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Shorts on Friday:
20100806|IMGG|597586|1504326|O
40% shorts on Friday. IMO, Shorts/Flippers carry more risk at this PPS.
http://regsho.finra.org/FORFshvol20100806.txt
You started posting only from 07/27/2010. Less than 2 weeks only and still claiming or projects yourself that the whole set of investors are waiting for your word to get into IMGG stock. Laughable...
Never seen any facts based research from you. Feel sorry for YOUR INVESTORS.
It's not matter who goes first in the race. But who wins at last.
Added news: Burbank closest Post office is working on Saturdays. (LOL)
Even though I hate to talk about the Friday approval since we talked about a lot, Here's my 2 cents.
IMO:
Dean should not release the news after 2 hours of the fax received since it gives you only 2 or 3 hours of trading left for the day.
Shorters will be ready/reserve shares to short next monday. (Sykes/moody/interactive brokers/sogo)
It should be a surprise to the investing community/MMs so the gap up will be lot better after the release news.
When the stock was traded at 1.50 company was very confident of getting approval after november 12th submission. if they would have got approval by December 12th to January 12th(Due to inefficiency of the previous of FDA/Corrupted FDA team ), the stock price would have gone more than 3$ and the same debt could have been paid off with further half count of shares what you are taking about here.
He worked for Toshiba earlier. But you cannot keep working for your A** off all your life time and let them take the credit for your innovation. DOMINION is clearly out of the box thinking. Go thru the entire patent info. You will know that. Imaging market is growing pretty fast.
Anything special from Dean's FB? Guys, update please. I don't have FB account yet. sent him a note to accept me. Didn't respond. Seems like he's been pretty busy working with FDA.
I don't know that. I believe this recall for Breakaway imaging's original product(2006 approval). Medtronic bought Breakaway(I think Sano will jump in here since Breakaway was bought out for poor money)
if you carefully look at the recall notice, they stated the month of May this year, but actually got another upgraded version's clearance in June.
But my point is that if they do a recall on one product, it doesn't mean that FDA will have to recall all the other products they cleared based on that product as a predicate.
So Answering to your question, even though if medtronic o-arm imaging system is used as predicate in DVIS application(Dean only knows about this which one he used as predicate for each modalities), it doesn't matter as long as it matches the characteristics(safety & effectiveness of the predicate at the time of predicate's approval/clearance)
Hopefully this clears your concerns.
Here in the below link type device name section as O-ARM IMAGING SYSTEM AND SEARCH. YOU WILL SEE 3 and do your research
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
This is what I am thinking GURU. This is not De-novo review 510k process. We have crossed the stage of De-novo review or not. Also we crossed the stage of PMA or not(Kimble's one of the favourite). PMA is needed or not will be determined earlier stages of 510k process if I understood it correct. (That means intended use)
http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm080252.gif
In the above flow chart we are at number 10
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050996.pdf
Intended Use is going to be similar to like this:
-Replace the O-Arm to Dominion DVIS
-Replace the 3D imaging to 3D real-time Fluoroscopic
-Add 16 slice CT scan(plenty out there in the market already) - Added funcationaliy for DVIS
Intended Use
The O-ArmnTM Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-ArmTm Imaging System is compatible with certain Image Guided Surgery Systems.
Similarities and comparison section will be similar to one described in the document(second link above - 2nd link)
Performance data is going to similar to one what they listed in the 510k in the document.(second link above - 2nd link)
(2 Radiologists review comparing the images in different modalities
2D, 3D and CT. )
we all know safety doesn't matter at all( we are far better than industry standard - 50% less to at the max equal to the industry standard)
if the reviewer OK with radiologist review, we will get approval(effectiveness part of it)
IMGG is going to be approved pretty soon.
Medtronic - recall - what is a recall?
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/default.htm
I don't care whatever it is, if approval is coming soon.
Dean was asked by some poster to differentiate between the closest competition(I don't remember whether he quoted Medtronics or not) but mentioned about the freezing issue. Now for the same reason O-ARM imaging system(medtronic) has been recalled by FDA due to issues. If whoever re-posted that poster earlier can re-post it, that will be great.
Reason for the recall:
---------------------
Reason for Recall The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.
Wow!!! Dean has already mentioned about this issues in one of his earlier post. Now it has been RECALLED and I belive it was approved in June. And it was approved after 10 months if I remember it correct. I need to dig more. No device can match DOMINION DVIS. Go IMGG!!! GO FDA!!! APPROVE IMGG....
First and foremost reason is: Any Form of marketing is against the LAW.
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.
6th, 7th or 8th - one of these 3 days based on my prev experience. But if it has been cleared in July, we would have known by now. As for as know, based on my previous research, FDA doesn't have goals for monthly SE list. it varies from 220 to 290 SE per month. But imaging systems always takes time if they want to see the performance data (more than 90 days). Have seen a PACS system software is waiting for more than 22 months because of the hold up in 2008 & 2009. But things are getting better now. Last month Medtronics upgrade on o-arm imaging system was approved after 10 months. So Hopefully for IMGG soon.
Super, nice find Frank. I downloaded and I will do some research on that and update the board if anything interesting. Thanks.
Premarket Notification (510k)
Introduction
What is Substantial Equivalence
Who is Required to Submit a 510(k)
When a 510(k) is Required
When a 510(k) is not Required
Third Party Review Program
Introduction
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the Act.
Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.
Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
You need to go to the company news letter in IMGG website and find out. I belive original application was given SE for IDE(In August 2008 - If I remember it correct) even though it was filed for commercial clearance. Then again it was filed for SE for commercial clearance. I don't remember it exactly when it was filed again. But remember there was a long gap in 2009 when there was no response from FDA, literally no communication from FDA until September and then in November. Media created big buzz on radiation devices and FDA was approving only big boys applications and very few here and there for small and medium sized companies in 2008 & 2009. It is lot better now after new review FDA team took over in early 2010. Now the process is interactive. Hopefully soon Approval news.
The links you provided all are PACS system(software) if I am correct. No software is realtime. There are number of softwares out there to do once you construct & archive all the images. It's just different way of presenting using the software(2D, 3D and 4D etc) if I understood this correct.
But The real trick is How do you do the real time (within a second, you scan/construct/project) in your viewing system. No system is out there in there in the market. Volumetric X ray imaging is getting popular now. But these all will be obsolute(spelling?!) when Dominion takes over. Bigger players will buy out as soon as Dominion approved.
They pay the cost of invention( a decade of work), patent, future market share(minimum 5 billion $)- all parts of the body and other than medical industry too.
Medtronic: (Total 55 seconds and more)
Sample Timeline in the Operating Room
15 seconds* – For O-arm System 3D image acquisition
30 seconds* – For 3D reconstruction to be displayed on the O-arm System Mobile View Station
55 seconds* – For image data to be automatically transferred to the StealthStation Navigation System, enabling the surgeon to navigate
Imaging3 Dominion - DVIS (Total Less than a second!!!!)
REAL-TIME + High resolution fluroscopy images.
+ cost cheep(half the cost) + Quality(Any other product can't even go closer to Dominion DVIS)
You will see. Patience & Trust needed.
In current the fluoroscopy devices real time is the display rate which is 30 frames a second. The Dominion scans in 360 degrees every .2 to.8 seconds depending upon how many images are acquired in the rotation. These images roughly 30 are instantly entered in to the construct, the first construct may have a slight delay of a second or less as the construct is initially formed, but the proceeding images are updated in real time. The exposure to the patient is minimize by using high dose pulsed fluoroscopy, taking shots at .01 to .05 seconds. These are higher than standard fluoro, but less actual exposure time, so cumulative exposure remains either the same and in certain cases substantially less, up to50%.
Patent info. Great read...
http://www.patentstorm.us/patents/7317819/description.html
complete info with pictures/drawings
http://www.google.com/patents/download/7317819_Apparatus_and_method_for_three_d.pdf?id=aYOpAAAAEBAJ&output=pdf&sig=ACfU3U12-eS5bhTDCpE0ge_hUCRWEsYYKA&source=gbs_overview_r&cad=0
Hubris, why all of a sudden so exitement! Any new news that I am not aware of. The patent info, we know that already. Please share.
The recommendations are not official guidance yet as they will be open to public comment for 60-days, according to CDRH head Dr. Jeffrey Shuren, who spoke to members of the media in a midday briefing.
It will not be in effect minimum for 60 days and max not yet determined based on the public comment -
No change/impact in current pending applications.
http://www.massdevice.com/news/new-device-classification-among-changes-called-510k-program-internal-fda-report
FDA unveils proposed changes to 510(K) program
August 3, 2010 by MassDevice staffThe Centers for Devices and Radiological Health releases recommendations from 510(K) working group; Announces new Class IIb device group; Creation of a Science Council chaired by Dr. William Maisel; Clarification of recission authority among list of possible changes
After 11-months of self-reflection the Centers for Devices and Radiological Health finally showed its hand on the future of the 510(K) premarket notification program, releasing several recommendations for changing the process by which more than 3,000 medical devices are brought to market.
The recommendations are not official guidance yet as they will be open to public comment for 60-days, according to CDRH head Dr. Jeffrey Shuren, who spoke to members of the media in a midday briefing
Painting the tape happened Last week Thursday & Friday also but in the opposite direction. It's the MM way of setting up for the next day open. You can't blame either way. since the volume is low, they control it.
I did research on third party review earlier, Let me dig thru and find out before EOD and let you know.
This 30 days status update process not for interactive review process since the submitter & reviewer are already in contacts thru various channels such as email/fax/telephone/one-on-one/teleconferencing communications. 30 days status update was orignially desinged and used when there was no intereactive review process. That form is still in use for non-interactive process review. In our case that's not needed.
No, the product codes are different. This one is (Mobile X-ray System(IZL), Solid-state X-ray Imager(MQB)). There are other companies also in the market already(Example- recent upgrade by Medtronic o-arm imaging system - June 2010 list)
Proprietary Name: O-ArmTM Imaging System
Classification Names: Mobile X-ray System, Solid-state X-ray Imager
Classification Panel: Radiology
CER Sections: 21 CFR 892.1720, 21 CER 892.1650
Class: 11
Product Codes: IZL, MQB
None of the above which have been already approved in o-arm imaging(volumetric x-ray imaging) is REAL TIME, 3D & HIGH RESOLUTION Fluroscopy images. There is where IMGG stands out from the rest of the competitors. And it included mobile CT too. Half the cost from the rest of the competitors and Mobility is another advantages to move quickly to the ICU, operating theatres and ER.
But IMGG - closest product code - look at 10k filed April 2010. Dean has clearly explained what is the closest product matching and subproduct codes are.
Watch the share price action by MM after 2:30. The last 2 days charts are similar. They hold the price the above the previous day's closing price in the morning and after 2-30 to 3-30 pm they loosening it and closing below the previous day closing price. Is that going to be happened today? Is there any obvious reason for that? Why do they do that? Sell in the morning and cover in the evening, lower the bid the way they wanted to grab cheepies from panic sellers. Don't fall for that.
Big block of buy now, What is the order size?
Another nice read: see page 22 for the timeframe.
http://www.ncsl.org/documents/health/MedDev.pdf
Some more info related to patent.
http://www.warda.me/users/136/20050020902.doc
IMGG 510k is in interactive process. - Reposting
Whoever has already read this post, ignore this and move on.
- FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.
- Since April 5th submission lot of communications between FDA and IMGG. FDA never put a hold on review clock since April 5th. All are informal request/response. No AI formal letter.
- Read the interactive section in the below link to learn more.
- Based on my research, Final decision after the final response varies between 15 days to 45 days(after july 5th response). So approval could come any day in following days.
- All the things are aligning now towards the approval news.
- Buy and Hold or accumulate/average down and be in stock.
- Don't listen to basher or even to me except your own DD/research.
- Whoever is doing bashing now, either they do flipping on their tradeable shares or shorting. But still maintaining their core positions.
- Play safely. Whoever is down 50% and above, after the approval news the stock price will skyrocket.
- People say, there will be sell off due to PPM shares after the approval, no it is not. Lot of PPM share holders know that this company will be sold out for huge premium between 6 to 8 $, they are not selling. The stock price went down due to orchestrated bear raid by some well known sites. They do this constantly to buy cheapies from panic sellers.
- FDA is in final stage of the review process(performance data review/radiologist review comparison)
- Mark this post. Approval is before September 5th(150 days for 98%). Could be any day. Remember, FDA will not sit and wait till september 5th once review is done. They will fax it and news will be released during trading hours(I wish).
I. REVIEW PERFORMANCE GOALS--FISCAL YEAR 2008 THROUGH 2012 AS
APPLIED TO RECEIPT COHORTS
All references to "days" mean "FDA days."
A. ORIGINAL PREMARKET APPROVAL (PMA), PANEL-TRACK PMA
SUPPLEMENT, AND PREMARKET REPORT SUBMISSIONS
FDA will issue a decision for 60% of non-expedited filed submissions within 180 days, and for 90% within 295 days.
B. EXPEDITED ORIGINAL PMA AND PANEL-TRACK PMA SUPPLEMENT
SUBMISSIONS
FDA will issue a decision for 50% of expedited filed submissions within 180 days, and for 90% within 280 days.
C. PMA MODULES
FDA will take action on 75% of PMA modules within 90 days, and on 90% within 120 days.
D. 180-DAY PMA SUPPLEMENTS
FDA will issue a decision for 85% of 180-day PMA supplements within 180 days, and for 95% within 210 days.
E. REAL-TIME PMA SUPPLEMENTS
FDA will issue a decision for 80% of real-time PMA supplements within 60 days,and for 90% within 90 days.
F. 510(K) SUBMISSIONS
FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.
Read Section H. INTERACTIVE REVIEW in the document, link has provided below, Above information also has been taken from the same document
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA
I can't do DD for every question you ask for. Ask yourself this question , dig yourself in company's newsletters and go back to messages posted during that time frame in this board and find out an answer and let me know. And then, I tell you whether you are right or not?
Answer: From the newsletter in August'08
Some have wondered why we haven't begun marketing the Dominion Vi Scanner under FDA IDE regulations. Doing this would not be in the best interest of the company as we would be locked into a process that could last many years and should only be considered as a last resort. Many medical device manufactures that have taken this path typically have done so only because their devices were so unique they had nothing on the market to compare substantial equivalence. Under IDE regulations the device being marketed cannot be sold, it cannot generate revenue for the medical facility or physician and can only be used on specific patients and used for specific procedures under stringent guidelines. By marketing the Dominion Vi Scanner under IDE we could not generate any income or profit for the company and only add substantial costs
If I have a few FDA 510K clearances under my belt already and the longest one took only 9 months, I wouldn't be looking for outside conultant to get clearance. 09' was totally dead in the water. There was no interactive process. Do some research in 08' and 09' radiation emitting devices cleared by FDA.
8 points:(actually I have more - no time. get into work)
1) FDA was very slow & cautious & reluctant in approving radiation emitting devices in 08' and 09' due to Media
2) Only Big Boys were approved. Not medium sized or small sized company.
3) There was no interactive process.
4) O-arm x-ray volumetric imaging was only approved which was not real time.
5) Real-time photo-flurography high resolution images - nobody is out there in the market.
6) mobile CT will be obsolute & o-arm volumetric x-ray imaging will be obsolute in the near future - Lot of big companies are already in the process of moving to photo-flurograpy volumetric imaging/ real time/high resolution.
7) IMGG only has patent on this.
8) IMGG will be bought out pretty soon after approval.
IMGG 510k is in interactive process.
- FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.
- Since April 5th submission lot of communications between FDA and IMGG. FDA never put a hold on review clock since April 5th. All are informal request/response. No AI formal letter.
- Read the interactive section in the below link to learn more.
- Based on my research, Final decision after the final response varies between 15 days to 45 days(after july 5th response). So approval could come any day in following days.
- All the things are aligning now towards the approval news.
- Buy and Hold or accumulate/average down and be in stock.
- Don't listen to basher or even to me except your own DD/research.
- Whoever is doing bashing now, either they do flipping on their tradeable shares or shorting. But still maintaining their core positions.
- Play safely. Whoever is down 50% and above, after the approval news the stock price will skyrocket.
- People say, there will be sell off due to PPM shares after the approval, no it is not. Lot of PPM share holders know that this company will be sold out for huge premium between 6 to 8 $, they are not selling. The stock price went down due to orchestrated bear raid by some well known sites. They do this constantly to buy cheapies from panic sellers.
- FDA is in final stage of the review process(performance data review/radiologist review comparison)
- Mark this post. Approval is before September 5th(150 days for 98%). Could be any day. Remember, FDA will not sit and wait till september 5th once review is done. They will fax it and news will be released during trading hours(I wish).
I. REVIEW PERFORMANCE GOALS--FISCAL YEAR 2008 THROUGH 2012 AS
APPLIED TO RECEIPT COHORTS
All references to "days" mean "FDA days."
A. ORIGINAL PREMARKET APPROVAL (PMA), PANEL-TRACK PMA
SUPPLEMENT, AND PREMARKET REPORT SUBMISSIONS
FDA will issue a decision for 60% of non-expedited filed submissions within 180 days, and for 90% within 295 days.
B. EXPEDITED ORIGINAL PMA AND PANEL-TRACK PMA SUPPLEMENT
SUBMISSIONS
FDA will issue a decision for 50% of expedited filed submissions within 180 days, and for 90% within 280 days.
C. PMA MODULES
FDA will take action on 75% of PMA modules within 90 days, and on 90% within 120 days.
D. 180-DAY PMA SUPPLEMENTS
FDA will issue a decision for 85% of 180-day PMA supplements within 180 days, and for 95% within 210 days.
E. REAL-TIME PMA SUPPLEMENTS
FDA will issue a decision for 80% of real-time PMA supplements within 60 days,and for 90% within 90 days.
F. 510(K) SUBMISSIONS
FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.
Read Section H. INTERACTIVE REVIEW in the document, link has provided below, Above information also has been taken from the same document
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM109102.pdf
Thanks Guru & King for the great work you have been doing for this board. Keep up the good work. MM's are sucking the cheepies. They know it it's worth over 500% and more. Stop losses will not work for fda plays and will be taken out by MM's. They can see the stop losses order in Level 1 and can literally manipulate the price to walk it down to grap cheepies. use the mental stop. At the end of end of race, Make yourself available in holding the stock. Think like MMs to accumulate the shares. The race is not over until we win.
Bust, Thanks for everything you are doing in this board Man. Keep up the good work. If you need any kind of help in researching related to IMGG, I will be happy to help you and the board. Once again, you are doing excellent job. Thanks.
Guru, You are The Man, Thanks. Go Imgg!!! Get the damn approval. Herd will follow.
Answer: From the newsletter in August'08
Some have wondered why we haven't begun marketing the Dominion Vi Scanner under FDA IDE regulations. Doing this would not be in the best interest of the company as we would be locked into a process that could last many years and should only be considered as a last resort. Many medical device manufactures that have taken this path typically have done so only because their devices were so unique they had nothing on the market to compare substantial equivalence. Under IDE regulations the device being marketed cannot be sold, it cannot generate revenue for the medical facility or physician and can only be used on specific patients and used for specific procedures under stringent guidelines. By marketing the Dominion Vi Scanner under IDE we could not generate any income or profit for the company and only add substantial costs
If I have a few FDA 510K clearances under my belt already and the longest one took only 9 months, I wouldn't be looking for outside conultant to get clearance. 09' was totally dead in the water. There was no interactive process. Do some research in 08' and 09' radiation emitting devices cleared by FDA.
8 points:(actually I have more - no time. get into work)
1) FDA was very slow & cautious & reluctant in approving radiation emitting devices in 08' and 09' due to Media
2) Only Big Boys were approved. Not medium sized or small sized company.
3) There was no interactive process.
4) O-arm x-ray volumetric imaging was only approved which was not real time.
5) Real-time photo-flurography high resolution images - nobody is out there in the market.
6) mobile CT will be obsolute & o-arm volumetric x-ray imaging will be obsolute in the near future - Lot of big companies are already in the process of moving to photo-flurograpy volumetric imaging/ real time/high resolution.
7) IMGG only has patent on this.
8) IMGG will be bought out pretty soon after approval.