobody is talking about the FDA getting upset about new images being circulated. The point is very simple and try to keep up. At this stage, there is one end game here, and one end game only. That is FDA approval. The more documents you produce, the more marketing material you generate, the more images you create, the more the FDA has to review. The more the FDA has to review, the more time it will take. There is simply nothing at all to gain by creating a single shred of paper, data or imagery more than what has been requested because the more that's out there, the longer the review process will take. He's given the FDA what they've asked for, and anything else he does is unnecessary and will cause delay. He would be foolish to start cranking out new materials beyond what the FDA has asked for. Not because it would "upset" the FDA, but because the FDA would surely take additional time to review whatever new material is out there. That's the downside risk. More material equals longer review time. What's the upside to it? To keep you from whining? How does that help the company? It doesn't. The only thing that helps the company is FDA approval and he is playing it just right in that regard.
You mean like this: http://www.imaging3.com/video_imaging3dominion.html
Apples to oranges again. What does High Definition Video have to do with 3D fluroscopy? The DVIS is designed to create an image and show it on the hardware next to the machine in the operating room, or in the trauma center, or wherever the medical work is being done. It's not designed to email video or download it to public media outlets for public consumption. I agree, it would be awfully nice to be able to throw an image up on YouTube to stop all the whining out there, but that's not how the product operates. What makes it a breakthrough technology is the software and hardware that enables high res 3-D images to be viewed real time. That fact, that it's a breakthrough software and hardware package that nobody else has also means you can't just pass it around and view it on some generic media viewer. If YouTube had the software that allowed us to view DVIS images, the DVIS would hardly be breakthrough, and wouldn't be worth a lick.
You're comparing apples to oranges. A kid taking a video on his cell phone and putting that jpeg on YouTube is entirely different than viewing a 3D image designed to be viewed on DVIS hardware operating on DVIS software.
Why would he need to bring "new" images to RSNA? What would we expect to be different from 2008 to 2009. It's the same product creating the same images just waiting for FDA approval. Dean explained that he doesn't want to rock the boat, and I agree with the strategy completely. The FDA has the images they've requested and all the marketing material that Imaging3 has generated. The minute Dean starts introducing new images or new marketing material, that is just more for the FDA to review and can only result in more delay. Just let the FDA do its job, as painfully slow as that may be, and as soon as the approval comes (I predict next week) then we will see all new marketing material and all new images and a lot more money for investors.
Your little scheme to scare people about images is so transparent and pathetic.
Some info regarding the quality of DVIS images:
Re: the 2008 RSNA: "The reaction of doctors and other radiology professionals to our new images and future product plans was all positive and we are very happy with the way our technology has been received.”
Re: The 2008 Frost & Sullivan North American Medical Imaging Product Innovation of the Year Award: DVIS was selected the Innovation of the Year in the field of Medical Imaging after the "analyst team conducted "extensive primary technology research," which undoubtedly involved reviewing images produced by the device.
There's feedback from radiology professionals who have seen images. There's this bizarre myth out there that Imaging3 is hiding the images from the public. That's totally false. The issue is, you can't just PDF a 3-D image and email it out for public consumption. The product functions because of the software that is part and parcel of the product. Without the software and the hardware on which to view the images, we can't view images on our PCs. However, the images were available for viewing at the RSNA on the DVIS hardware. The images are always available to be viewed at Imaging3's offices in CA on the DVIS hardware. The FDA has seen them and has approved the product for trials based on the images they've seen. They have not asked for additional images during this final push towards approval. Don't by the scare tactics and the myths. The product is a homerun, and that's why it's received accolades wherever it's been unveiled. Sit back and enjoy the ride. FDA approval is right around the corner (I'm predicting Jan. 11 - 13).
There is no "limited use"
I'm so tired of people posting here, unchallenged, that Dean submitted a limited use of the DVIS in response to FDA's label inquiry about intended use. Dean could not have been more clear that the FDA was seeking a "more generic" explanation of intended use; i.e., less specific, less tailored, and less limited. Whereas the original lable identified specific procedures and specific functions within a body of medicine, the FDA asked him to be more generic and just state that the device could be used generally in that body of medicine. He gave specific examples on his call for crying out loud. Rather than saying Pediatric surgery, pediatric examinations, pediatric whatever, just say "pediatrics". Accordingly, the potential use of the device was EXPANDED in the revised filing, not made more narrow. Was the only one actually listening to the call?