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Lamb, I have no problem with distrust of Dean, it can be done with tact as you have shown! But, look at the resubmit this way...for Dean, it's like taking a failed test over again! Dean knows the questions, the consultants know how to format the answers.....a very clear path if you ask me!
Nascar, UFC...now there's some exposure for Dean and IMGG!! Excellent idea Lamb!
Maybe he's testing flow while waiting on electronics? Maybe he's testing cut-in temps while waiting on cut-out limiter? There is always something to test while waiting on other parts!
I don't see a thing wrong with the sponsor endorsement, It gets IMGG exposure and visibility! Some will never be happy with what Dean does, and if all the red flags were true, I'd be long gone instead of watching the daily pps and public events!
Homer, it wasn't mentioned, just noise! ......I spoke with the head of the Dept., he said things were lookin good for IMGG LOL
.0339-.034 is what I have showing!
adrian, I was doing DD long before IMGG was brought to your attention! Radial artifacts from DVIS cone-beam can and are eliminated by changing the algorithms, that is widely known, I'm surprised you weren't aware? PS.. I meant to say...no one except Dean!
How do we know that was his opinion, or even his article, or even about the DVIS? You have actually spoke with this man in Japan? What was the date? No one has patented and developed real-time 3D, so Dean is in uncharted territory here, many will doubt it works, because they haven't thought of it!
"Discovery Phase"???? WTF? I wonder who would come up on Nessen's email records from the past?
A year or two from now.....someone will have already bought my IMGG shares long before that!
Dr mugs, again, with all due respect...your saying the FDA knows the DVIS doesn't work, yet they are going to meet with Dean to discuss another 510k? Seems to me, if you are correct, they would have turned this request down, but, they didn't! Unless of course, we have new data for them!!
Dr mugs, with all due respect, The FDA and Bogdan's lawsuit have nothing in common, jail is NOT, and WILL NOT be an issue! And, what are your odds Dean has made the meeting up?? Please, the past does not count, we are in the present now!
adrian wrote...... No Judge will ever accept the ignorance of this fact as an excuse. JANES IS GOING TO JAIL.... adrian, Dean is meeting with the FDA! Is there some confusion about what is happening regarding this meeting? I'm pretty sure there will be NO JUDGE at the meeting?
smf, are you saying millions of dollars worth of IMGG stock would be bought? Do you think the pps would stay up? That is what happened on the previous run. The only thing that will take this up and keep it up is approval.
Don't know if this is correct? It is from an SMF post............A request for an Agreement Meeting will be logged in as a pre-IDE for tracking purposes (flagged as an agreement meeting request) and assigned a number (e.g., I000001). Within 7 days of receipt, the team leader for the submission should contact the applicant to establish dates for pre-meeting(s) and the formal Agreement Meeting. As specified in §520(g)(7)(A), the formal Agreement Meeting should occur within 30 days of receipt of the request. It is strongly recommended, however, that a mutually agreed-upon timeline be established to increase the probability of a successful meeting. Therefore, the applicant may request deferral of the formal meeting until one or more informal pre-meetings is completed....
Well, if WDRP is a reporting "pink" they have 4 days to file an 8k. The "CHILL" was not a result of WDRP actions,as in a halt, it was the DTCC action on National. I just don't see the tradeable opportunity here?
Gold, I don't believe a new TA is a tradeable, material event, whether disclosed to some or not! As long as a public release was made in either case, I see no problem, actually, I and others couldn't trade until this was resolved!
Well, It is obvious, no one can back up the claim of "it can't work" with any technical data! Between the Patent, and Dean's OH Demo, I rest assured that the DVIS does in fact work in realtime!
Adrian, can you please give us some technical reasoning behind this statement? The DVIS seems to counter your theory?
Very good question 4 real, I just can't imagine that scenario either? Free time for IMGG?
I spoke with 2 FDA consultants, and they said they had no comment, as it would be quite complex, but would be glad to assist if I were interested in bringing them onboard to submit the DVIS.
Man, that's good news! Thank you Wyo, 1 down, 1 to go!
I believe you may be able to complete a WDRP trade, but the trade will not settle and fail?
Scottrade uses DTCC, that is why WDRP is froze.
Wrinkles, on Scottrade homepage positions, there will be a parenthesis around frozen ticker!
That's correct! There was no advice other than....wait till it's lifted! I'm not sure if it's TA related or not, whether DTCC lifts the CHILL?
This isn't a CHILL, it's a FREEZE, Bunch a BS! Scottrade WDRP frozen!
Dr mugs, you clearly requested a FDA link. As far as the letters to IMGG are concerned, the FDA does state that another 510k application can be made. I would recommend more research on the "least burdensome provision on the FDA site, and yes, it applies to both PMA and 510k's, nice try tho!
mugs, I am, as always, glad to help! Specifically, section 513(i)(1)(D) states, “Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations. In making such a request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly.” Section 513(a)(3)(D)(ii) states that, “Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness. The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.”
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mugs, doesn't have to be LIVE, The least burdensome approach will work, and, yes, it looks like it will be accepted! Dean has covered all the data asked for!
Lambster, they are asking for clinical information, data,..comparisons, not test results. Aside from a different intended use, the images should be comparable to the use of the predicate. I'm not even sure what TEST would be used? Images are the key.
This is from the last paragraph of the same letter...." The information requested above represents the issues that we believe need to be resolved before our review of a NEW 510K submission can be successfully completed".
They (FDA) will accept a new 510k!
Dr mugs wrote....."Janes can not give the FDA these results because his device is a total sham!! The FDA believes that the real time "3D fluoroscopy" and 3D diagnostic imaging indications constitute a new intended use." I believe these two sentences are contradicting for the DVIS...how can it be a sham, and a new intended use?
WOW Homer!, does this mean we are not going to .03 as some predicted? Dean has actually finished phase 1? Amazing JOB!
Well, I stand corrected, so a class 111 can be applied as a 510k?
This is what the posted meeting criteria is about..."FDA’s Evaluation of the Application of the Least Burdensome Principles
in Early Collaboration Meetings " It's not pre-510k.
Thanks adrian for reminding us of the difficult path Dean has traversed to get to this point, closer and closer to approval!
Your right, seems proper forms were not filed regarding executive change or felony report!
Page 4, paragraph 13 and 14, tells the story!