actually conducting DD
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Have the pictures that the FDA wants and needs been acquired??
Have the pictures been acquired??
How can there be such volume when there is no news??
Have the pictures been acquired yet?
Have the required pictures been acquired??
Any news??
on the aquisition of the requested/required images??
Why did MTV have to re initiate coverage
For this stock??
Nobody will bully Janes into hurrying the re submission. Says Janes.
Is that because he knows that once he re submits it may be curtains?
Question after watching the MTV episode
is there an agreement with the FDA after the October meeting?
did they start to aquire images?
what is pending approval?
Does anyone have any news
on how far along Imaging3 is on acquiring the required pictures?
He actually has to convince the FDA
Of course, if he could convince some heavy hitters, get them on board, make the best run at the FDA...that would be even better.
Any news on obtaining the pictures?
After the October meeting with the FDA
Dean Janes never indicated that what was allegedly agreed upon was not achievable by the company.
Ponder that.
Two years plus
Since the first NSE warning from the FDA
And counting
FOIA requests take a while;
especially during the holidays.
Mine is still outstanding, and the information technician assigned to it, Claire B. Stansbury, is out till next year.
If there is a resubmission by the end of Q1, 2012, it will be almost a year and a half since the NSE letter.
I suspect however that there will be "problems" with the capturing of images and that will be the reason for a necessary delay in order to make sure that the resubmission is "spot on".
This is not the time to hurry, will be the new battle cry.
Why have none of the big boys come up with 3D real time yet??
Imaging3 is certainly giving them plenty of time to enter the market and steal their thunder.
And if the patent was a problem, Dean would be reporting the many attempts by the big boys to buy it, partner with the company, etc, etc, etc.
Btw, my appeal has been docketed and a briefing schedule established.
I could agree with you
if the 99% were composed of non insiders, non family and friends.
but that is simply not the fact
Homer,
if approval was coming, there would not have been today's sell off;
resubmission will indeed be forthcoming; approval will not.
Here is my prediction and why
Early Q1 if approval is goal
Late Q2 or later, if other goal.
whoever took the pictures
made sure to get the infringer (Janes) using his booth (and meeting with the people from the carcass company)
Lobcrab, "other goals" means
as others have suggested, this may just possible, likely, hopefully not, but the signs sure seem to indicate, that this a SCAM and, you can figure out the master plan from there...
Lobcrab, they met with the FDA over two months ago.
If the ultimate goal is re submission to get approval they would be done with images by now.
If re submission has other goals, then it explains why nothing will start till next year.
Agreed lobcrab.
however, there is simply no way they are going to get the required images in 30 days, followed by the required report and resubmission by the end of Q1.
It may be called a 510k
but its turned into the practical equivalent of a PMA
from a legal standpoint, a re submission is a must
from a practical standpoint, a re submission will not happen till Q2 or Q3 at the earliest
If what is required by the FDA is indeed correct,
10 patients, etc,
the time frame of 30 days is not realistic.
???the source of this update is??
Dr. Polk??
Good volume today!!
If you need a year end tax loss, what better way to generate it.
I have a copy of the pictures from the complaint.
Pretty close if not legally identical.
Excellent new plan!!
No more deadlines.
If the consultants dont think the application is ready, its not Dean's fault.
The FDA has no reason not to give approval to a device that will be used on dead cows!!
Why stop there?? Sky is the limit; how about dead anything.
Load up and hang in there, approval is almost a guarantee now.
I was also curious
about the stock issue; showing green at this trading level??
Does anyone know??
Has the company started the process of acquiring the requested images per the alleged agreed protocol?
There can be no resubmission whithout those.
I suppose because of the holidays, Thanksgiving, RSNA and Xmas, the important work will not start till 2012.
Best line at the booth contest.
My entry. HANG IN THERE, FDA APPROVAL IS COMING!!
This is the 8th RSNA WITHOUT FDA approval.
What does one say to the booth people from past years??
Do you know any good consultants??
The big difference is
I was kidding; are you serious??
I disagree.
Best volume in a long time.
Whatever visitors are seeing at the booth is translating into lots of buys.
Agreed.
There has to b a buyer for every seller.
The question has to be are there more sales initiated than buys requested.
Otherwise, the market would stand still everyday because of your obvious statement.
Selloffs would never happen etc etc.
No, not correct.
I was answering the post which claimed that the meeting was conducted under a rule which mandates a written agreement between IMGG and the FDA. That was in response to my opinion that there is no agreement in writing between the FDA and IMGG flowing from the October 17th, 2011 meeting, otherwise, I am sure that Janes would have disclosed it as a material event.
What I am suggesting is that more likely than not, the meeting was a rehash of the NSE letter and no agreement was reached. The FDA simply made it clear that among other things, IMGG had to produce, in acceptable form, images from live patients and comply with the rest of the NSE items.
If a definite agreement had been reached in writing, enforceable against the FDA, I cannot imagine Janes not saying so.
What was the buy to sell ratio today?
If I read the 2001 regulation correctley, and the meeting was held under its provisions, a memorandum agreement is already in place between IMGG and the FDA.
Sorry Homer,
I exclude from "in writing" the numerous letters from the last failed application as well as the plain english NSE letter.
I guarantee you that the FDA did not put in writing what they agreed to or talked about at the October 17th, 2011 meeting.
I also guarantee you that the FDA did not committ itself to anything.
I finally guarantee you that none of the negative/critical things in fact told by the FDA to Janes and his consultants at that meating, would ever be revealed, as it would go against his nature and repeated MO.
And rest assured, there were plenty of non flatering comments, which made the one hour meeting "seem to last foreever".
Homer, I agree.
Janes simply cannot afford not to resubmit.
And it will probably happen in Q1.
However...
The FDA will find deficiencies which will be due to a grave misunderstanding of the agreements which IMGG thought they had reached at the October 2011 meeting.
Never again will they simply trust the word of the FDA; next time it will all be in writing.
So, the request will be made to the FDA to agree to the protocol, etc, in writing, which the FDA will refuse to do, leaving IMGG no option but to blame the FDA and be at the mercy of their whim and if this medical breakthrough, now half a decade in coming, does not get approved, what can one of the most tenacious people in the world do but try and try and try and try again.
Can we just call this year to an end early and just say it now; 425 days since NSE and counting...
393 days since NSE, and counting.