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There are quite a few "viable excuses" as to why images have not been put on the website, and they have been discussed ad naseum.
This is not like a pdf or a jpeg, or a kid taking a video on his cell phone and putting it on YouTube. We are talking about viewing a 3D image designed to be viewed in a single location... on the screen of the DViS hardware operating with DViS software. 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 images, or to download video or images to some form of public media for public consumption.
I agree, it would be 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 enable high res 3-D images to be viewed in real time on the monitor associated with the device. That fact is, it's a breakthrough software and hardware package that nobody else has, which means you can't just pass it around and view it on some generic media viewer. If Microsoft or Adobe or YouTube had the software that allowed us to view DViS images on a webpage or as an email attachment, then DVIS would hardly be breakthrough, and wouldn't be worth the fortune that it is worth.
At this stage, there is one end game here, and one end game only. That is FDA approval. The more documents the company generates, the more marketing material the company generates, the more images they create, they more the company pumps into the public about the product, the more the FDA has to review. The more the FDA has to review, the more time it will take to get approval. Therefore, there is simply no benefit to be gained by creating a single shred of paper, data or imagery more than what has been requested by the FDA because the more that's out there, the longer the review process will take. Dean has given the FDA what they've asked for, and anything else he does is unnecessary and will cause delay.
Keep in mind everybody, the FDA did ask for ADDITIONAL (not better) images 2 requests for imformation ago. Those images were provided to the FDA and in the most recent round of requests, the FDA did not ask for additional images. That tells me they were satisfied with the images they have been given. They have asked a Radiologist to take a look and compare it to the images of other products, but they did not ask for any more images for themselves. That should tell you something.
In my opinion, Dean would be foolish to start cranking out new materials beyond what the FDA has asked for, if for no other reason than 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 message board posters 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.
The fact us, there are many out there who doubt the usefulness of the DViS. They doubt that it is able to generate images of sufficient quality to be used by radiologists and surgeons for the functions included in the 510K Application. Hence, the cry by many for images to be posted on the company's website. The significance of the resubmission will be that a third party, independent, expert radiologist will have reviewed DViS images against the images from other devices, in various modes and of various body parts and will offer an opinion as to the quality of DViS images as compared to those other devices. Imaging3 is not going to submit a package with an opinion from a radiologist that the images are not of sufficient quality for the device to claim all of the uses it claims in the application. Therefore, when the package is resubmitted, there is a very clear communication to the public that a third party, independent, expert radiologist has concluded that the device works, the images are of comparable quality to other products, and endorses the product. I have no doubt that he will also marvel in his report about the fact that not only are the images of the same quality, but they are generated in live time and with lower dosages of radiation, and therefore, this product needs to be available to the medical industry stat.
The resubmission means that the images are good and the product works. That's why it's going to explode upon the announcement.
Nothing is ever a sure thing, but my point is, he is not "skipping off to a new venture." He is investing in other companies and giving them new advice. He can do that without it interfering with his work at Imaging3, just as I can invest in stocks and chat away on message boards without it affecting my full time job.
Anyone who doubts that Dean is focused on the task at hand, does not know the man. He is focused, he is working around the clock, he is driving his employees and contractors with great determination. He is personally tied into the sucess of Imaging3 more than any other person, so be assured he would not let anything distract him from getting the job done.
Not El Hefe, but here are my thoughts... it sends off positive alarms to me. Dean clearly believes we are at the end of the road here, that the device will be approved by the FDA, and the company will be sold to one of the major players. He posted this on FB page, and I'm inclined to believe him.
Regardless, go to Yahoo Finance, find a list of Board Members, Presidents and CEOs of major companies in America and click on one of the names. You will see one thing consistently, and that is that major business figures in this country are always involved in many companies at the same time. They may be the President of one company and on the Board of 5 or 6 others. That is very common.
For a company like Imaging3 in particular, it makes all the sense in the world. After Dean submits the package to the FDA, what is he supposed to do with his time while he waits for a response from the FDA? There is no manufacturing to oversee. There are no accounts to manage. He will just be waiting. So why not identify the next opportunity in the meantime.
Finally, don't confuse what this business incubator is. Dean will not be running any of these other companies. It is essentially a hedge fund and a consulting firm. He is identifying good ideas and potentially successful businesses, investing capital into them, and advising them on how to succeed. He is not running them, he is not dealing with their day to day operations. It's not much more complicated than what all of us are doing here. We identified Imaging3 as a company that we think will be successful, we invested our capital into the company's stock, and then we play arm chair quarterback on these message boards. I've got another full time job that I'm still able to do successfully. Speaking of which, I'm getting back to work.
Not being defensive, I'm just trying to weigh the relative value of different people's viewpoints. You claim to "know the FDA the way [you] do," which suggests you have some experience dealing with the FDA. I'm just curious what you know about the FDA and how you came to know it, so I can determine what credence to give your posts. I take you don't have any experience with the agency, correct?
Dare I ask, what in your background gives you insight into the workings of the FDA?
Because it's not just a matter of passing paper back and forth. When Imaging3 sends its resubmission to the FDA that means it was able to accomplish all of the tasks requested by the FDA, most importantly, obtain a report from a third party independent expert radiologist to endorse the device. That's a huge deal. It's not the act of submission that will drive up pps, it's the meaning of submission. It means we have that endorsement, and we have been able to address all other issues raised by the FDA.
Don't say you agree with me and the post the exact opposite of what I said. If you think there is going to be a fast and scary decline within 1 week, then sir, you do not agree with me and I do not agree with you.
I'll take that bet. You get the share price the minute before the press release comes out about resubmission, and I get the "over" after that PR. What do I win if I'm right?
The only reason for a prediction of a short term drop in price would be an announcement that we are not close to resubmitting a package to the FDA. People generally expect, whether it's warranted or not (and I believe it is warranted), that an announcement about a resubmission to the FDA will come this week. I can think of no reason whatsoever for a short term drop in pps unless we learn from management that such a response is not going to be made this week or next week.
Frankly, a drop at that point would be shortsighted in my mind, and would just be another opportunity to load up more, but the fact is, there is no good reason to expect a drop.
Within the next couple of days, I expect to hear that Imaging3 has submitted a package to the FDA including responses to all of the FDA's inquiries, follow-up questions and requests. That will include a detailed report from a third party radiologist, who has reviewed images of multiple body parts in multiple modes from multiple devices, including the DViS. His report will conclude that the imagery from the various devices is similar and that the images from the DViS are of sufficient quality for the device to be used for all of the techniques and uses claimed in its application. WIth the buy-in from a third party expert radiologist, the share price will burst through the roof. Likewise, with the buy in from a third party expert radiologist, and answers to all of the agency's other minor queries, I also predict that approval will come quickly, so I disagree with your assessment.
The one question that investors seem to have is whether the images are of sufficient quality to be used by radiologists. When the package goes back to the FDA with the completed report from the radiologist, that question will be answered once and for all. And then the sky is the limit.
Good luck and don't get caught watching the paint dry.
I hope everybody is ready for a big week this week. Strap on your seat belts and enjoy the ride.
Every time somebody yells "Timber!" and says we're heading for the .50's, or .40's or 10 cents, we end up jumping up a dime every day for huge gains. So please, call for me of that, will you.
Don't you think it would be illegal for the company to share that information with a small group of investors? The answers to those questions will come in the form of a PR only. And they will only come when the resubmission is made.
For crying out loud, let me be as clear as I can be here:
1) The timeline was set forth by Dean in the last conference call. At that time, Dean said, as an ESTIMATE, he expected to have a response to the FDA around the end of February.
2) Since giving that estimated timeline, Dean has given public indications that everything is proceeding nicely. Those public indications came in two forms: (i) MoneyTV appearance where he said they were making good progress, had not hid any road bumps in preparing their response, and they were feeling good; and (ii)he reported on his FB page just two days ago that they were making good progress.
3) Dean, who is the only one who really knows about the progress of responding to the FDA, has given no indication in any form that we are not progressing according to schedule.
I never said that on MoneyTV or on Facebook he gave a projected date of resubmission, I said that he gave indication there that things were progressing nicely. If they are progressing nicely, then that means they are "on schedule," which he announced in his conference call to be around the end of February.
The indications are Dean's comments on his MoneyTV appearance and his remarks on his Facebook page. He is the only person that knows the status and his remarks indicate that we are on schedule, and the schedule he identified (as an estimate) was a resubmission around the end of February. I have nothing from anybody that knows anything that would suggest that schedule is not going to be accomplished.
I'm not saying I'm right, I'm saying we haven't even come to the end of Dean's projected time, and all indications from the man that gave that projected time are that things are going well. I just think it's irresponsible to conjure up all these negative scenarios when there's no reason.
"More like the end of March" for re-submission is wrong. Dean projected it would be mid- to end- of February, and he has reported that things are progressing nicely. Sounds to me like a guy that is on schedule. I think end of this week or early next week is quite likely.
The guy is evaluating images of multiple body parts from multiple devices in multiple modes of operation, and then drafting a detailed report of sufficient quality and professionalism to get FDA approval. We were told that the biggest time suck in the process would be getting all of the different images from the competitor devices.
The only word we have gotten from the company is that things are coming along nicely and we haven't even reached the end of the projected time period. There is no reason to be concerned.
Wow, the speculation in there wreaks. How you reach the conclusion that there is a delay, and that the delay is caused by image issues is a beyond me. The only word we have is that the response was expected to go out by the end of February, which we haven't reached yet, and that by Dean's own words, things are progressing nicely. How you jump from that to issues with images, is just irresponsible.
I agree. Sorry if I made that sound like a firm date. I was responding to someone who claimed that it should have been done already. I was pointing out that by Dean's own statement, his projected time frame has not even run yet. Thanks for clarifying.
You are mistaken. Dean, in communication with the FDA, set forward his schedule, which was a response to the FDA in mid- to late- February. This week is right when we all expected his response to go back. You often claim to have listened to his calls, but you seldom can remember anything that is said during them.
It would be illegal for the CEO of a company to take actions to deliberately keep the share price of his own company down.
They also have revenue, and cash burn rate went down after RSNA.
You don't have to hold your breath to find out. You are wrong.
They do have some revenue, too.
If that's what he's saying then he's completely wrong. Dean said they had more than enough cash to carry all the way through 2010, and then they had access to a credit vehicle that would carry them through at least 2011. This whole cash crunch was made up out of thin air by you today.
Well, if you ignore 80% of my post, then I suppose it does seem unreasonable.
Salaries, cost of responding to the FDA, preparing for manufacturing, and the rest of the business they run (the C-Arm products, etc.).
That's a pretty small number.
He has already confirmed that he had the call with the FDA. It was at least 3 weeks ago.
Why is it difficult for you to believe? What are the major cash expenditures right now? We are just waiting for an FDA approval process to play out. It's not like we are manufacturing products that are sitting on the shelves. We've got rent, a few employees, and postage when we send information back to the FDA.
R&D is done.
During the last call he gave a complete accounting of the company's cash on hand, burn rate, plus he identified a credit vehicle the company had already obtained, but not accessed (i.e., cash that was available but not yet tapped into). He confirmed that the company would be fine for at least 2 years with the cash and credit it had on hand, to say nothing of the numerous other ways to generate cash flow (loans from Dean, sell more shares, etc.).
In sum, there is no cash concern.
What in the world has changed? He knew the cash burn rate and he knew the cash on hand and the value of the credit vehicle. Your agenda here is transparent.
He gave the precise number and identified a major source of credit on top of that. I do believe what the CEO of the company says to the public in a conference call. If he was lying, he would go to jail. Wish the same were true of the people on this board. And I'll take your bet. Name the amount and you're on.
Enough already with the bogus doomsday cash is running out story you've been fiddling here. In the last call Dean said Imaging3 was fine from a cash standpoint for at least 2 years. Take this nonsense back to the Yahoo Board.
That is not true. The FDA asked for "additional images" not "better" images. I.e., images of other body parts and in other modes to confirm the DViS can be used in all the ways it claims in the application.
Hilarious that you're talking about honest information.
I'm sure what he means by "good information" he means reliable information, not positive information.
Why are we thanking someone for spreading misinformation repeatedly, even after it's been demonstrated that the same misinformation he spreads over and over again is false. Take for example his repeated claim that "Dean did not take good images to RSA." That is just a lie, plain and simple. There are some things that Borntwice writes that you could almost read as confusion or just misleading, but this one that he repeats is a flat out lie and he knows it.
Dean said that he took the same images to the 2009 RSA that he took to the 2008 RSA. He did not say they weren't good images. In fact, he said the exact opposite. He said they were excellent, attendees at the RSA raved about them, and because they were of such fine quality, there was no need to create any new images.
By repeating that lie and others, Borntwice does not contribute to the discussion on this board in any meaningful way. I'm not saying, of course, that someone with negative thoughts about the value of the company don't contribute to the discussion, I'm saying that the spreading of lies does not contribute, and that is Borntwice's game. He should not be thanked for it, and frankly, in my opinion, when something he says is demonstrably false (which is most of what he says), it should be removed.
You're ignoring the fact that if Imaging3 has a valid patent, competitors are prohibited by law from selling an infringing product. It doesn't matter if they spend trillions on R&D to develop a product that does the same thing... the second they sell one of them, they infringe on Imaging3's patent, and all the profits go straight to Imaging3.
Regardless of the NDA, that would be a violation of the patent.