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King Kong Guru
A lot of people on this board are trying to determine how many days have passed since IMGG's last AI submittal. My question is; when you say 230 days for the longest submittal thus far, are you counting from that company's last AI to their approval date or from when their 510K was actually submitted to approval? TIA for your response!
DAK424
Jacquie
I keep in close contact with the company and there has been no other requests from the FDA since the one you mentioned back in early July. If you read King Kong Guru's post #29943,you will see where I, and others, believe we are in the process. I believe the 510K application has already been completed by the review team and is awaiting final review by the Branch Manager. We should be very close to the end of this whole ordeal. Hang in there!
Dean Janes doesn't have to "prove" anything to you or any other investor for that fact. His burden of proof is only to the FDA and any potential buyers of his device or company. If you don't believe it works as advertised, that is your problem. I, for one,do believe it works and the market will either support that belief or not support it once approval comes.
Thanks Admiral!
Dean submitted his 510K application for the DViS in June of 2007. I don't recall the dates of the AI requests between then and December of 2009 when the old review team was replaced with the current one. However, Dean was told late last year by one of the Directors (who was replaced along with the old reviewer and her boss)that he would approve his device if he would clarify the "intended use" statement in the DViS manual. Dean complied and was awaiting a response when the old team was ushered out and the new one ushered in.
In January (I believe) of this year, he was contacted by the new review team and presented with a list of 18 questions that they had compiled (AI). He was also asked to include a third party radiologist's review to make it easier for them to approve the DViS. Dean was at first hesitant, not wanting to go down the PMA route. After being told that was not their intent, Dean set out to respond to their requests.
Most of the questions were answered very quickly, but the radiologist's review took some time and, upon completion, was sent to the FDA on April 5th of this year. The FDA acknowledged receiving the package on 4/9, but, apparently, didn't stamp it received until 4/14 (?).
Dean was then contacted in early July by the FDA because they were having issues opening some of the complex image files he had sent, along with not knowing where to insert the third party radiologist's review. The FDA was also contacting him regularly about questions the old review team were asking. That is when Dean decided (on his own, not an FDA request) to send them a whole new package explaining how to open the files, where the radiologist's review should be inserted, and annotating any issues brought up by the old review team (anticipating future questions based on what the new team was asking). This was not considered AI and the clock was not stopped.
Sorry this took so long. I hope it helps.
Better get your certificates ready for trading.
See post #26391.
Thank you very much!
Shaka
With all due respect, if we were going to go the PMA route it would have already happened. Not to mention that the FDA made it clear to Dean that they had no intention of going down that road whatsoever.
With the recent posts from IS guru and mugs, it seems clear that we could still fall within the 150 days from the FDA's standpoint. It took them over a week to make Viking's SE public and yet they still showed the response as within the 150 day time frame.
Everyone has gotten very emotional about this whole process because it has taken so long. I, myself have owned stocks for 5 years and never would have believed it would take this long to get approval. At this point, in light of all the recent information, it makes good sense that we should get approval very soon. Probably next week if I were to place odds on it.
I stay very close to what is going on through my ongoing conversations with Mike Nessen and would have pulled out long ago if something didn't seem right. I actually believe we have already been approved and the paperwork is going through its final stages before being released. Keep in mind, that is my opinion only, based on all the information that I have digested.
In closing, all (3) of the NSE's from the hundreds of 510K's processed from May through July of this year (IS guru's collected data from the FDA) were notified before 60 days. All logic leads to the conclusion that we are getting approval and it will be very soon.
The only reason people are attacking you is because they/we are extremely frustrated and they are lashing out at anyone that doesn't agree with them. Don't allow them to take away your peace of mind. Sorry to bend your ear and hang in there.
Yes. According to the company they can do both.
ysung
Please, call Mike Nessen on Monday and he will explain to you why this audit was triggered early. I didn't ask if I could quote him on the details and didn't want to cause any possible problems for him. Thanks!
Someone earlier in the week posted they had heard that the FDA toured IMGG. I, as did Dr. Polk, called Mike Nessen and he confirmed. Call him and he will give you the details.
Thanks IS!
IS-guru
I understand that out of all the 510K applications from May through July, only 3 were found to be NSE. And, those 3 applicants were notified that they were NSE within the first week, or so, of submitting their application. Is that correct?
Excellent job IS! Thank you for all your hard work.
I spoke with the company this morning and this had nothing to do with their 510K application approval. It only had to do with an early audit.
According to IMGG OR BUST (a federal regulatory attorney, the FDA starts counting from the day after they receive the application. If that means the next working day, then that would be a Monday because they acknowledged receiving it on 4/9 which was a Friday and that would make the next working day, 4/12, a Monday. Ifyou start counting from 4/12, then this Thursday, 9/9 would be exactly 150 days.
Bust
Does the FDA base the 150 day period on calendar days? If so, then this Friday (8/3) would be exactly 147 days (or 21 weeks) from the 4/9 date that the FDA acknowledged receiving the 510-K, which would make Monday, 8/6 (a holiday), exactly 150 days.
Assuming the FDA is trying to meet that 150 day period, would that mean they would try to issue approval by this Friday? I realize this is an arbitrary time period, but was curious as I respect your opinions. TIA.
Excellent post!
Please refer to post #23387 by BennyJ. Apparently, the FDA has hit 150 days on ALL of their 510K applications for the past two quarters. It seems reasonable that they will continue this trend in light of the pressure they are receiving from the public as well as Congress.
Yes, and I believe Phillips is the other.
If the DViS can't do what Dean has publicly stated it can, then he has committed fraud and would likely go to prison. There is much more reason to believe the device does precisely what Dean says it does than to believe any unsubstantiated claims that it doesn't.
That was an excellent synopsis of the conference call. Great job!
That was 6 months ago when he thought he was going to get approval and, instead, got a new review team to deal with! In all of the recent Money TV interviews, Dean has looked fresh, enthusiastic, and very upbeat about how the whole process is going now. He has a wonderful rapport with the new review team and knows we are drawing near to an approval very soon.
That isn't what happened. The FDA never came back and said they weren't happy with the wording. They cleaned house and gave us a whole new review team before the old team could render a final decision.
Beautiful reply!
Good post bcatch, I totally agree!
I might also add that Dr. Polk has been the CEO of two, and I think possibly three, medical companies throughout his career.
I apologize if I gave the impression that the reviewer,et al, were terminated because of bribery. I should never have said "as a direct result". They happened to be part of a group that was terminated as a result of the new head of the FDA coming in and cleaning house.
Does everyone here understand what happened last year with the old review team? The old reviewer and her boss were responsible for dragging this whole process out over several years by nitpicking over every minute detail. They spent four months alone hammering Imaging 3 on mammography issues even though Dean had assured them that they already deleted that from their brochures and had no intentions of getting the DVIS approved for mammographies at this time! Every question had to be answered in writing and every answer reset the clock. That is the reason this has taken so long.
After a conversation with one of the FDA's Directors last year, Dean was assured that if he clarified his "intended use statement" his device would undoubtedly be approved. Please tell me, how could anyone have known that shortly thereafter that specific Director, the reviewer, and her boss were all to be among those that would be terminated? The terminations, by the way, were a direct result of bribes and payoffs that had been uncovered by the new head of the FDA which leads me to believe there is nothing nefarious going on behind the scenes at this time. In light of the terminations, the new personnel will no doubt tow the line for at least the time being. The 3rd party radiologist review was requested by the NEW team in order to make it easier for them to make a decision and approve the DVIS since they were coming in after the fact.
IMGGorBUST mentioned that he believes the new review team is treating this as a new submission and I tend to agree with him. This means Imaging 3 is most likely not on a "fast track" and the 90 days (for what it's worth) would end (as Dr. Polk suspects) on, or around 7/23. That would be 90 days from the last written request on 4/23. I hope this helps.
"The firm may supply the requested information by telephone and would not have to submit this information in writing. Obtaining such clarification via telephone does not affect the official
review clock."
This appears to indicate that the clock would not be reset irregardless of whether or not IMGG was on a "fast track". At one point it wasn't clear if they were still on a fast track or not, but either way the "60 day" timeframe should have started on either 4/9 or 4/12. Not that the 60 days means a damn thing to the FDA!
There is not, and never has been, an IMGG device at Toshiba. The only devices currently out in the field (1 complete working device and 2 in lesser stages of working order) are being used by IMGG personnel only. If you don't believe that, then please do your own DD and contact the company to hear it straight from them.
As far as not falling in love with a stock, I suggest you tell Warren Buffet that.
Columbo? I just have one more question.........
Do they allow mountain bikes (bicycles)?
With all due respect, the information you received is incorrect. The minimum investment was $5K per individual and I can personally account for about 7 million shares between many close friends and family. I also know of another investor that bought over 5 million shares himself. I was in very close communication with the company at the time and I guarantee the 107 million shares was comprised of many individuals. Please contact the company if you would like further verification.
Dr. Polk is a major investor in IMGG and speaks with Mike Nessen frequently.
When I went on OTCBB to look at IMGG's stock price, I clicked on the "Micro Stock profit" stock alert and was curious as to why Siemens and GE's charts were listed along with IMGG's. Anyone have any thoughts? Just curious.
Again, the shareholders meeting never took place so there was never a vote. Imaging 3 and those close to Dean now own a majority of the shares so the threat of a takeover is no longer an issue.
The shareholders are the ones that would have decided to authorize the additional 250 million shares during a shareholders meeting, not Imaging 3. Mike Nessen said the shareholders meeting didn't take place because the SEC told them the paperwork was filled out incorrectly even though they filled it out while the SEC rep was on the phone with them.
The 500 million (actually, I believe it was 250 million) shares were not going to be "issued" by Imaging 3 they were going to be "authorized" in order to prevent a hostile takeover. In other words, if GE were to come in and buy up a majority of the shares by offering $1.50 per share and enough shareholders sold them, they would end up becoming the major shareholder of the company without ever having to negotiate at a potentially much higher price down the road. If that happened, Imaging 3 would then issue the additional shares that were authorized and retain a major stock position in the company, thus averting a hostile takeover.
The SEC did not stop Imaging 3 from authorizing the shares, they told them their SEC paperwork had not been filled out correctly and needed to postpone the shareholders meeting (so all of us could vote on authorizing the shares) until it was filled out correctly. Since then, I understand that Dean and those around him have purchased enough shares to avert a takeover.
This information comes directly from Mike Nessen.