5 Analysts Median Estimate 16$ (174.44% increase from 5.83)

http://markets.ft.com/tearsheets/analysis.asp?s=xoma


The 5 analysts offering 12 month price targets for XOMA Ltd (XOMA:NMQ) have a median target of 16.00, with a high estimate of 36.00 and a low estimate of 8.00. The median estimate represents a 174.44% increase from the last price of 5.83.

what is the link?

Wow!!! Huge Applause and Standing Ovation for you Lob!!!

Yes dude since Dean couldn't choose right PPM investors earlier. You know what I am talking about...Lol!!!
But time has changed. Now He doesn't need those. He is in good hands who are willing to pay/invest over 27cents/share.

Tattooed, I was just answering/joking Boxy's regular sarcastic comments. That was not true. But I heard from someone saying that Dr. Polk did a some kinda valuation with some CPA to figure out how much Imaging3 and dominion worth after the clearance. It was close to that figure. But that figure was estimated earlier when outstanding stock was around 250 million.

if you expect some cadavers testing with dominion in RSNA booth, you may need to do brain scanning in 3D with Dominon. And that too if Dean allows it. Lol!!!

No, 1000's of orders already there. He can't sell it until clearance given.
His estimate is that stock should be traded 500 Million $ to 1 billion $ before the pre-approval.
When the buyout comes, all these leads/orders will be factored in to figure out what could be the best deal.
Medtronic screwed up with their breakaway imaging device/deal. So many problem in there. Dean already predicted that 2D display freeze issue. Remember about the recent FDA RECALL OF Medtronic o-arm device. I expect stock will be traded over 1$ once the filing takes place. This time clearance will be lot sooner since most of they gone thru the complete 510k review cycle already. They need to provide agreeable explanations/clarifications to the outstanding questions listed in the letter.

Dean mentioned 1000's orders already there for DVIS in conference call for shareholder's questions. That is public info.
What you are saying is message board info.
Tell me who to believe in real mind?

So you have been there and you know everything about RSNA. Tell me more.

Seems like week hands out and expect steady flow of buying will occur and uptick in price towards the news announcement of filing. This time with greater support of Mcdermott and expect that this will be done in before first quarter 2011 and even sooner.

You can't get the price any more. bid is moving up and in coming days I expect update on time frame for the FDA pre-submission meeting/filing, More marketing leads and sales orders during the RSNA and More face to face conversational update on the DVIS FDA reviewer's insight.

No need or requirement/regulation for FDA to review the Machine or inspect the facility under the 510K. Applicant submit the truth and accuracy oath letter as part of their 510k application which encapsulates the integrity of the data submitted. Deans goes to jail and spend life time if that is not true in the court of law.

- No PMA
- No de nova
- No clinical trials
- No radiology panel devices under class III 510k
- Reputed FDA attorney is backing up upcoming application.
- if they are able to schedule a pre-submission meeting, that is well and great.
- Private institution invested already. More they are willing invest if it is needed.
- Dean was able to meet the same Reviewer face to face in the RSNA.

I don't need anything else. I am happy with the way Dean is move forwarding.

if the NSE letter did not indicate about de nova or pma, it will list out all the unresolved deficiencies for which the case was issued as decision as NSE. Dean talked about few items in the conference call. Now, FDA law firm looked at it. They are telling the same. I am so happy to hear about that it does not require pma or de nova or clinical trials required. Soon it will be cleared.

Yes My average cost is way higher at current share price. I am at lose too. But My DD about this company & product is pretty good. I will not move on until Imaging3 will be bought out for over 5$. It could happen Next quarter.

I still see the NSE as a positive thing for couple of reasons.

- I can take advantage of the discounted price to add more to reduce the cost average since my goal on this stock is pretty clear.
- Now Dean really wanted to get this done thru experts. He could have done it earlier. But this is what it is. Don't blame him for that. I accept him as he is.
- I am very clear that it is not class III 510k, pma or de nova and it is class II
- Now the application has been drilled down to very few questions & concerns& unresolved issues.
- Reviewer cannot BS it this time around since we have the support of a man worked for 17 years with FDA and his association with the well reputed firm.

What is that you are talking about. Yes he had a good relationship with that reviewer earlier through interactive review process (email/phone conversation) It doesn't mean that he saw that man earlier physically. Now he has seen him physically which is a good news. The people who like to hide themselves behind the bogus id's never reveal their identity physically or face to face since they and their hidden/dubious agenda will be exposed.

NSE code is for the FDA's internal purpose based on my research to notify the final decision maker(division device head) from the reviewer. But NSE should outline what is missing? Here in this case looks like lack of data based on Mcdermott.

- Financial information is irrelevant for a junior biotech/pharma/medical device company as long as they achieve their milestones.
- They had 510k IDE approval in 2008
- Filed 510k last year, FDA will follow the flow chart of decision making process, first they do check on the intended use/labelling info, they came up with that. Imaging3 rectified it and sent the info. Reviewer/review team change(organizational change within FDA happened. The new reviewer team came up with some more clarifications and questions and required radiologist review)
- They came up with questions and radiologist review data, Imaging3 submitted. Due to lack of data they issued NSE. I believe they want to see additional date(not a clinical trial, see my other post, also NSE letter should point out if it is PMA or de nova) The FDA man (16 years experience with FDA) reviewed it and confirmed that it doesn't require pma or de nova(see also my earlier post on why it is class II 510k)
- Now the statistics say that 3rd party reviewer approves 37% of the radiology panel devices from 2003 thru 2007. it is upto mcdermott now whether they can handle it on their own. or set up a face to face meeting with fda to figure out whether 3rd party reviewer is needed or not.
- Dean met imgg 510k reviewer in the RSNA which is a good news too.
- once they submit new 510k after they meet with fda(personally I believe it is not needed), I expect the approval could come soon since it is going to be same package and most of the questions answered and unanswered questions will be taken care with the new filing.
- I expect this time approval come soon.

http://www.foiservices.com/brochure/devicedocs.cfm#510k


510(k) Notifications

Manufacturers of devices believed to be non-critical and substantially equivalent to devices manufactured prior to 1976 may submit a pre-market notification outlining device specifications and characteristics. These notifications, usually called 510(k)s because they are regulated by section 510(k) of the Medical Device Amendments, are reviewed by the FDA. If, after review, the FDA agrees with the manufacturer's determination, the device can be marketed. Substantial portions of the 510(k) are available through FOIA once an Agency decision has been reached.

Since 1976, over 76,000 510(k)s have been cleared for marketing. Although substantial portions of the 510(k) are available using the Freedom of Information Act, there is often an 18 to 24 month backlog in FDA's processing time for these requests. With over 35,000 510(k)s on file, FOI Services can often provide a 510(k) immediately.

http://medicaldeviceschool.com/fda%20510(k)%20submission.html

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. Detailed information on how FDA determines substantial equivalence can be found in the Premarket Notification Review Program 6/30/86 (K86-3) blue book memorandum.

Until the applicant receives an order declaring a device SE, they may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. If FDA determines that a device is not SE, the applicant may resubmit another 510(k) with new data, file a reclassification petition, or submit a premarket approval application (PMA). The SE determination is usually made within 90 days and is made based on the information submitted by the applicant.

No clinical Trials required for 510k Radiology panel(example-imaging devices category)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

Search with Radiology panel and clinical trial yes. you will find none. so, dominion is clearly does not require clinical trials.

Radiology panel review devices are not class III 510K devices

Please see the below link:
NSE WHY?


From page 51
Class III devices approved from 2003 thru 2007
?Medical specialty Frequency Percentage
Cardiovascular 64 28
Orthopedic 54 24
Gastroenterology
and urology 36 16
Dental 31 14
Physical medicine 19 8
Neurology 14 6
Microbiology 7 3
General and
plastic surgery 2 1
Obstetrics and gynecology 1 1
Total 228 100


Conclusion: Dominion is not class III 510k type which obviously indicates it is not PMA for sure. No clinical trials required based on the above search in fda website with clinical trials required YES and radiology panel.

So Dominion is clearly a 510k class II type. See the figure 10 in the above PDF for the decision making process

From the same document:
More Than Half of the 510(k) Submissions FDA Determined Not Substantially Equivalent Were for Devices That Had a New Intended Use or New Technological Characteristics
We also found that about one in every three 510(k) submissions FDA determined to be NSE had the same intended use and the same technological characteristics as the predicate device, but FDA determined the submissions NSE because of a lack of performance data.

http://medicaldeviceschool.com/fda%20510(k)%20submission.html


A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. Detailed information on how FDA determines substantial equivalence can be found in the Premarket Notification Review Program 6/30/86 (K86-3) blue book memorandum.

Until the applicant receives an order declaring a device SE, they may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. If FDA determines that a device is not SE, the applicant may resubmit another 510(k) with new data, file a reclassification petition, or submit a premarket approval application (PMA). The SE determination is usually made within 90 days and is made based on the information submitted by the applicant.

No clinical Trials required for 510k Radiology panel(example-imaging devices category)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

Search with Radiology panel and clinical trial yes. you will find none. so, dominion is clearly does not require clinical trials.

Do me a favour. Go to fda site for 510k search, if you choose radiology and clinical trial - yes, you will not find any SE determination. in other words, in the past all the radiology devicess which don't require clinical trials for 510k submission. That is obvious and black and white. Please post with facts.

- class II devices which require clinical trials are Gatronology, neuelogy, some of opthalmic, etc.

Not a single device in Radiology departments. Read and learn.

That means you are wrong and you are missing info. Go back to my earlier post which has got some links about the appeal process and go back to Emperor Joe Bary and KK_GURU's research on 3rd party reviewer. It can be filed again even under de nova category. See earlier Mugs post yesterday I believe. Lot of avenues there. DVIS will get approved.

Bid is moving up again. MM's made as usual grabbed cheepies by panic/nervous investors/traders. Congrats to buyers who did a bottom fishing at 8 to 9 cents range.

Nope. That means you didn't do your DD. Dean always believe that it is a 510k clearly. I also believe that. I slowly started agreeing with Shaka on his earlier cry on Software couldn't be substantially equivalent. But I could be wrong. DVIS is clearly a 510k product since it is doing scan and construction in a faster pace. other predicates are like medtronic o-arm. Don't know whether Dean was able to prove the software is substantially equivalent to other traditional PACS system which is available in the market.

You are lucky and I don't have powder and wait till tomorrow for the funds to get cleared.

Nope, Polk is holding 5 million shares and bought thru ppm activity earlier on and still holding as for as I know. He may be wrong in his expected date of fda decision. Go to his site and read about him. Though, Dean has 2 FDA clearance in his career, he doesn't know much on the recent FDA MDUFMA goals and changed approval process on 510k after 2007. He needs to hire 3rd party accredited reviewer as Joe and Guru suggested earlier. Dean has to get a help from Polk and Wharton and other big guns to proceed further thru appeal process or whichever is better.

I don't agree with that he is good business man too. But he is an innovator and now he is in listen mode what the longs/shareholders expecting from him. Hopefully all is well thru 3rd party review.

Nope...watch out for press releases about the appeal process and/or 3rd party review...expect the quick turn around in the stock price soon.

weekhands left. bid is moving up...

Wharton is buying at more than 60% discount price now.

MM's scare tactics. Don't fall for that.

Buy the cheepies if you can, Dominion will be approved thru 3rd party reviewer/appeal process in few months.

Don't be a dump at selling at this level. wait it out and watch for the develepments.

Appeal process continued...

http://newsblaze.com/story/2008100705002300001.pz/topstory.html

Appeal process - continued
http://www.regenbio.com/media/The%20Gray%20Sheet%20PDF%20for%20posting.pdf

An example of appeal process from 2006
http://www.regenbio.com/switzerland/en-int/pressroom/572/regen-biologics-announces-results-of-fda-appeal

Go to KK_GURU's earlier report. it is black & white. In 2010, The product codes he listed (department radiology) have been getting approvals. Not the way you see or say. Do some good DD. Post with the facts/links. Good for the board.

Wow!!! Great Post!!! Nobody can come closer to Guru's Fact based DD. I would strongly recommend all the board members, watchers, whiners, frustrated longs to go back to KK_GURU's earlier posts to get a feel about how FDA is operating, what's DVIS Dominion worth about.

5$ PLUS

I disagree. In the shareholders conference call, company's website, 8k and 10k filing, proxy statement, all the SEC filings, money tv interviews, other interviews with investors journal, it has been clearly mentioned that in black and white Dominion Dvis is the only one machine which is producing REAL-TIME 3D images for the diagnostic procedures. Dean can't lie about that. if SEC finds that he will have to spend the rest of his jail. He is not hiding like you, behind a bogus id. In the last conference call, he has answered very clearly & precisely that Dominion can go to production from the day 1 after the FDA clearance. I believe strongly that he has done everything he can to bring this game changing & revolutionary & patented (40 claims) to the market. It is not the thermometer, you bring into the product. Anybody who buys Imaging3 could grab over 10 billion $ market in couple of years. You can't get this price once it gets approved. gap up will be in the $ 1.20 to $ 1.50 range. And it is going to be multi-day run. it is not the pharma play with the set date for the binary event. The news may hit any day and any time. it is Either you in or out. I expect stock will stabilize in the over 2-50 to 3-50$ range. Buyout could be over 5$ range.

Dean is a very postitive and optimistic man. He could have slipped or wrongly forecasted some of the things in the past. It is not going to alter the fact that DOMINION is going to rule the medical imaging market in the near future.

You try to show Dean's earlier posting and try to implement your hidden agenda of buying shares with less price. That will not happen. You waste your time and energy on that. Be well.

Thanks Guru for the flow chart.