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The rise will begin closer to April 5th. I think this Friday will be a big day.
It's pretty self-evident.
Here's why:
Imaging3 is not going to submit the package to the FDA without a report from at least one expert, third party radiologist concluding that the images from the DViS are of at least the same quality as the devices to which the DViS is being compared for purposes of its 510K application. Accordingly, the submission of the package is huge news because it also means we have an official unequivocal endorsement from a professional, independent, expert radiologist. Huge.
I agree it will be less than a month. I'm predicting we submit the package by the end of next week, and have approval about 3 weeks later. It's a fairly dense package they'll need to go through, but they know exactly what they're getting, and if it all says what they have been told it will say... stamp.
That's a pretty short term (and short sighted) view of the share price. You understand that less than six months ago, IMGG was trading for .04 cents? It's now hovering around .70. I'd say that an increase in value by nearly twenty times in six months does reflect the high demand in which third parties hold Imaging3. And all of that with a product that cannot legally be sold yet. When the DViS gets FDA approval, around a month from a now, this thing goes through the roof.
He absolutely did NOT say he was leaning more towards manufacturing. He specifically said that he could not say that he was leaning one way or the other. He also did NOT say 2 units per month. He said they had 2 units right now, and that the process of manufacturing would be a steady ramp up period.
He will never say that he has no intention of manufacturing. The threat of going it alone has to be there to drive up the sale price. There will be a bidding war. Sounds like it's already started.
First of all, it's not true that you don't need agency approval to sell a radiation emitting medical device "over seas." The European Union and individual nations in Europe do have their own version of the FDA, and the same process we are following here would have to be followed there. Dean addressed this in the last call. The EU will accept FDA Approval to allow for sales in Europe, but the same is not true vice versa. In other words, if you have to go through the process of getting approval, get it from the agency whose approval really allows you to sell everywhere.
Second, selling the device overseas, before you tap into the huge market in the U.S., opens you up to the rampant theft of intellectual property in other parts of the World. If you start selling this thing in China, it will be copied and we'll find ourselves in IP litigation for the next couple of years.
Third, we are a week away from submitting our package to the FDA and a month away from FDA Approval. Why rock the boat with the FDA in the meantime? The FDA considers any piece of information about your device to be fair game in its review process, so the minute you start marketing overseas and seeing data coming in from consumers over seas, we put the whole review process on hold again, while the FDA requests and reviews all this new data.
Finally, the business plan here seems pretty obvious to me. We get approval, and before we start pouring mega money and resources into manufacturing and distributing, we sell to one of the big players. Dittling around with overseas sales means you start pouring that money and resources into manufacturing and distribution when you may not need to.
Moral of the story: (1) it's not as easy as just packing up a truck with a bunch of DViS's and "selling overseas"; (2) you run a big risk of having your intellectual property stolen; (3) you run a risk of delaying the FDA approval process; and (4) you spend money you don't have to.
I understand that there are some additional, and quite time consuming, steps that need to be taken with your brokerage in order to be able to sell them after they clear. That could be a few more months on top.
It's not even going to be close to late this time. The extension was good through April 5 because the extensions always come in 30 day increments. Dean is going to beat that mark by at least a week. I'll bet we're in by the end of next week.
He just shared it with you. And it's pretty consistent with Dean alluded to on the last conference call. He all but said that Toshiba is jumping out of its skin to buy this device.
There is no regulation preventing negotiations at this time. Indeed, he could sell the company pre-approval if he chose to do so, but he would never do that because the company will be worth so much more after approval. Rather, he can set the stage now for a little bidding war among the big fellas the moment we get approval. I believe that's what he's doing.
We will have a dramatic pop, but not like that. $3.50 - $7 is more realistic.
Actually, I wouldn't count on weeks for a buyout either. I expect it to be days or even instantaneous.
Generally, the term of a patent is 20 years. During that 20 years, you have exclusive rights.
Imaging3's patent.
No chance.
I expect the submission will be made within 2 weeks.
I'm not sure why the 10 hours per week on his other venture concerns you. A lot of people seemed to think it was a full time job or something. For a guy that is probably working 80 hours a week, it was reassuring to me to here how little time his incubator was requiring from him.
Per Dean just yesterday evening, it will not be functioning for at least another week.
I don't think it's really up and running yet.
And great to see you LikeaHawk. We'll head out your way again to celebrate the approval soon.
I tend to agree with you there.
Or they work their tails off to make sure they get FDA Approval. If your takeaway from that call is that they are not doing everything in their power to get the job done, I'm not sure we listened to the same call.
I think what was made clear during that call, that most probably had not thought of, is just how complex the Radiologist Review is. It's not a matter of taking an X-Ray from device A and comparing to an X-ray from device B. It's about getting images of multiple body parts, from multiple devices, in multiple modes, set up the same way for each device, so that the comparison will be apples to apples. Getting these images from competitor devices is not an easy task. Indeed, one of the disadvantes that DViS faces is the very thing that makes it so valuable... it has so many functions, therefore, it has to be compared to so many other devices. If there was another device out there that was already on the market that did what the DViS does, we could just compare it to that. But there isn't, which is why we all stand to get very wealthy here. That also means, the comparison process is going to take a little extra time. Well, I'm willing to wait.
Thanks. Now here are my thoughts:
Here are the negatives:
First, I was hoping to hear that the package was submitted to the FDA today. It wasn't.
Second, they have not completed gathering all of the data needed for the Radiologists to conduct their review. They are close, but not complete.
Here are the positives:
First, Dean expects to get the package back to the FDA by April 5 at the latest, which is, at most, a window of ONLY 18 business days. If this thing was going to double on resubmission tomorrow, it will get to the same place in one or two weeks . In other words, whether it's today or 2 weeks from now, I suppose there's no real difference.
Second, Dean has been in much more regular communication with the FDA this time around. He has pushed them to say whether they have any other questions or issues, and, while the FDA is going to do what its going to do, so far they have not identified any new issues. Accordingly, we can expect approval if this package checks out alright. And he still maintains that we should expect an answer from the FDA within 30 days. So most likely, we're looking at approval before the end of April.
Third, Dean pretty much went as far as he could go without flat out saying it... Toshiba wants to buy this product.
Fourth, Dean explained in as clear terms as he has to date, why the images are not on the site yet, and if the FDA gives him the green light, he will put up the images used for the radiologist review after it is submitted. He als reiterated, as he has in the past, that there are no technical problems at all with the device or the images.
Fifth, Dean confirmed that he does not the PMA route as even a possibility, and that the FDA has not even mentioned it.
Finally, Dean explained that we will learn about the resubmission by a Press Release, and we know this thing is going to rocket up upon that announcement. Accordingly, there will be zero opportunity for people to buy back in on the way up, so that will reduce the number of people selling tomorrow and sitting on the sidelines.
So overall, I'd say this was a very positive call, we are fully armed with all the information we could possibly ask for, and the path forward seems to be clear of obstacles. We may see a dip tomorrow because people expected to hear that the package had already been submitted, but in my opinion, anyone that sells is very short-sighted. I do not expect there to be any staying power to a dip. I expect we will be sitting here around .70 or higher at the end of the week, and we'll rocket up to 1.50 the minute the PR comes out.
Stay long.
Below is my summary of today's conference call hosted by Dean Janes, the CEO of Imaging3:
Status of FDA Process:
• Imaging3 filed for a 30-day extension to respond to the FDA, and the request was granted. The extensions are always made in 30-day increments, so it is good through April 5, but Dean expects to file the response package much sooner than that.
• Dean has had two conference calls with the FDA review team, including the Head of the Devices Division and the Reviewer. On the first call, they trimmed down their requests substantially. On the second call, they offered some clarification about the few remaining requests.
• Dean feels really confident with this group. They are both responsive and intelligent. They recognize that the process has taken longer than it should have, but they're new and they weren't comfortable just rubber stamping the work of the prior team, but they are trying to be diligent now.
• Dean believes this was the last round; i.e., their requests/inquiries were exhaustive, and if they are comfortable with everything sent back to them, then they will approve the device. He does not expect new subjects to be addressed. Dean has inquired during the conference calls with the FDA whether FDA has or expects to have any other issues, and they have not identified any.
• FDA's Time Limit: Dean believes he will hear back from the FDA within 30 days of his submission.
• Imaging3 will release a Press Release when the package is submitted to the FDA, and he will also host a podcast on the company's new Investors' Forum on the Imaging3 website.
Status of Radiologist Review:
• Imaging3 retained 2 radiologists and is considering retaining a third medical professional as well, and they are set and ready.
• Imaging3 has accumulated most of the data needed for the review (they need data for each use for which they are requesting approval from FDA, which includes images of multiple body parts from multiple devices, in each mode of operation, set up the same way by all the devices). Dean had mentioned on the previous call that he hoped this would be done by the end of February, but he underestimated how long it would take to get all of this data for each application from all of the machines. The process is going very well, it's just taking longer than he hoped.
• Once all the data is collected and ready, the review by the Radiologists will only take a day or two, and then the report will be drafted.
• The specific opinion they will be providing is that the images are comparable.
• The report will be from the Radiologists to Imaging3, who will in turn submit it to the FDA.
• The process to select the radiologists was to find respected radiologists with more than 5 years experience and experience with both radiation and flouroscopy. Dean went to his pier group and found people easily.
• Until the process is completed, Dean can't identify what the predicate devices are that to which the DViS is being compared, but he can say they are both flouriscopic devices. One has a 3-D fluoro capability, but it is not real time.
• They are using images of phantoms (not humans) for the review.
Images:
• We have no problem creating images of any kind, high resolution or otherwise. The technology we use in the DViS is working perfectly.
• There are two reasons for the delay in posting images to the website:
1. Our priority now is FDA Approval. Our Marketing Material is reviewed by the FDA. The more they have to review, the longer the process will take. Dean is going to conference with the FDA to see if they have any issue with him posting on the website the images used in the Radiologists Review.
2. There is also a conversion issue. We are developing a tech solution for converting the images from their existing form on the DViS hardware, and making them viewable on the website in as high a quality as it is viewable on the device.
Production vs. Sale of the Company:
• We have literally hudreds if not thousands of orders lined up. They are just awaiting FDA approval. We do have letters of intent, but we stopped asking for them because we don't want to upset the FDA. They do not like to see that you are marketing it for sale before it's approved, and they asked us to stop taking letters of intent (the Act says you shall not market and sell your product).
• Deposits for the systems will help us increase our production capability. Currently, there are no plans to raise further funds. If we needed to, we could tap into a credit line in a way that does not dillute share price. Dean has no concern at all about finances.
• We've had conversations with all of the major manufacturers. We've also met with overseas manufacturers to help get ourselves to full production. Can't say we are leaning more towards M&A or partnership. We will move towards production upon approval, but we will certainly continue talks with big players about M&A or partnership.
• For example. we've talked to the head of Toshiba's CT Dept. and they are very interested in our product. Toshiba is so interested because their own device takes 3 or 4 seconds to take the CT slice, and several minutes to create the 3D construct. It is also a large stationary device. Our device creates the construct in less than a second. Application advantages -- Speed (time to acquisition) of 3D construct and Portability.
• About 30 days from approval to have product rolling off the production line. We have the plan in place already. 1 or 2 units per month initially, then hiring people to help sell and manufacture the product. We'll grow at a controlled rate. We have lots of distributors who want to work with us and partner on the sales side.
• Need at least one regulatory body to approve it. When you get U.S. FDA Approval, you are generally good to go in Europe and elsewhere. The U.S. Market is easier to enter and not as many road blocks like customs. Within 6 months, we'll expand into European markets, and then Asia and elsewhare.
• $550,000 for the full product at first, and then we may move up from that number.
• I have relationships with several entities that offer financing for smaller health care markets.
• When we get FDA approval, we can start providing clinical images. We will also start working with Luminary Sites after we have FDA Approval. They have reviewed our product and they will purchase it and they'll market for us.
510K vs. PMA:
• If this was going to go down the PMA route, it would have gone that way already. Dean does not see that as a possibility.
• Worst case scenario from this response is another round of questions, I really don't see the PMA route. The FDA has not even brought it up.
I'm a firm believer in more information is better than less information, but the timing here just has me a little perplexed. If we are really only a week away from submission, I would have preferred to have the call then. If the company was concerned about nervous investors, a call at the end of February (when most were expecting resubmission) announcing that we were two weeks away and that great progress had been made on x, y & z would have been much more welcome than a call now that says we're less than a week away.
Again, I love the product, I love the management team and the prospects for this investment, but I can't say I'm always on board with the public relations / communications strategy. Hopefully, I am pleasantly surprised this afternoon to learn that the submission has been made, and we all watch this thing skyrocket Thursday and Friday, but if it is just a status update and one very close to the end, I will be disappointed. I understand you and Kimble1 are trying to prepare everyone for that disappointment, but I will disappointed nonetheless.
Kimble1, if your projection is accurate, and I am inclined to believe you, do you have any insight into WHY the company would have a conference call NOW to say that we will be resubmitting in less than a week, rather than just waiting the less than a week and having the conference call or press release THEN? Did they feel like things were slipping away and confidence had reached a low point that was about to be irreversible? It just doesn't make any sense to do it less than 7 days before the real news everyone is waiting for. Thoughts?
All this talk about his hands full with his other venture, is just nonsense. He is not running any of these other companies. He's basically just operating a hedge fund... helping to finance these other companies that are being run by their existing management. He may, from time to time, be called on for some consulting about the process, but he is not handling day to day for any company other than Imaging3. People need to relax about that.
Hasn't he alread announced that have obtained space near their current building for manufacturing? Hasn't he already announced that he is arranged for a massive line of credit to which he can tap into to start the manufacturing process? I think he's already announced each of the things you are asking for.
If what you're saying is going to be true, then I expect a very large dip on Thursday, continuing down or steady until a PR or some other announcement that the package has been filed.
The problem is, bashers will run wild with the fact that the Radiologist's review is not complete; i.e., that means they found problems with the images, they don't like the images, the images are poor quality. We will hear that echoing until the report is complete and filed.
To be honest with you, I am very disheartened. If we're really talking about less than a week until it is all done, then I would have preferred to not have this Conference Call until that time. Again, I love the product, I love the company, but I have my concerns about how they "manage the message."
How is it that you are certain? I'm not doubting your or saying that's not exactly how the call will go, but on what authority do you make that claim? Instinct, experience or something you've actually heard from someone who knows.
You think the FDA is paying to fly reviewers all over the country to look at every device submitted for approval? They review data and other information supplied by the company just as they do for drug applications.
I want to know what the radiologist(s) concluded about the quality of the DViS images as compared to the other devices to which the DViS is being compared for purposes of the 510K application.
Honestly, I don't get you at all. You have complained more than anyone about a lack of an update by Dean, and now he sets up a forum on the company's website and schedules a Conference Call to address all of the current issues facing the company and make himself available to answer questions, but all you can do is complain that he's not using a Press Release, which is limited to a few cryptic words that can't be questioned and clarified like he can do on a conference call. Some people will just never be happy.
Personally, I would much prefer the conference call because Dean can go into much more detail, and if he leaves a hole open, it can be filled during the question and answer session.
Because there's more news than just putting a FedEx package in the mail. There's the whole matter of what the radiologist report says and the outcome of his meeting with the FDA review team (i.e., I believe many of the issues/follow-up requests were resolved during that meeting). This is purely positive. If you are long on this company, this call is great news.
"Just going to say that they have submitted the package to the FDA." Just? That's huge news. Remember, Imaging3 is not going to submit the package to the FDA without a report from at least one expert, third party radiologist concluding that the images from the DViS are of at least the same quality as the devices to which the DViS is being compared for purposes of its 510K application. Accordingly, the submission of the package is huge news because it also means we have an official unequivocal endorsement from a professional, independent, expert radiologist. Huge.
Imaging3, Inc. is pleased to announce that on Wednesday, March 10, 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 1-888-732-6202 and enter passcode 745546 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.
A limited number of lines will be available for this conference call. The lines will open up 5 minutes prior to the start of the call.
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.
I suppose it depends on how it's used, but I always prefer more information to less, so if it offers more information, than I absolutely welcome it.
Great post. Thanks.
I agree, official updates from company management would help calm my nerves. I'm not commenting at all on the communication strategy of the company, just commenting about the timing of the submission.
I do, however, think that a lot of this business about Dean looking down his nose at shareholders has been distorted and taken out of context.
Timing of Resubmission:
A lot of people seem to be really worked up about the fact that we are going to miss, by only one or two weeks, Dean's original ESTIMATED projection for resubmission to the FDA by the end of February.
Here's a few things to keep in mind: It was an ESTIMATED time frame. More importantly, it was an estimate offered BEFORE Dean's meeting with the FDA Review Team. Dean identified, at that time, a few unknowns which he said would affect how long it would take to complete the response, including: (1) uncertainty about how long it would take to get images from the comparison devices; (2) what exactly the FDA was looking for (and hence the meeting with the FDA after the conference call); and (3) which radiologist(s) he would use. For all those reasons, I was never banking on the projection. However, we have a new projection, 1-2 weeks from the end of last week. And I have a lot more confidence in that one to two week projection because that projection was made with the benefit of: (1) already having met with the FDA and understanding exactly what they're looking for; and (2) having already worked on the response for several weeks and knowing exactly how close they are to finalizing the response.
Now, Dean has the other images so that's not an unknown anymore. Now, Dean knows exactly what the FDA is looking for because he had a meeting with the FDA review team after the conference call. Now, Dean has already retained two radiologists to complete the review. All this tells me that we should have a lot more confidence in the projection that the resubmission will be made in 5 - 11 days (1 to 2 weeks from late last week) than we ever should have reasonably had in the projection on the conference call made without the benefit of any of these facts.
Regardless, being within a week or two of his original projection in this crazy process, is pretty much nailing it. I'm feeling great again. We're going to get some very good news in the next week or so. Sit back and enjoy the ride.