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If you don’t have at least 200,000 shares of Imaging3, you will be kicking yourself by the end of the year.
I think a major law firm that deals with FDA submissions knows a little more than you. I have been telling everyone all along that a new 510K would be submitted. It will be submitted with all improvements that have taken place in the past three years. Great News!!!!!!!!!
Sorry, No PMA!! New 510K with all improvements in next two to three weeks.
Sorry, Dean will for sure not go the PMA route; and NSE does not end the 510K process forever. It will go beyond the 30 day requirement and a new 510K will be submitted which will include all the DViS upgrades that have taken place in the past three years.
It is my belief that, since Imaging3 received NSE, we will be seeing a new 510(k) filing. This would be the quickest way for approval. An appeal does not seem to be even remotely considered and the De Novo process while it looks good on paper has the probable outcome of turning into a 18 month clinical trial which is obviously not something any of us want. During one of the conference calls, I asked Dean if there had been any improvements to the DViS since submission. He said there had been a number of improvements but if approved it would be as submitted; any improvements would require a new fillings. Since Imaging3 received NSE, these improvements would be allowed when filing a new 510(k).
During one of the conference calls, I asked Dean if any improvements had been made to the DViS since first submission. His response was that a number of improvements had been made and the response time was much faster. He also said that if approval was given, it would be for the machine as it was at the time of submission and any improvements would need further approval. My question is; since application was turned down, can he include any of these improvements when he reapplies? I would think he would do this, but it seems to me it would then become even more difficult to compare it to an existing device.
I don’t know where you get 181 days but from Feb 1 to July 1 is 150 days.
That is a possibility
Maybe he will, maybe he won't. He may have received approval yesterday and is waiting to after today's close to make announcement.
I’m aware of that. That is why I say he will not make announcement right away.
Even if FDA approval came today, Dean will probably not announce it until tomorrow at the earliest.
I guess what your are saying be FRUGAL. If approval doesn’t come by Sept. 09, sell, sell, sell, so I can buy at .07.
I have a strong feeling approval will come on Sept. 7th but, I would be stupid to sell if it doesn’t. Anyone who sells on Sept. 09 because IMGG has not received approved by then deserves to lose when approval happens shortly thereafter. Please don’t listen to Bigbreak. He is hoping approval doesn’t come by Sept. 09. He is hoping people panic so the PPS drops to .05 so he can cash in on your stupidity.
You need to pay them upwards of $6500 to receive one of their reports, but no one pays them to create a report.
Marysawa92 also made a true statement about upgrades. I asked Dean on the conference call about upgrades. He said that since they can’t be included in the DViS until further FDA approval, they will be free. He didn’t go into detail but I would assume there will be a time limit on these free upgrades. He also said that once you receive FDA approval, all upgrades are approved relatively quick.
If you are looking to purchase a large block of IMGG, you better place a bid of at least .29. JMO. After today you will be lucky to see .30.
The current bid price is .27 If you want shares and unless you are order is for 100,000 shares, what is half a cent?
The volume has ground to a halt because no one wants to sell. As I said before, anyone selling now probably needs the cash; otherwise they are just nuts. Selling now is like someone who is give the choice between a new Mercedes and a bicycle and they choose the bicycle. But, I guess there are those who would do so.
I load up every time the PPS falls below .25. Unless someone needs the money to buy groceries, they are nuts to sell below this figure.
If you do not have any IMGG stock, why are you on this board?
Good point!
Dean would not have submitted a report that is not favorable; so why would you need to see it? You probably wouldn’t understand all the technical information anyway.
Aren’t you also glad that Dean would not submit radiologists’ reports that would jeopardize FDA approval?
Did you notice the bashers crawled under a rock for a while after Dean’s CC? Now they are slowly crawling back. Next you will hear IMGG is broke even though Dean said he personally could put another $2-million into IMGG. Does anyone actually believe he would submit two radiologists’ reports to the FDA if the machine did not work? People say we don’t know what was in these reports. No we don’t, but do you think Dean would be dumb enough to submit reports that said the machine doesn’t work. I don’t think so.
Dean has done a superior job of keeping stockholders informed; more than any CEO I know of; yet there are those who still complain. He tells it like it is. Just because it is not what certain people want to hear, Dean is being dishonest.
Is there anything positive we can take from your comment? Dean really doesn’t need to tell the stockholders anything. He could be like most CEOs and keep the stockholders in the dark until an FDA application is either approved or declined.
FDA approval on 4th businessday of Sept. which is Sept. 7th; JMO I originally predicted Sept. 6th but I forgot the 6th was Labor Day. Once we receive approvial, I will let you know how I arrived at this date.
Dean said that FDA would have informed him right away if he needed to apply for PMA.
What does this prove. The resolution on whatever you used to capture this still shot is so bad even Deans face is blurred. His face is blurred even before I zoom in. Don't say it is my monitor. I have one of the best video cards, GeForce 8800GT and the resolution on my 21" monitor is set at 1600x1200.
and what might those moves be?
Did you ever think maybe Dean's friends and family are buying at these rediculously low prices?
Remember IMGG will be FDA approved on Sept. 6th. Getting closer everyday. JMO
IMGG will receive FDA approval on Sept. 6th. Hang in there this is less than one month away. JMOP
Medtronic's has 1-Billion outstanding shares. current PPS is $37.53 and at one time it was $60.00. If the DViS ends up being a superior machine, I believe the PPS will end up much higher than we think. I can't believe anyone in their right mind can be waiting for the price to drop before they buy; anything under $1.00 is a bargin.
Can someone go to this page on Medtronic's website and tell me the difference from their imaging device and the DViS? Check out their video of this device.
http://www.medtronic.com/for-healthcare-professionals/products-therapies/neurological/surgical-navigation-and-imaging/o-arm-surgical-imaging-system/index.htm
Imaging3 may be required to sign of on PPM shares, but there is no way for them to know if they sold these shares. If you had restricted share, would you not want to have the restriction removed as soon as the time came available? Besides what is the big deal? You have a good way of interpreting Dean’s statements into being deceitful statements. When he states that he would have no way of knowing what’s going on with these shares, he is making a true statement. But then he may have a crystal ball that tells him each time a stock holder buys or sells their shares.
Does anyone know if FDA classified the DViS as a Class I, Class II or a Class III divice? According to what I read Class III are the most difficult to get approval.
Sorry about the poor English. I meant to say trying not try.
Mr. Sano; I am try to determine why you bother to post on this discussion board. Are you a humanitarian who is trying to save everyone from financial disaster? I think not.
I would be curious as to when Dean’s last phone discussion took place with FDA and what was discussed.