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I am saying it is marketing, and have said it over and over. Do 10 seconds of due diligence on this Board and you will see the links where the FDA prohibits marketing of pre-approved devices. It's crystal clear and the evidence of that is in the fact that not one single device manufacturer is out there is doing it.
I do continue to load up. PPMs are generally offered at a discount because of the temporary trading restrictions attached to them, so if I could get even more discounted shares, I'd take 'em in a heartbeat.
Again, as soon as you can show me a single other major device manufacturer that posts on the internet a video of a live demonstration of a pre-approved radiological device, I will take up the cause to get Dean to follow suit. However, despite all the wrangling and whining about it, nobody has been able to link to a single live demonstration by any other Company of an imaging device that is not yet FDA-approved. Don't you think there's a legit reason that literally not a single other company does this? Show me a link and I will take up the fight to get the Company to do it. If you can't, then leave it alone.
I know I would. A lot of people sure jumped into much more shallow water at the .02 and .03 level with the same promise of FDA approval that we have now. I can't see why they'd shy away at this level. Anyway, I know I would, and I'm sure there are others out there, too.
Then please explain to me why they have not even issued any of the 125 million shares that are currently authorized but not issued? If they are so desparate to start issuing new shares, why have they not touched those?
Shaka,
Honestly, it doesn't take much to look at the facts before you say something so completely wrong. It's hard for me to see things from the perspective of a non-regulatory attorney, because that's been my life for so long now, but the facts about the FDA process have been posted so many times that I can hardly understand you making a statement like that, that is so contrary to the facts.
FACT: An informal AI requests "does not affect the review clock." That is an irrefutable fact. It is not up for debate. It is plain as day on the FDA's own website.
Straight from the FDA's website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089735.htm
Request AI by letter (formal AI request):
FDA generally requests AI by letter when the agency believes the additional information is not minor in nature and/or cannot be provided within a reasonable period of time (i.e., such that the review will not be delayed).
Informal AI request:
FDA generally requests AI by means other than a letter when the agency believes the additional information is relatively minor in nature (e.g., a simple change to the device's proposed labeling) and can be provided quickly. Such requests are generally made when FDA believes the submitter can address all of the information requested within a reasonable period of time that will not delay the review and the reviewer receives the 510(k) submitter's commitment to providing the AI by the agreed upon time.
Effect on Review Clock:
a. Request AI by letter (formal AI request)
A request for AI by letter is an interim action that stops the review clock and marks the end of an FDA review cycle. The FDA review time for this 510(k) action is the number of FDA days for the review cycle. The review cycle begins on the date FDA receives the original 510(k) submission (or supplemental submission in response to an AI request letter) and ends on the date FDA issues the AI letter.
b. 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.
Effect on MDUFMA Goals:
a. Request AI by letter (formal AI request)
In accordance with the Goals Letter, to meet the MDUFMA decision goals, requests for AI should issue as early as possible in the review cycle so that the cumulative number of FDA review days does not exceed 90. In accordance with the Goals Letter, to be counted as meeting the MDUFMA cycle goals, FDA should issue the first AI request letter within 75 days from the date the original 510(k) submission is received or, for a second AI request, within 60 FDA days from the date of receipt of the submitter's response to all of the deficiencies identified in the first AI request.
b. Informal AI request
This 510(k) action has no effect on the MDUFMA goals because this action does not affect the review clock.
* * * * * * * * * * *
So its established that an Informal AI request does NOT affect the review clock. What about a submission by an applicant in response to an Informal AI request? That also does NOT affect the Review Clock. Again, straight from the FDA's website:
Effect on Review Clock:
Industry's submission of a response to an informal FDA request for AI is an action that does not affect the review clock because the 510(k) remains under review while the request is pending.
Note: If the agency does not receive industry's response to all of the deficiencies within the agreed upon time, FDA may issue a letter placing the 510(k) on "hold" and stop the review clock.
Effect on MDUFMA Goals:
Industry's submission of a response to a FDA informal request for AI has no effect on the MDUFMA goals because this action does not affect the review clock.
* * * * * * * * * * * *
As you can plainly see, it is "ignorant" to think that no matter what, any change to the application restarts the review clock. It doesn't matter what changes are made, it only matters whether the changes were made pursuant to a Formal AI Request letter, or if the request was followed by a Formal "Hold" letter. Neither circumstance applies here, so clearly the clock did not restart... and it's "ignorant" to think otherwise.
You were dead on.
We know that it is not one of the predicate devices in the DViS 510(k) application. I believe the two devices that are identified as the predicate devices for the DViS have been posted on this Board, and this was not one of them.
Very true, Martin. The FDA either sends a formal AI Request, which automatically restarts the clock, or they send a formal letter following an email or telephone request announcing that the application review has been put on "Hold" and/or they intend to restart the review clock all together. Clearly the July 5th submission did not follow a formal AI Request, as it did not follow any request at all (it was a proactive step initiated by Dean on his own, not the FDA). Likewise, had the FDA sent a Hold letter or a Restart Letter, Dean would have announced it publicly just as he has every other time he has received a formal notice from the FDA. Rather, Dean said he expects it to fly through now, which suggests the exact opposite of restarting the clock. Kimble's "Feelings" notwithstanding, the FACTS clearly support that the clock has not restarted and the application was not even put on hold.
It is absurd to suggest that the July 5th submission restarts anything. FDA only restarts its clock following a formal Additional Information Action Request. Not only did the July 5th package not come as a result of a formal AI Request, it did not come as a result of any request from the FDA at all. Dean detected a pattern in the questions from the Reviewer during their regular informal interactions about the application. Particularly, why did the DViS Application include certain information and data that would not typically be included in a 510(k) application. The response to each question was the same, the previous Reviewer (who had been fired because she was known to be a disaster within the agency) had asked these off the wall inappropriate questions and requests. Because this question kept coming up from the new Reviewer, Dean took it upon himself to send the new Reviewer on July 5th an Annotated version of the same application package he had provided on April 5th, identifying which sets of information were included solely because of the bizarre questions from the previous Reviewer. For those of you who are intellectually challenged, annotated means that he attached a detailed Table of Contents with a road map of cross-references and notes.
There is absolultey zero chance that a submission like that restarts the clock. The FDA didn't ask for it so it clearly would not be a trigger for restarting the clock.
Yep.
You posted, and I quote: "If you cannot get the format correct, . . ."
I am correcting, yet again, the misinformation campaign that Dean either didn't know the proper file format or was unable to provide the proper file format. That is wrong. There was a typical government IT issue opening a file that tested fine on Imaging3's end and was sent in the same typical imaging file format as all the other images that the FDA was able to open. And let's not forget, people, a hard copy accompanied the submission, so it's not like they couldn't see everything the entire time.
What is your basis for claiming that we won't hear back until the end of September? 150 days is up Sept. 8, and they meet that mark 98% of the time. 90 days has already passed. I would say it's any day now, with an outside mark of Sept. 8.
I am fully aware of what they have filed. I am fully aware that they had included in a filing a proxy vote for the authorization (NOT ISSUANCE) of shares up to 750 million. As of now, there isn't even a date set for a vote on that proxy. In that same notice that you linked, Dean explained the reason for the request for new authorized shares, and the reason was to use as a poison pill in the event of an attempted hostile takeover... i.e., he expressly stated that they do NOT intend to issue the shares. Rather, they just want to have them authorized in case they need to prevent a hostile takeover. That motivation is fully supported by the fact that he is already sitting on 125 million authorized shares that he has not issued in the past year. So if he wanted to issue more shares, he could, even without that proxy vote that isn't even currently scheduled. So for you and AT to talk about how they want to issue new shares, without confirmation from the Company, is a leap in logic that is totally not supported by the Company's filings, the CEO's public statements and the current state of affairs.
You can either take my word for it or don't. I don't really care what you want from me in the way of support. However, until a single fact that I present on this Board is proven to be false, you disagree with me at your own peril. I've been wrong about predictions of things that will happen in the future, but I have not been wrong once about a statement of fact.
How do you know what they "want" to issue? They are authorized to issue an additionla 125 million shares right now, and have not issued them... so why do you think they "want" to issue any more? Dean already explained that he wanted to new shares authorized as a poison pill; i.e., he will NOT issue them unless he needs to to prevent a hostile takeover. I think that motive is fully supported by the fact that if he really wanted to issue more shares, he could do it right now... he could issues 125 million more shares right now if he "wanted" to, and hasn't done so for over a year.
You're the one making a claim about something that has not been reported anywhere by anyone. Why don't you confirm your facts? If the Company was going to issue more shares, why, over the past year, have they not issued a single new share that they were already authorized to issue? They are sitting 125 million shares that they are authorized to issue but have not issued yet. If you are so certain that they are going to double the size of issued shares, why haven't they touched those yet? Why don't you answer the question?
There were no issues with Format. I repeat, Dean did NOT send any wrong file type to the FDA. They had issues opening a couple of files due to typical government IT issues. The exact same file type / file format was sent back to them and they opened fine. There was no mistake by Dean in sending a file type not supported by the FDA or a file type they did not want. Sometimes, files don't open. It is a fact of modern technology. It happens all the time. Repeating that he sent the wrong file type doesn't make it true... it just repeats a falsehood.
I didn't realize Dean was the CEO of every company that has submitted a 510(k) application for a radiation emitting device in the past two years, because they are all up in arms about how the FDA is killing their industry with massive delays in approval of radiation emitting devices. I guess Dean owes an apology to the shareholders of those hundreds of other companies, too, since it's obviously not the FDA's systematic problem, but Dean's mismanagement of all those other companies.
375 million shares are issued, despite being authorized to issue 500 million. It has been about a years since the Company last issued a single share, which it has been authorized to do that entire time. It is not authorized to issue up to 750 million shares and does not even have a vote scheduled for which that would even be an option. Give all of those FACTS, how is it that you are "certain" they will be issuing twice as many shares as are outstanding right now?
A good suggestion. Thanks.
Perhaps, but if it turns out that I'm right, as I have been 100% of the time with respect to questions of fact (admittedly I've been off in my predictions of the future), then you may want to reconsider. I'll share what I think I know, if you all do the same, but don't attack me, don't taunt me, and I'll return the favor. Let's take a look at some things that I have reported as fact in the past, which were challenged by others:
(1) the 510(k) application includes cardiac procedures. A fact confirmed by Dean.
(2) the Radiologist Review was completed and included in the April 5 submission. A fact confirmed by Dean.
(3) the Radiologist Review included reports from at least 2 radiologists. A fact confirmed by Dean.
(4) Dean was in regular communication with the reviewer after the April submission, and was addressing minor questions and requests by phone and email. A fact confirmed by Dean.
Etc. etc. etc.
You clearly either didn't listen to anything I said about how to conduct yourself if you really want an answer or your are incapable. As such, don't hold your breath waiting for a response. Others, if you want an answer, and you're capable of being professional, respectful and mature, give it a shot. Call, be a grown about it, and ask your questions.
And exactly who did I call a troll? I said, you're more likely to get a response if you act professional, not like a troll. Who was I calling a troll?
Thankfully I've never said any of the things in your post or anything like that. I'm not sure how to be any more clear than to tell you to do your own due diligence, just as I've done.
I don't understand why you're reading any of my responses as harsh. You asked if I'm suggesting that you call the Company to ask the question, and I'm answering you, yes. That's all I'm saying.
I wasn't really directing that "lecture" at him, but more so to the others on the Board who ask questions for which they already know the answer or don't really want an answer; they just want to stir the pot. All I'm saying is, if you have a question that you really want answered, and it's a question to which the answer is not material information (i.e., 8K type of information), you can get it answered by the Company if you treat them with respect, and you conduct yourself with professionalism and maturity. There is no veil of secrecy over there. They are a very open group of people
I'm saying that a lot of people ask a lot of questions on this Board that if they really wanted the answers to those questions, all they have to do is contact the Company and ask. It's not insider information, it's not a material event, so the Company will probably answer your question about how many files couldn't be opened, and whether it was a file format issue or just an IT issue. That contact information is there for a reason.
I can't say for sure, but I have heard it reported here that Dean did confirm with the FDA that they were able to open everything now, so I assume that means yes.
False false false! He has successful 510(k)'s under his belt at the predecessor company to Imaging3, his Company. Where do you get your info from? You're just flat wrong.
Enough of this line of bull that Dean sent the FDA the wrong file format. That is flat out false. Dean sent many image files, all of the same file format, and all but two of them opened fine. This was not a file format issue, this was a run of the mill government IT issue. They couldn't get two files to open... they were the right file format, and they worked when they were tested at Imaging3 before sending them to the FDA, but when the reviewer went to open the dozens of imgage files they had, a couple wouldn't open right. It happens all the time. Stop saying that Dean, like some sort of idiot, sent them the wrong file type. That's not what happened. It was immediately corrected, they can open all the files now. It's irrelevant to the amount of review time the FDA has taken.
What is this Metronics you keep writing about? I'm not aware of any such entity.
And he did provide the images, many of them.
So if he could take an action today that would drive the share price up 10% for 1-day, but cause the Company to go bankrupt the following week... it would be his duty to do that b/c shareholders could "profit" by selling after that 10% spike? NO! His job is to make the business a success, generate REAL profits for the Company (in the ledger not your brokerage account), and to march the PPS up in the long term, not the short term.
He is trying to get the product out. That's the whole point of this. You are asking him to do something that jeopardizes that. I'm not interested in a 20% return today. I'm intersted in a 2000% return after FDA approval / M&A. If CEO's acted with only the short term in mind, there would be a lot of CEO's sitting in jail and ruined by derivative suits.
Dean is not "in stocks." Dean is the CEO of a Company, whose mission is NOT to drive up the PPS in the short term at the expense of overall business success. His job is to operate a successful business for the benefit of the Company's shareholders, not in the short term, but overall. Dean, many others, and I agree that marketing the device at this time, being against the law and the direct instructions of the FDA and all, absolutely could jeopardize FDA approval. While it would no doubt have a positive effect on the PPS in the short term, it could ruin the Company, because the Company's success is derived 100% from FDA approval of the DViS. He would breach his fiduciary duty to his shareholders if he took an action that jeopardized FDA approval, and that's exactly what you're asking for.
Missing the forest for the trees, BT. What you're saying is, it's ok if we push off or even jeopardize approval, so long as we can get a small short term spike in PPS? That is an ignorant strategy, and one that I do not endorse at all.
Bigbreak, you have proven yourself to BigWrong with every prediction you have made lately. .26 2 days ago... instead we were green. Approval by 8 PM yesterday. Nope. .10 in 10 days, not even close. What's your newest prediction that we can completely ignore?
That was awesome. That video, entitled "GE MR 360 Product Launch" was put out when they launched the product; i.e., AFTER APPROVAL, which is exactly the type of public marketing and displays of the DViS that I fully expect AFTER APPROVAL. Thanks for sharing that, it was very cool. I can't wait until we have approval under our belts and we get to see that type of marketing for the DViS.
Just the types of images:
The links took you to a web page where still 3D images could be viewed, just like the stills (and in some instances rotating) images that Dean has made publicy available. I didn't see a single live demonstration by Medtronic or GE of their equipment working live and generating live images from their pre-approved devices. What I saw were still images that may or may not have been generated by their pre-approved devices. We have seen posted on this board links to the exact same types of still images from the DViS. The point was, of course, that several posters were asking Dean to show a live demonstration of the DViS. I was curious if other device manufacturers did this; i.e. commonly showed live demonstrations of their equipment before it was approved. As far as I can tell, nobody has provided a link to such a demonstration by any device manufacturer. Instead, what was linked were stills of images just like the stills of images that Dean has made publicly available.
Certainly the technology does not even purport to be as advanced as the DViS, it was just that what the other device manufacturers do is exactly what Dean has done... provide examples of images, but not live demonstrations. So once again, Dean has acted consistently with other manufacturers.