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Wow. Just, wow.
Come on Hawk. We were at the labeling stage with the previous reviewer. Had that reviewer not been replaced we would have been done and approved last fall. As fate would have it, there was an election, a new team one, and the Administration changed over, including an entirely new CDRH review division from top to bottom. The new reviewer was not going to rubber stamp the work of the old reviewer, especially since that entire group was run out on a rail. We got 17 questions and a request for a review along with a promise that those questions reflected the universe of subjects about which the new reviewer had questions after an exhaustive review of the entire application package. Since that time, there has been some back and forth about minor inquiries (mostly about the unusual information requeuested by the previous reviewer). Also since that time, the new FDA has started to do an amazing thing that the old FDA couldn't manage to do... meet their own internal goals, nay, exceed their internal goals. All very positive signs.
BT, I agree that the best due diligence is to listen to what is coming directly from the horse's mouth, but I think you're looking at the wrong horse, or at least not all the relevant horses. Unfortunately, the fate of Imaging3 is not entirely in Dean's hands right now. In large part, the fate of Imaging3 rests in the hands of the FDA. So how could you do complete due diligence without looking at what the FDA is saying? That's why the FDA's quarterly reports about their own efficiency in responding to 510(k) applications is as critical to Imaging3 as anything that Dean says on conference calls.
Seriously? You don't see how anyone can find the FDA's new more expeditious resolution of 510(k) applications as a positive thing? That's a real head-scratcher.
That is what I think but stranger things have happened. I wouldn't put it past them to come back with another request, but I agree that because we have gone this deep into the review cycle, all the while fielding minor informal requests, that we are likely due some very good news.
Agreed, except for the 98%. They are meeting their goal of responding withing 150 days 100% of the time in 2010. Even more reassuring.
It doesn't take much effort to go to the FDA's website and check for yourself, but I suppose it's easier to just sit back and fling mud. For what it's worth, the more relevant inquiry would be the average review time for radiation emitting Class II devices, not just all 510(k) applications. An even more appropriate inquiry would be the average review time of radiation emitting Class II devices when the application spans a change in the Administration and a complete shake-up at the FDA (in part due to issues related to radiation emitting devices). I think you'll find that it's no cake walk. But again, I have to ask what value your one liners and insults are adding to the conversation? We are where we are, and what happened with a different Reviewer and a different FDA is meaningless. We are dealing with a reviewer and an FDA now that are getting responses back within 150 days 100% of the time, and we are approaching 150 days since our last submission in response to a formal request (11 trading days). That's called DD. What can your contribute?
What exactly is the DD you have provided? You just pop in from time to time to drop a meaningless insulting one-liner about Dean or the Company, insult other posters, and add absolutely zero substance to the discussion. If you're going to come in here and call me a liar, I'd ask you to point to a single thing that I have reported as a fact (as opposed to a prediction of an unpredictable future event) that has been proven to be false. I also deeply resent your implication that I'm paid by anybody to do or say anything. I'm a long term investor in Imaging3 and I come here to share my due diligence with other mature adults. Please do the same or keep it to yourself.
Very useful. Thanks for sharing your DD.
Low volume because nobody is selling. I've had an order at .27 all morning that won't fill. Come on all you naysayers, let me have your shares.
Sorry for the confusion. I don't know when the new FDA team took over NEPH. Perhaps someone could pop over to the NEPH Board if there is one and ask the folks over there if they know. I only know that we got a new team in late fall 2009 and that it was part of a major overhaul at the FDA. Presumably NEPH was in the same boat as Imaging3 because the entire review division of the CDRH was shaken up from top to bottom. The January request we received was the 1st request from the new team. They took over the application in late fall, and got a formal AI request back to Imaging3 within 90 days with the first formal AI Request. We responded and are now on the verge of 150 FDA days since the response.
I don't know the history with NEPH. In particular, I don't know when the new review team took over, but I do know that a new review team had to have taken over, because the old reviewers were replaced. When that happened specifically, and what communications they had with NEPH after taking over, I'm not sure of. But it makes sense to me that the FDA is not counting the long history before the new review team took over.
It goes a little bit deeper than just the "goals" reported at that link, marysawa. At the end of every quarter, the FDA holds a meeting to report their Quarterly statistics against their Performance Goals. Here is a link to the last quarter's performance against the goals by the CDRH, the division of the FDA managing the DViS application:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM212876.pdf
You can see that they are actually exceeding their 98% goal within 150 days by getting them all (100%) done within 150 days.
With respect to those that appear to have gone longer, NEPH for example, remember that every applicant who submitted a 510(k) application to the FDA under the prior administration was in the same boat as Imaging3... victims of the total turnover at the FDA. The NEPH application was handed over to a brand new team at the FDA mid-stream just like the DViS application. Accordingly, NEPH's new FDA team, which took over the same time as the DViS review team (late fall 2009) did complete its review of the NEPH application in much less time than 150 days. They already have their answer.
Buy at .15. Sell at $3.75. Retire.
Actually, I was refering to Shaka's inquiry about whether the Company was selling shares. By the Company, I assume he means either Imaging3 or its officers and directors. Here was his quote: "I wonder if the fall to .15 was due to the company selling shares. Or was the CC an opportunity for the company to sell shares into a small runup? It would sure be nice to know."
He wanted to know if "the company" has been selling shares, and I showed him exactly where to look to see that, in fact, the Company is NOT selling shares. There can be no reasonable debate about whether the Company was or is selling shares. Dean said they're not, there have been no SEC Form 4's filed and there has been no other public report of any Company sales. Case closed. Next?
Then why in the past, and I mean 2 years ago past, when Dean did sell some share, did he file the Form 4 and publicize his sale? Perhaps it's because he's an honest, up front businessman. Perhaps it's his military background. Perhaps it's because he follows the law. I'm not naive, I just look at the facts, and the facts show me that when Dean transfers his shares, he files the Form 4 within 2 business days, as the SEC requires.
Of course I see that the SEC and FDA are relevant agencies to Imaging3. What I don't see is whether the SEC using an evergreen or an la carte process makes any difference to anything that will affect shareholders. Enlighten me.
So in other words, you can't refute it. I didn't read anywhere that new packets restarted the clock. In fact, restarting the clock has absolutely nothing to do with the content of the submission and 100% to do with the form of the request and whether the request is made by a formal written AI request letter or followed up by a formal written "hold" letter. Since neither of those apply, the clock does not restart. It's as clear as can be.
I have offered no commentary about the SEC process, as that is not within my expertise. You will have to check with an SEC attorney about that. I'm only describing the FDA 510(k) application process, which I do have experience with.
But again, what difference does it make?
I know a lot of people on here and otherwise who bought in with the PPM, and none of them has ever met Altounian. I have had more than a few communications with management at Imaging3, and not once has anyone mentioned Altounian or suggested that they needed to check with him or get his approval to do or say anything. Imaging3 has been around for more than a dozen years and not for one second of that time has Altounian been an employee, manager, officer, director or consultant to the Company. Altounian didn't invent the DViS. His name is not on the patent. His name is not on the 51o(k) application. And anyway, it's not like the guy is some kind of criminal for which any guilt by association even makes sense. He's a businessman who has held management positions at various companies, none of which were in the medical field. He is so utterly irrelevant to the discussion of FDA approval and Imaging3's future success. It's time to give that a rest.
What's the point you want to make, Hawk? Based on my own experience with the FDA, subsequent submissions following formal AI requests include the full history of the application along with the new information requested. The application grows throughout the process.
Now let's assume for a second that I just made that up completely. So what? What is the point you're trying to make?
Now assume that I do know what I'm talking about. Again, so what? What difference does this make at all?
I know how the FDA process works. The SEC process apparently also works like that, as Dean described, but that is how the 510(k) process works, based on my experience.
3 years, not 4. I think the original FDA Reviewer was a little crazy, and guess what, SO DID THE FDA... they fired her and replaced her with a new Reviewer. And guess what, the new Reviewer also thought she was crazy, as his numerous questions about why she asked certain questions demonstrates. It's a shame we drew the short straw and got stuck with her, but Dean battled that adversity to the brink of approval with her right before she was fired. Since we got the new Reviewer, our timing is 100% consistent with every other CDRH review out there... less than 150 days with approval imminent.
Let me ask you a serious question, why do you keep saying 4 years? You have more than enough legit complaints you can make. 3 years is still a long time and enough to concern a lot of people. So why do you say 4 years, when you know that it's been 3 years and a few days?
Can you please explain what rationale you have to explain why the FDA's review clock restarted on July 5th, including a specific refutation of the facts set forth below. Start with the FDA's own guidelines for how it manages its own review clock: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089735.htm that provides the exact opposite of what you are saying. In this link you will find the FDA's explanation for "Formal AI Requests" vs. "Informal" requests and what impacts those requests have on the FDA's review clock. Here are the relevant excerpts:
_________________________________
a. Request AI by letter ("formal" AI request)
A request for AI by letter refers to a request made (1) directly by letter or (2) first by telephone, fax, or e-mail, AND THEN FOLLOWED-UP WITH A LETTER INFORMING THE SUBMITTER THAT THE 510(k) IS BEING PLACED ON "HOLD" PENDING RECEIPT of a response to all of the identified deficiencies.
b. Request AI by means other than letter ("informal" AI request)
An informal request for AI refers to a request made by telephone, fax, or e-mail, and not followed-up with a letter. AN INFORMAL AI REQUEST DOES NOT RESULT IN THE 510(k) BEING PLACED ON "HOLD."
* * * * *
2. Effect on Review Clock
Informal AI request
An informal request for additional information does not stop the FDA review clock because the 510(k) remains under review.
Note: If FDA does not receive industry's response to all of the deficiencies in the informal AI request within the agreed upon time, FDA MAY ISSUE A LETTER PLACING THE 510(k) ON "HOLD" TO STOP THE CLOCK.
3. Effect on MDUFMA Goals
Informal AI request
This 510(k) action has no effect on the MDUFMA goals because this action does not affect the review clock.
____________________________
Frankly, it couldn't be much more clear in the FDA's guidance. Absent a formal written hard copy letter that notifies the submitter that the review process has been put on "hold" the review clock does not stop. Absent a formal written AI Request, the clock does not stop and restart. Dean was asked as clearly as could be on the last conference call whether he had received any formal letter requests for AI or any written "hold" letters from the FDA since the April submission, and he answered just as clearly that he had not. Whatever anybody thinks about the "review clock" in general, there really can't be any reasonable debate as to whether the clock stopped and restarted in July. No Formal AI letter and no "hold" letter means definitively that the clock didn't stop or restart.
How do you justify your theory that the clock did stop and restart in July?
I'll ask, although I expect the same response as always, which is to say, no response at all: On what facts do you base your prediction that we will not hear from the FDA until the first week of October? Is that just your gut or is it based on any due diligence whatsoever?
Are you aware of bunches of other 510(k) applications that took 180 days from the submission for a response? Do have some data on average response times of the FDA that reflect 180 days? Do have a link to some percentages of responses received after 150 days but within 180 days? Seriously, we have posted a lot of concrete data to support our prediction that we will hear by Sept. 8. What do you have? Or is this just your hope that a prediction of 2 more months from a guy who once owned 2 million shares and who made well over $1 million from this stock will cause the price to drive down low enough for you to buy back in?
I don't understand the question? It's evergreen in the sense that it lives a long live throughout many changes and many different questions and requests from the FDA. When you submit in response to an AI Request, you don't submit just a few pages that respond to the specific questions, you submit the entire application with the new information incorporated into the application. Perhaps "evolving" document is a better descriptor than "evergreen." The application grows as new questions are asked. So the new Reviewer saw all the old information that was included in addition to the new information he requested.
"Scrathing the head" is a figure of speech. He was confused as to why certain data was in there, and when he heard that it was in response to requests from the old reviewer, he was confused as to why those questions had been asked, because, it turns out, they were not the sort of questions that would be appropriate for this application. Of course, that was Dean's frustration all along, and why the process was being delayed so long. Then there was the changeover of the review team (and really the entire agency), which necessarily added more delay. And now we are right at the end of a normal review period. If we hear by Sept. 8, I'd say the new Review team nailed it with dispatch.
Dean and Mike have explained the head scratching. It's why Dean submitted the annotated application in July... to explain which data sets were provided in response to the old reviewer's questions, as opposed to being provided because they were actually necessary or appropriate for a 510(k) application. Dean detected a trend in the questions that the new Reviewer was asking, and the trend was: "why is this included in your application?" Since the answer was the same each time, "the old Reviewer asked for it, for whatever reason," he decided to send in the annotated version to cut off those questions; i.e., identify which pieces are only included because the old reviewer asked for then, so the new Reviewer doesn't need to ask why it's there.
Does that answer your question?
I love it. That's as good a basis as any for an approval prediction. I'm putting my money on next Tuesday and on your birthday. Either sounds good to me.
What the new Reviewer was asking is, why in the World is this data included, and when Dean explained that it was included because the old Reviewer asked for it, the new Reviewer scratched his head in bewilderment at how crazy the old Reviewer was. That's why I'm blaming the FDA... the Old FDA. They were way out in left field, asking for a lot of stuff that didn't make sense, and that has been validated by the new Reviewer.
The 510(k) application process is evergreen. You don't ever take material out, you just add to it. The new FDA Reviewer did not start "from scratch," he started from the beginning, doing a comprehensive review of the entire application to identify any subject about which he might have a question, which generated the 18 questions. Most of those were repeats. Many were addressed by phone AND by inclusion in the updated application submitted on April 5. The application constantly evolves as more questions are asked. Redline versions are provided. New data packets are added. New files are added. But the old files are not deleted or removed. The application just continues to grow, hence it is now thousands of pages.
No, Kimble, I've been looking for the other Company that has posted on the internet a live video demonstration of a medical imaging device prior to receiving 510(k) approval from the FDA. As much whining as we have heard for Dean to do it, nobody has been able to point to a single example of another company doing it. I'm still waiting.
That's a great point, gdsgds. You are not the CEO of a publicly traded company, but Dean is. That means he is regulated by the SEC, so every time he speaks, he is under oath. If he lies in a public statement about his Company, he commits a crime, because he is the CEO of a publicly traded company. That's why we can believe what he says. Posters on this Board are not regulated by the SEC, so their word is less meaningful than Dean's. You asked for Dean to state under oath that the live 3D works, and he just did that last week. On a conference call announced by a public PR, he swore the live 3D works, and as an SEC regulated officer of a public company, that statement was a sworn statement. So he gave you exactly what he wanted. End of story.
Hmmm, 5 x 30 days = ?
BT, your analogy fails because the internet is not the Salt Flats. The internet is wide open for everybody and anybody to see, including those that would issue you a ticket for speeding. I can't drive it over 600 mph because I could get in trouble for doing that if the authority that controls that can observe me doing it. Well, the FDA can observe a video demonstration that goes out over the internet, so he can't take the machine up to 600 mph, because that might cause them to come back with another round of Additional Information requests, which could in turn result in a 6 month delay. Is that what you want? For piece of mind NOW, instead of 3 weeks from now, you would gamble a 6 month delay? That is crazy.
JB is not suggesting that the theory or question, no matter how absurd it is, should not be aired on this message board. What he's saying is, is it really necessary to post, repost and repost again 15 times within an hour the exact same absurd theory or question? It's a reasonable point. It's almost as though the point is not to have the question answered (as it has been answered hundreds of times), but to try to plant some sort of doubt in peoples' minds for some other personal motive.
BT, it is absolutely lie to attribute to Dean a statement that if showed a video the absolute most that could delay the process is 2 weeks. Lie! He said that even if it delayed it JUST 2 weeks, that would be 2 weeks too many and an injustice to all the shareholders. There is no way to predict the kind of delay it could cause. In fact, it could generate another round of a formal AI request, which could delay the process by the length of time it would take to put together the response + another 150 days. That would be a killer to the PPS and the long term profitability of the Company. That's why it would be incredibly stupid to put up a video showing the breakthrough aspect of this device. The FDA was fine with him showing what he showed, so there was no risk there, but there is huge risk of major delays if he puts up more. He did not say that the max delay would be 2 weeks, he said even if it was just 2 weeks, that's too much of a delay. If you can wait a 2 week delay to see the images, why can't you stop complaining for 3 weeks until we have approval and then you will get your demonstration. It's JUST 3 weeks.
We actually do know more about what was in the reports now than we did before Dean's most recent Conference Call. Now we know that both of the third part, expert radiologists confirmed that the images were in fact, substantially equivalent to the images from the predicate devices, and that at least one and probably both, said the images were superior to the images from the predicate devices. We also know that both radiologists were not Imagin3 shareholders, but after reviewing the device, wanted to rush out and buy shares.
BT: <Why can't he say he has a working device? IS there a law against this?>
You're kidding right? Didn't you watch the video? Didn't he say as clearly as can be that the device does function in all its modalities right now? Didn't you hear that? Why do you say things that you know are not true?
BT: <The FDA has already sent it back numerous times over teh last couple of years and it worked then as well. But it didn;t work good enough..>
Again, this shows a lack of understanding of the FDA process. The FDA has not once come back and asked Dean to make any changes to the performance of the machine. Every request has been about establishing Substantial Equivalent to a prior approved predicate device. E.g., clarifications of wording in manuals, the application, the label, the intended use statement to confirm that the device would be used in the same way as the predicate devices, for the same procedures, etc. Confirmation that the device is as safe as the predicate devices, e.g., provide the data from the vibration tests that have been performed, demonstrate that it operates in the acceptable radiation range, etc. Provide an analysis from a Radiologist to confirm SE of the images. There has never been an issue with the device "working good enough." It's just a process of establishing SE, and it takes time. We're there now and we'll have our word in the next 3 weeks.
I assume you listened to the call. I assume you heard Dean explain as clearly as can be that the machine works right now. I assume you heard Dean explain as clearly as can be that the machine captures and displays 3D images in live time right now. I assume you heard Dean explain as clearly as can be that at least two different third party, expert radiologists, who reviewed those images confirmed that they are, right now, substantially equivalent (indeed superior) to comparable images from predicated devices. I assume you heard Dean explain as clearly as can be that as soon as the FDA approves the device it is ready to be rolled out the door, sold and put to work on patients right now.
Why do you keep asking silly questions that have already been answered. My answer to your questions is NO, there is no chance that this is just a concept for which the technology has not caught up, because we know that the device is working right now and performing all the functions that Dean has said it is capable of performing right now.
If a tree falls in the woods and there's nobody around to hear it, does it make a sound? Of course it does. It's basic science.
Way to go Shaka, you spelled "king," right. Did you look it up first?
Again, not bragging and not saying I'm "happy with a .26 stock price." I'm just calling you out on a totally bs claim that a double is a dead cat bounce. You and I both know that's not what this is. I'll be happy at $5.