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Imaging3, Inc. is pleased to announce that on Tuesday, January 12, 2010 at 1:00pm PST, (4:00pm EST) the company’s CEO, Mr. Dean Janes, will be hosting a conference call. To join the conference call, please call 1-877-757-0918 and enter passcode 681029 followed by the pound sign (#). You will be connected to the conference call in a listen only mode, and then lines will be opened for questions following the presentation.
MY E-mail from the company says that they are happy to announce!
Imaging3, Inc. is pleased to announce that on Tuesday, January 12, 2010 at 1:00pm PST, (4:00pm EST) the company’s CEO, Mr. Dean Janes, will be hosting a conference call. To join the conference call, please call 1-877-757-0918 and enter passcode 681029 followed by the pound sign (#). You will be connected to the conference call in a listen only mode, and then lines will be opened for questions following the presentation.
The purpose of the call is to update Shareholders and other interested parties of the current developments with the company’s 510k FDA submission. Currently the FDA has requested further information and Mr. Janes would like to discuss the company’s plans to address these questions.
A recording of the conference call will be made available on the company’s website as soon as it is available. Imaging3 will notify shareholders and others who are on the company’s e-mail opt-in list. Anyone who would like to be added to this list is encouraged to sign-up for the e-mail based newsletter on the company’s website using the following link - http://www.imaging3.com/newsletters_signup.html.
Imaging3, Inc. is pleased to announce that on Tuesday, January 12, 2010 at 1:00pm PST, (4:00pm EST) the company’s CEO, Mr. Dean Janes, will be hosting a conference call. To join the conference call, please call 1-877-757-0918 and enter passcode 681029 followed by the pound sign (#). You will be connected to the conference call in a listen only mode, and then lines will be opened for questions following the presentation. {Dean must be pleased to answer a couple more questions, and that's it before approval!}
Mike recieved the confirmation on the 17th, meaning the fda recieved the info asked for on the 11th, is my understanding
you got that kind of back wards don't you? did't Dean use to work for Toshiba; look what he did, after He got away from them!
Radiation is so far below the competitors; I don't buy in with your{ bet they will use the full sixty days plus some idea}. I do believe in the product.{priod} The FDA is a government run, and what seem like a delay to you and I is just the way they operate. Opinion.
one of those exact dates
or the desire
I don't have the time, but there are a lot of past posts that explain, if you really want to know, you will do the DD
No doubt that Dominion can make peoples lives better and in fact save lives. FDA must approve because lives hang in the ballance. Especially medically, and also many vast other uses not even thought of yet. Security being another major item. If we could make a big enough one, put the earth in it; we could show the global waming yahoos that the earth is filled with molten lava{HELLO!} the skin temp of the planet may go up and down {HELLO! McFLY...ANY ONE HOME?} . mmmmmmm lol happy new year
congratulations
Want to know about INTENDED USE STATEMENTS? From YAHOO: Info for your DD pleasure!
The intended use or indications for use of a product are the claims that the company wants to make about the product after approval. http://myraqa.com/intended_use_statement...
By FDA regulation, 21 C.F.R. § 801.4, the intended use of a device refers “to the objective intent of the persons legally responsible for the labeling of device.” Thus, the intended use is controlled by the company’s own words.
The definition does go on to say that the intended use can be established by known off-label use of the device. That portion of the regulation, which has created considerable confusion, can essentially be ignored.
The intended use is determined by the applicant, not by subsequent third party use. If FDA believes that a device that is the subject of a 510(k) premarket notification is likely to be used off-label and that a particular use may present health risks, FDA can mandate a warning against that use. FDA cannot, however, reject a 510(k) because of anticipated off-label use.
The intended use will delineate and circumscribe the company’s ability to promote its IVD. All “labeling” must be consistent with the intended use.
Labeling is broadly defined by law, and covers virtually all promotional materials created or distributed by the company or its agents. Oral communications, such as statements by sales representatives, must also be consistent with the intended use statement. Claims that go beyond the labeled intended use are deemed off-label and can result in FDA enforcement action.
Thus, submitting an application for a narrow, unmarketable intended use simply to obtain FDA clearance can result in a commercial dead end. The product may lawfully be sold, but the ability to promote it would be fatally constrained.
Intended use should not be drafted solely with the input of regulatory personnel. Sales and marketing personnel should provide guidance, as well. Companies must consider the potential impact of the intended use on the commercial success of the product.
The FDA regulatory process will culminate in an approval or clearance for a clearly defined intended use. The final labeling will explicitly state the product’s intended use.
http://www.genengnews.com/articles/chite...
For a fantastic flow chart on Intended Use Statements by the FDA see... http://www.fda.gov/MedicalDevices/Device...
4. Indications for Use Statement
We recommend that you use this section to provide the indications for use statement, which is a document where you identify and describe the specific indications for use statement for the device(s) included in the 510(k) submission. Your indications for use statement should be exactly the same as the indications for use listed throughout the rest of your 510(k) submission, including the indications for use in the device labeling. We believe that in order for FDA to adequately review your submission you should identify whether the device is intended for prescription use and/or over-the-counter use.http://www.fda510k.com/510k-sections-and...
Come to your own conclusions....
me...Long & Strong... Rating :
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if all of his approvals came early before; never had to wait this long
sorry earl, thought I was responding to bigstud; my bad!
why don't you find out and come back and tell us? be cool for once in your life
theythe are so good , he used them twice
From Yahoo: DECISION DATE HAS NEVER CHANGED! (60) DAYS) People please read the following which I have copied and pasted from the FDA site. The decision date was really never going to be any earlier than 60 days from the last AI (addition information) submission sent by Dean. I think Dean was hopeful for the 30 day decision given his relationship with the FDA but I truly believe he should have kept the information to himself and told everyone to take a look at the FDA guidelines. It clearly states 60 days from the second or later AI request and submission. This would put us around Jan 12th if the FDA received the submission by November 12th. Of course this is an estimate plus or minus a couple of days. AGAIN!!! ANY DAY NOW! STAY STRONG AND HOLD ON TO YOUR SHARES!
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Public Law 107-250, amends the Federal Food, Drug, and Cosmetic Act (the act) to provide the Food and Drug Administration (FDA) new responsibilities and resources. A provision of MDUFMA authorizes FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2002, including premarket notification submissions (510(k)s). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet the performance goals identified in the letter from the Secretary of Health and Human Services to Congress (Goals Letter)1 and summarized below.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required.
1This letter can be found on the Internet.
II. Purpose
The purpose of this document is to assist agency staff and the device industry in understanding how various FDA and industry actions that may be taken on 510(k)s should affect the review clock for purposes of meeting the MDUFMA performance goals.
III. 510(k) Performance Goals
For 510(k) submissions, the performance goals contain both cycle (i.e., "first action" and "second and later action") goals and decision goals. A "cycle" (or review cycle) is the period of time (in FDA days2) beginning with the date FDA receives the 510(k)3 and ending with the date FDA issues a letter requesting additional information or announcing a "decision" (e.g., substantially equivalent (SE) or not substantially equivalent (NSE) determination). More than one cycle may occur before FDA issues its decision on the 510(k) submission.
The table below summarizes the 510(k) performance goals under MDUFMA. FDA has committed to meeting the following action and decision goals for a specified percentage of submissions, depending on the fiscal year:
an FDA decision (i.e., issuance of a SE or NSE determination letter) will issue within 90 days (cumulative FDA review time)
first action additional information (AI) letters will issue within 75 days
subsequent action additional information letters will issue within 60 days.
Table 1. 510(k) Performance Goals
Action Review Time
(FDA days) Performance Level (by FY)
(--- indicates no quantitative goal)
2003 2004 2005 2006 2007
FDA decision 90 --- --- 75% 75% 80%A
First AI letter 75 --- --- 70% 80% 90%
Second or later AI letter 60 --- --- 70% 80% 90%
2The term "FDA days" refers to the amount of time a submission is under review by FDA and does not include the time when the clock has been stopped.
3The recorded receipt date of a 510(k) submission is the date the submission is received by FDA or the date US Bank notifies FDA that payment of all fees due has been received, whichever is later. For additional information, see "Premarket Notification [510(k)] Review Fees". Rating :
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Why be-Long IMGG Re: For a Happy New Year: 2 minutes ago Look at vermillion, went to $14 in one day then continued up to $20 and was in BK at the time. This product will replace or compliment the use of all the MRI, Fluoroscopic, and CT scanners in use today. My daughter is a radiologist for spectrum health in michigan and I've discusssed this with her. Just the Simple fact that you can take the devise to the patient, will revolutionize emergency medicine; plus the use during a whole operation{extended use} is a major factor, especially real time. With durrent equipment, you take a still, from a sheilded position, then wait a minute or so for the image to appear. Look at MRI,; many people are claustrophobic, especially children. One can only imagine the limitless possibilities. Then there is homeland security, air port screening etc.etc....Dean said we can make these thing as big as needed. Could drive a truck through one! We must get FDA first, then the rest will fall in place.
For a Happy New Year: Stay with IMGG, it's not a matter of if, but when FDA will apporove the Dominion, and I believe $4-$5 run the first day $5-$12 the next. You will be glad you did.
going on vacation is the ultimate sign of confidence
Merry Christmas , Ahead of time;Rock this stock today, and through the NEWs year!
you might be a red neck if you are so insecure with your man hood that ya have to call yourself {big stud} in capital letters, do you also drive a corvette?
After- noon Rally time News is on the horizon, and some money was made this morning; now time to get back in for the overnight express
you are the only one that seems to be upset today
I think your initial reaction should have been buy back at .635 and ride the spike like a tow rope to the top of the hill; then decide what to do {next week }when it gets here. You have too many ifs.
looks like 4 million share trades in about 20 min?
so I could pick up another 1K share
mojo - rising
just re-coiling back to catapult past $1
probably due in today's mail; California time!
another surge baby!
Army of buyers are BACKAKAKAKAKAK!!! keep it up!!
this is ground control to major tom, take your protein pill and put your helmet on!
no, I just try to pick up on O.P's point of view. I've seen analysis being done. This security may follow charts to a degree, but I believe news is a way bigger factor.
Looky Likey Friday Rally
watching closely, lost some position but regained more on the dip , I am definately looking for approval soon
Strengthened my position , lets go
Haven't seen too much of that today
that's the same one he uses on yahoo first initial b, lebovitz
YOU can bet your hind end the FDA knows exactly how much radiation is emmitted during every type of testing the Dominion does. I'm wouldn't doubt that the NRC would have to have a file on it because it is a source of radiation also. I'm sure all that info is at their finger tips.