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Anyone holding HDC shares may wish to act?
•From Bill Quirk
Fellow HDC Shareholders,
Our Company is in very serious financial difficulty right now and I believe that CEO John Norris must be terminated in order to avoid disaster. There are two major "inflection points" in the immediate future that I expect will determine whether HDC survives or dies: the expiration of Mr. Norris's employment contract in mid-June and the election of directors at the Annual Shareholders Meeting in late June. As a practical matter, shareholders ordinarily have no influence in deciding such issues. However, because of a non-recurring set of circumstances, I believe HDC's shareholders now have an opportunity to speak with a loud voice in helping to save our Company.
The first thing I want to discuss is Mr. Norris's employment with HDC and why he must go. In a nutshell, he has never performed and is overpaid at any salary, much less the outrageous one he's now getting. Mr. Norris joined HDC almost 4 years ago with the express task of generating revenue in the health field. His "pitch" back then was that his contacts from his days as the #2 guy at the FDA would pay off big time for HDC. In his 40 months as a VP, his track record was unblemished by revenue. That is to say, he produced exactly zero revenue. Nothing. So, in November 2012, after costing HDC about $400,000 plus benefits over that time and producing nothing, Chairman McKenzie informed me personally that Mr. Norris would be fired. But it didn't happen. Mr. Norris visited Savannah to see Chairman Mckenzie and apparently persuaded him that his non-performance was all due to the former CEO but that with himself as CEO, he could really show his stuff. So Chairman Mckenzie put him and his colleague Mr. Takeichi on the Board and gave him a "short-leash" 6-month contract based on his representations that he needed that time to raise large sums of money from one or more major Japanese firms with the assistance of Mr. Takeichi. Mr. Norris went to Japan three times and three times he returned empty-handed. The Japanese initiative did not succeed and it never will with Mr. Norris in charge because he simply does not have the mojo to accomplish this, much less run HDC. In brief, Mr. Norris has failed.
However, one thing Mr. Norris has excelled at is endorsing his paychecks. After his almost-firing, in the 6 months from December through June 2013, Mr. Norris will have collected about $175,000, plus benefits and stock, and this from a company that has been hemorrhaging cash. He has also been quite generous with two favored consultants, with monthly outlays that may run as much as $30,000. They too have produced zero revenue, and as both are semi-retired and qualify for Social Security and Medicare, this is a great gig for them. At the same time, cash that could have been utilized productively in certain promising areas within HDC has dried up because "austerity" in these areas is necessary for the gravy train to keep running. And how does HDC pay for all this largesse? By selling Neogenomics stock, the only source of cash. So, what's going on here? How come big pay for zero performance? The following may be illuminating.
In January 2013, shortly after Chairman McKenzie and director Fritsche handed the reins of HDC to him, Mr. Norris sent an email to HDC'ers. In the most stunning example of hubris I've ever seen, he grandiloquently declared, in print, "The King is dead, long live the King". When one has witnessed firsthand, as he did, the attitude of entitlement, entrenchment and enrichment that characterized the Long Nightmare, it's not surprising that a bit of this might rub off on a new regime. Boy, did it! When one considers oneself "royalty", it is difficult to reconcile such an exalted self-image with the notion of fiduciary responsibility to one's subjects. Mr. Norris has not been able to do this because when one doth bestride the narrow world of HDC like a colossus, we, mere mortal shareholders, must pay homage and criticism begets a predictable response – or worse, as in this case, silence – from the castle. Kings, of course, are accountable only to themselves.
Even this would be easier to swallow if any of his ideas were earthbound and had a snowball's chance in summertime Savannah of realization. But they aren't and don't. He is living in a fantasyland of daydreams so grandiose that even HDC's insiders snicker and comment derisively. Imagine how anxious executives at other companies are to do business with a philosopher-king whose business strategy is little more than waiting for the Bluebird of Happiness to fly in over the transom and drop a bag of gold on the table.
Mr. Norris has failed by every objective measure and has to be terminated, and if he doesn't go, HDC is toast because he'll spend us into oblivion. Case in point: in the first 3 months of 2013, HDC cash expenses were $634,000, including $445,000 in salaries and consulting fees, and dividends were $34,000, a total of $668,000! Spending of this magnitude at a time when HDC is sliding towards insolvency is profligacy, it is madness and it has got to stop. Mr. Norris is out of control and cannot be trusted to take responsible and timely action to save HDC.
Here's what has to happen for HDC to have any chance at survival. The Board must terminate Mr. Norris's employment at the expiration of his 6-month contract in mid-June. That was the deal he and HDC agreed to in December; he was on a short leash on purpose because of his prior 40 months of utter non-performance. So I don't want to hear, "Oh, we were just kidding". No second chances, no severance, no stock, nothing. Just "Good try, goodbye". HDC is not some "Big Corp" that can ease the sting of termination with money. HDC is in extremis, bleeding cash and in very real danger of failing if strong action is not taken right now.
As it turns out, the authority for this crucial decision lies solely with Chairman McKenzie and director Eckoff. Fortunately, Mr. Norris's contract expires a week or so before the Annual Meeting when new directors may be elected. While director Takeichi would surely vote to renew his friend Mr. Norris's contract, Mr. Norris himself cannot, by law, vote on any matter that would benefit him personally. So the issue will be decided in a 2-1 vote a week before the Annual Meeting. If either Chairman McKenzie or director Eckoff votes to renew Mr. Norris's contract, it's a done deal and we're stuck with him until the gavel comes down on the courthouse steps.
Yesterday, former Secretary of Transportation and Secretary of Commerce Norman Mineta joined HDC's Board at the invitation of Mr. Norris. Secretary Mineta is a superb addition to our Board. But because he is so new to HDC, he should recuse himself from this vote because he has no personal knowledge of Mr. Norris's grossly unsatisfactory performance as HDC's CEO. It would be a sad postscript to Secretary Mineta's illustrious career and a wholly unnecessary risk to his reputation and legacy if a well-meaning but inadequately informed vote by him to renew Mr. Norris's employment contract led to HDC's bankruptcy while he is a Board member.
You'll not find it surprising that as HDC's largest shareholder, I have sounded out a variety of people about the dire situation at HDC. All have told me that they would not consider serving as CEO or as Board members or involve themselves in raising any capital as long as Mr. Norris or any member of the current Board remains. That, of course, excludes Secretary Mineta who would be greatly welcomed as a key member of a working Board tasked with getting HDC out of this mess. This is called a clean sweep. And it is long overdue. While there may be different roads to get there, this must happen if HDC is going to have a chance at survival. So, I think it would be a disaster if a new slate of directors unacceptable to me appears on the proxy statement, particularly any of Mr. Norris's cronies. It's up to Chairman McKenzie and director Eckoff to figure this out and get it done. And it must be done quickly because time too is our enemy.
It's easy to criticize but hard to build. What I would do is set the goal of selling or merging our entire Company, not just some assets, by pursuing a strategy and policies generally along the following lines. When could this happen? It's impossible to tell right now but one thing is sure: HDC simply should not be a stand-alone public company. These are some of the priorities as I see them.
• explore minimally minimally dilutive financing alternatives
• begin to develop "Big Data", which capitalizes on the intrinsic strengths of our SVM IP.
• explore the potential for a JV partner to finance and manage patent litigation against infringers
• focus attention on smaller Asian firms seeking a toehold in the U.S. market
• continue to nurture and develop the superb Neogenomics relationship
• undertake to monetize SVM Capital
• eliminate employment contracts and have officers serve at the pleasure of the Board
• institute both austerity and very generous pay-for-performance policies
In January 2011, I presented the Board with a plan to begin to position HDC for sale or merger. The Board flat out refused and the Long Nightmare became longer and darker. HDC should not be a public company because it does not have a critical mass of management and revenue. HDC does have legitimate patent assets not reflected on the books whose value is much greater to larger firms with the financial, managerial and intellectual resources to fully exploit them internally, defend them from infringement (and HDC's are widely infringed) and present their practical applications to other companies that prefer to deal with a sizable, credible enterprise rather than a tiny firm that may not be around in a week. In fact, specific to that point, I was told that HDC once lost a huge opportunity with GE Healthcare Imaging when GE's CEO Jeffery Immelt (yes, apparently it got up that high) vetoed the deal because HDC's microscopic size denied business credibility and staying power. Our science was there and was real and could have advantaged GE Imaging in a very competitive market. But the perception of dealing with a "real" company wasn't.
That can't and won't change. But my idea is to position HDC as a coherent collection of intellectual assets that have practical commercial utility in a number of different applications and that can be exploited far more profitably by larger companies than we ever could, and thus have HDC viewed as a potentially attractive asset within another enterprise.
That's the plan. But it will never get to first base if Mr. Norris manages to hang on to his gravy train, even a little bit. So, what can you, fellow shareholder, do? Email Chairman McKenzie and director Eckoff and tell them to "get it done". And contact any HDC shareholders you know and ask them to do the same. You can even post this letter on message boards like Raging Bull, Yahoo! and iHub. There is not much time and if you're going to do anything at all, please do it ASAP.
Sincerely,
Bill Quirk
10-Q yesterday 5-15-13
Note H – SUBSEQUENT EVENTS
On May, 10, 2013, Secretary Norman Mineta agreed to join the Company’s Board of Directors. Norman Mineta, vice chair of public policy at Hill+Knowlton Strategies, former U.S. Secretary of Transportation and former Secretary of Commerce, provides counsel and strategic advice to clients on a wide range of business and political issues. Secretary Mineta is well known for his work in the areas of transportation—including aviation, surface transportation and infrastructure—and national security. He is recognized for his accomplishments in economic development, science and technology policy, foreign and domestic trade, budgetary issues and civil rights.
In connection with his appointment to the Board of Directors, the Company will grant to Secretary Mineta an option to purchase 1,500,000 shares of the Company’s common stock. The options vest 250,000 shares every six months, have an exercise price of $0.048, and expire on May 10, 2023. The fair value of each option granted is $0.035 and was estimated on the date of grant using the Black-Scholes pricing model with the following assumptions: dividend yield at 0%, risk-free interest rate of 1.91%, an expected life of 5 years, and volatility of 97%. The value of these options is $53,017, and this amount will be charged as an expense over the three year vesting period.
Close encounter of the 3rd kind in web link as follows
http://www.hkstrategies.com/sidebar-video/291
Intellectual Property Developments
Currently, the Company holds the exclusive rights to 57 issued U.S. and foreign patents covering uses of SVM and FGM technology for discovery of knowledge from large data sets. The Company also has 23 pending U.S. and foreign patent applications covering uses of the SVM technology as well as biomarkers and diagnostic methods that have been discovered using the SVM technology. The reduction in the total number of issued and pending patents during the past year resulted from the Company’s decision to allow certain foreign patents issued and/or filed in countries that were deemed to have lower strategic value to lapse. This in turn reduced the Company’s total expenses for patent maintenance.
Intel
In October 2012, the US Patent and Trademark Office (“USPTO”) issued a reexamination certificate for Intel’s U.S. Patent No. 7,685,077, which issued in 2010 with claims covering SVM-RFE. The reexamination certificate confirms the patentability of the claims as amended during the reexamination proceedings.
While disappointed with issuance of the reexamination certificate, the Company draws encouragement from the fact that the USPTO has agreed that all elements of the Company’s patented SVM-RFE method are present in the Intel claims. A fundamental principle of patent law is that the addition of one or more elements to a patented claim does not avoid infringement. In this case, Intel merely added a standard computer operation to the Company’s SVM-RFE method. Furthermore, possession of a patent on series of steps does not avoid infringement of a patent covering a subset of those steps.
The Company submitted a request to the USPTO to initiate interference proceedings once the reexamination certificate was issued and has subsequently received a final rejection in the application that was filed to provoke the interference. The reasoning behind the rejection has been uniformly criticized in decisions by both the Patent Office Board of Appeals and the Federal Appeals Court in cases with nearly identical facts. A response referring to these decisions has been submitted to the USPTO, and reversal of the rejection is expected, although the USPTO has yet to act on this response.
It does appear that the involvement of Mr. Norman Mineta to the board could be very helpful depending upon his involvement and contacts. There is a link above to hear a few things from him.
As for our Intellectual Property by also viewing our past 10-K you will find that 10 patents are involved in the reduction of up keep expense. I will not define this but would imagine that we may have even lost SVM from China. If this is so and can be seen in the near future I would then bet that it can be related to the patent Intel has in China. I hope this is not so but listen! We are in survival mode regardless what the company pays themselves.
As seen in past threads it looks as though HDC did lose. It even seems that the patent office doesn’t even want to talk to HDC. Is it true that HDC did mess up to the point we are finished involving any request or future fight for rights? Again we are in conserve mode and it can be seen but I sure hope HDC doesn’t use that excuse for s forever period of time.
This is where things can get really tricky. The power in and around Quest, Abbott and the FDA. Grant money, things that each organizations wants, What does our congressman or Senator want?
When it may come to pushing the PSA test out of the way who are we pushing on????? I will guarantee you someone or some entity will push back and do it in a way that is hard to see, delays FDA processes etc, etc....follow the money.
Please keep on topic ; )
Karl, I like your ideas and think you are on track, I do hope they are able to couple the impact of both products to have one heck of a market run in the near future like prior Septembers warrants :)
Correct and an early buy out is forced upon us due to our own intolerance. So what that means is we won't be bought out at a high premium share price as we would like.
No doubt I agree but when people talk about Vermillion it isn't as though many retail investors were able to come on board for that ride. With a close look at all that when their share price flew like a rocket their were only around 4.5 million shares outstanding and with even less shares in the public hands why my GOD that share price had to rocket into the high $20's and then low $30's before falling out of the sky over the next two months but yes bring it on and let us share some glory with seeing a substancial share price move. I hope this is readible as I can hardle see the monitor due to a sickness I hae. I must close right this second
Please stop worrying. We are all set, we are just waiting on Quest Diagnostics and nothing more. Honestly, it is as simple as that.
Tryn2, within the past 10-Q filing and the recent 10-Q/A the only difference between these two filings is the fact that the no named party in the earlier 10-Q is now named. The 10-Q/A filing on 2/11/2011 released the name of "Prime Mover Capital Partners" in the Settlement & Release Agreement from 7/27/2010.
Dollardaze, Yes Prime Mover Capital has sold their position in HDVY or at least this is how I'm seeing it?
Looky at this... am I seeing things or what? Did GSK - GlaxoSmithKline actually go through with selling their 15 million share position in Quest Diagnostics a few days ago? Is this true or am I seeing things that aren't there again?
I've been pretty much wrong lately so don't mind me.
Tryn2 my laser is basically done with HDVY'S latest 10-Q/A and the Exhibit starting with 10.1 and so forth. We are talking roughly 58+ pages involving all this. I will let you know about any differences after I compare all the documents. I will probably give you a thumbs up tomorrow some time depending on what my health.
Please stay on topic, I know there are only a few posters now days and we don't want to push posters away but if I don't do my job IHUB will only jump on us that are moderating.
Contact IHUB you feel your message was removed without merit, Thanks, Bob
As far as I see those two post are a great reason that SVM and multiple SVM machines are to be "thee" state of the art answer that corporations are looking for and soon enough they will come a knocking....just like "Quest/Abbott" No doubt at all!
No news today? I must have mixed up my days, or were they talking about tomorrow! yeah!!!.... thats it...tomorrow!
Glad to hear that you just keep up with the positive values and you will see much more in the days and weeks to come.
It sure looks like we will have some news today.
AccipiterQ, I am glad HDC (our company) is able to show you and the non believers.
Norton, hope all is well with you, maybe this is your year?
Steve, I don't think we are that far from hearing some news referencing the double blind testing results but do feel Quest will first need to reavaluate with HDC then fine tune any contract differences before actually making any announcements.
If you have more share than the 6 of the top insitutionals than you know as we do why we don't wish to sell them.
I can assure you that Dr. Barnhill would not have hired the Dilenschneider group for nothing. I would firmly state that massive money has moved in buying and selling HDVY share a year ago or so. They are not just some company that would promote HDC with press releases they are a company that would go after bigtime investors and steer them into buying stock here plus portfolio investments. You hire the best and forget the rest!
I know you love this company but do you really feel as though we would be satisfied with news from another front and not of the meat and potatoes? I doubt that very much and besides the company is small and focused on the end of a pin, much time is needed for Quest NOT HDC. Everything to me seems hinged on the success or failure of the double blind tests...let me just add, it may be a double blind test but I am not blind nor worried any longer. Now this doesn't mean that the test will be successful when it is completed but as I said it isn't completed!
Hello King, no doubt I felt that way prior and you know I had various feeling about this investment after 7 plus years. Well that has all changed. Please note the only sticky posts that remains and it is by Chazzy. I guess one could say seeing is believing, I like that phrase.
Yes Karl you have the correct patent which involves 20-30 bio markers and doesn't seem to use SVM in the process due to another approach.
LTD...is right on the money with his posting about Quest and Abott, wow! what a smart man. At any rate I have no problem with what appears could be a better understanding of the test and technologies along with more time needed for Abbott.
Chazzy, I have been checking the patent differences between what we have and what is now shown on HDC website. It probably is not necessary to change anything yet but it looks like 8-10 differences on the addition/or patents modified and maybe 1-2 that no longer are seen due to the FDA thingy a year or so ago. The recent modifications show interests in the USA, Europe, India Australia, China and Japan and the concentration of the patents here are involving "Flow Cytometry Data" in a big way the same as our powerful SVM patents. The Prostate biomarker patent seems to be right in line too. I wish the company were able to explain in depth just how and why these patents are so important and to somehow show us where we really stand in reference to other competing technologies.
Hey Chazzy, I keep on looking at that too and I hate like heck to think we must keep on pushing the dates back but somehow some way Quirk must know something we don't. I explained prior that Mr. Quirk has made millions already and even so there is no way in heck that he would take a chance in losing out with moving from 32 million warrants to 10 million (basically speaking) warrants without some reassurance. This man knows how to make money and by golly we need to hang in here with the money therefore and overall by September-October Mr. Quirk is thinking that HDVY will have a rise in share price to make him decide to go for it and buy 10 million shares as his warrants are pointing towards! Another problem I worry about and that is does everyone really understands how these warrants work as to say like Mr. Quirk's warrants. I think if we get any takers that ask us in the thread or in private to explain how warrants are exercised or in general, questions as such should be posted in private or possibly in this message board to explain the entire scenario involving warrants, etc.
Chazzy, look at post #9687.eom
AccipiterQ, please don't worry about Tryn2 or myself. We have seen .04 and been there and done that a few times. Also, no one is blaming you for anything so maybe lighten up on yourself. We chose over 7 plus years for this to be our investment and not a typical stock trade. Those that trade stocks do as they do as some of us select a stock or two along the way for a long term shot with no guarantee. By checking a persons past post it is easy to determine if they are invested in any stocks or just basically a trader, simple as that so have a great time trading stocks.
Hello Chazzy, I'm glad you highlighted that portion of HDVY's code of ethics involving their officers. It reassures us that the company keeps abreast of good conduct, reasonable and up to date information be it good of bad and so forth!....thanks again
Health Discovery Corps
Code of Ethics for Chief executive Officer and Senior Financial Officers
This policy applies to all senior financial officers of Health Discovery Corporation (the "Company”). The senior financial officers of the Company include the Chief Executive Officer, the President and General Counsel, and the Executive Vice Presidents (“Covered Persons”).
This Code of Ethics is required by the United States securities laws and the rules and regulations of the Securities and Exchange Commission (the “Commission” or “SEC”) as being necessary to deter wrongdoing and to promote:
(i) honest and ethical conduct, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships;
(ii) full, fair, accurate, timely, and understandable disclosure in reports and documents that a company files with, or submits to, the Commission and in other public communications made by the Company;
(iii) compliance with applicable governmental laws, rules and regulations;
(iv) the prompt internal reporting of code violations to an appropriate person or persons identified in the code; and
(v)accountability for adherence to the code.
As noted above, the Company is required to monitor and audit the effectiveness of this Code. If you have any questions regarding this Code, please refer to your immediate supervisor, or, with more difficult questions, please feel free to contact Mr. Scott Tobin at (912) 443-1987. If you are unable to obtain a response, as a last resort you may bring any matter to a member of the Company’s Board of Directors.
1. Each Covered Person must avoid any transaction or arrangement that would create a conflict of interest or the appearance of a conflict of interest between personal and professional relationships.
A conflict of interest may be generally defined as a conflict between the Covered Person’s private interests and his or her responsibilities to the Company or an entity with which the Company maintains a relationship. A conflict of interest can also arise when an immediate family member is involved in a transaction or arrangement that in any way casts doubt upon the Covered Person’s independence. An “immediate family member” includes a Covered Person’s spouse, parents, children, siblings, mothers and fathers-in-law, sons and daughters-in-law, brothers-in-law, and anyone (other than employees) who shares the Covered Person’s home.
2. Covered Persons may only accept items of nominal value as gifts from the Company or any individual or entity that is involved or seeks to become involved in a business relationship with the Company.
Gifts to Covered Persons must be inexpensive, unsolicited and not given with the objective of influencing the Covered Person’s judgment. It is acceptable for a Covered Person to accept modest meals or other inexpensive forms of entertainment from individuals or entities that are involved or seek to become involved in a business relationship with the Company as long as these items are not provided in order to influence the Covered Person’s business judgment or decision. Under no circumstances is a Covered Person permitted to accept payments, loans, kickbacks, bribes, special privileges or services from anyone. If there are any questions or a borderline case, Covered Persons should discuss them with the Chief Administrative Officer or designee of the Chief Administrative Officer.
3. All Covered Persons are responsible for maintaining accurate financial records for the Company.
Covered Persons must closely adhere to the following accounting guidelines:
(i) All assets, liabilities and transactions of the Company should be accurately recorded in accordance with the Company’s record keeping procedures and generally accepted accounting principles;
(ii) No false or misleading entries are permitted to be knowingly made or caused to be made in the Company’s record books, even if such entries would not be material to the Company or its operations as a whole; and
(iii) Any entries that are inaccurate, false or irregular should be promptly reported for an immediate corrective action.
4. Covered Persons must recognize that confidential information is an asset of the Company, and must refrain from using inside information to their personal advantage.
Covered Persons must maintain the confidentiality of information entrusted to them by the Company or its customers or suppliers, except when disclosure is authorized or legally mandated. Confidential information includes all non-public information that might be of use to competitors, or harmful to the Company or its customers or suppliers, if disclosed.
At its core, the prohibition against insider trading focuses on the buying, selling or trading in securities using non-public information. The prohibition applies to securities of the Company as well as to customers and suppliers of the Company, or any entity with which the Company has a business relationship. Covered Persons should refer to the applicable Company’s insider trading policy for further guidance.
Covered Persons are in a unique position to acquire non-public information about the Company, and such information might influence their decision to buy, sell or trade securities. In addition to refraining from using inside information in making their own investment decisions, Covered Persons should also avoid discussing the inside information with friends or immediate family members (whether at home or in the public) or mailing or faxing the inside information to outside sources unless appropriate confidentiality agreements are in place to ensure that material, non-public information is not used improperly.
5. The conduct of Covered Persons should be governed by the highest standards of integrity and fairness.
Covered Persons should avoid those situations in which outside personal interests conflict with the Company’s business. These situations include:
(i) Ownership by a Covered Person, or a member of his or her immediate family, of a material financial interest in any outside enterprise that is involved or seeks to become involved in a business relationship with the Company;
(ii) Ownership by a Covered Person, or a member of his or her immediate family, of a material financial interest in any outside enterprise that competes for business with the Company;
(iii) Outside employment of a Covered Person, or a member of his or her immediate family, whether as a consultant, director, officer, employee or independent contractor, with an entity that is involved or seeks to become involved in a business relationship with the Company; or
(iv) Appointment of a Covered Person, or a member of his or her immediate family, to a public office, board or commission that may create an appearance of a conflict of interest between the goals and purposes of that organization and the Company’s business. Such appointment would include a “public service” organization or a not-for-profit organization.
6. Covered Persons must not take for themselves opportunities that they discover while working for the Company, or use corporate property or information for personal gain.
Covered Persons must not (a) take personal advantage of a situation or knowledge acquired through the use of his or her position or the Company’s property, if the situation or knowledge could be used for the Company’s benefit, (b) use his or her position or Company property or information for personal gain, or (c) compete with the Company. Covered Persons owe a duty to the Company to advance its interests whenever the opportunity arises.
7. In drafting periodic reports that are to be filed with the Commission, Covered Persons should take all steps necessary to ensure full, fair, accurate, timely and complete disclosure.
(i) Provide Full and Fair Disclosure. Covered Persons should ensure that the Company’s periodic reports convey the full financial picture of the Company to the public in an accurate, timely and understandable manner. A well-written MD&A analysis should be used in order to explain in all material respects the key factors, trends, and uncertainties affecting the Company. Covered Persons should strive to present their analysis of the Company’s financial condition in such a way that average investors would reasonably be expected to understand the importance of the information contained in the periodic reports.
(ii) Make Sure Potential Conflicts are Fully Disclosed. It is important to ensure that any transaction that threatens to create a conflict of interest is addressed in the Company’s SEC filings.
(iii) Regularly Communicate with the Audit Committee. Covered Persons should ensure that accounting standards are being applied uniformly and that the Company’s disclosure is supported by sound judgment and analysis. The Covered Persons, principally the CEO and CFO, shall regularly communicate with the audit committee and address any issues identified by the audit committee.
(iv) Provide Management with Ample Time to Review and Comment on Disclosure Documents. Covered Persons should focus on completing the financial disclosure in periodic reports well ahead of the filing deadlines to allow sufficient time for review by management and auditors.
8. Covered Persons must comply with all laws and regulations that apply to the Company’s business.
All Covered Persons should understand those laws that apply to them in the performance of their duties and ensure that their decisions and actions are conducted in conformity with those laws. Any violation of the applicable laws can subject the Company or the implicated Covered Person to liability. Any inquiries relating to compliance with applicable laws and regulations should be directed to the Company’s President and General Counsel.
I would rather have good or bad news than nothing. As some have mentioned prior, there is more going on than just the Quest/Abbott deals but it looks like the only news we will get will be from our yearly filing in late March 30th-31st.
btw...Chazzy is working on something so hold tight.
Tryn2...how is this for venting a tad bit!
Hey Tryn2....yes the response you had made was about Abbott and their possible 510K FDA Submission guide that I posted. I just posted it I have NOT read one area of the C-1 - C-4 file wording. As for Quest I had already posted exactly why it was possible that we haven't heard from our company but like you I fall directly back to questioning our company and that is the results of the way our company has always respected their public trading shareholders. So you are indeed feeling some pain why I guess so you and I have been here longer than Dr. Barnhill and we are both dam tired of waiting on Mr. money bags to at least treat us shareholders with 1 degree of respect, but I don't see Dr. Barnhill as ever doing so because he has simply told us a time or two PRIOR that he would but from what I have seen he hasn't changed one dang bit. Now maybe if we were to go to a shareholders meeting he might blow some sunshine our way but as you and I know the sunshine trick doesn't work on 7 year bag holders/investors or perhaps that have been here forever or actually going broke in waiting for a return, a response, or for a corporation to simply say we screwed up and then play some Clinton game to say they are sorry. Hey! do you wonder if Scott Tobin may have had the trial samples on the front seat of his car when he was getting gas and when he ran in to pay for the gas someone ripped off our trial samples and the testing never went forward as Quest and Abbott felt we were too irresponsible to do all of this. I have night mares about this...so how am I doing has this calmed you down at all!
This is the FDA Submission Plan that some may wish to view. It was taken from the 8-K filing on 2/5/2009 located within EX10.1, Tiltled; [Exhibit C], [FDA Submission Plan] C-1, C-2,C-3 & C-4
===================================================================
Exhibit C
FDA Submission Plan
Feasibility & Validation Studies
I. Costs and Performance Site for Phase 1 and 2:
Abbott and HDC agree to have the experimental testing of Phase 1 and 2 performed at *, with *, as the principal investigator. HDC already has a experimental testing agreement in place with * that will cover the performance of Phase 1 and 2. HDC warrants that it has the right under the agreement with * to transfer the data resulting from Phase 1 and 2 testing to Abbott and that Abbott has the royalty-free right to use the data in any regulatory submission. Abbott shall be responsible for payment to HDC of *’s actual costs for performance of the Phase 1 and 2 experimental testing, up to a maximum of One-Hundred-Thousand Dollars ($100,000.00). HDC shall be responsible for payment to * of all costs in excess of the One-Hundred-Thousand Dollars ($100,000.00). Abbott shall make the payments to HDC within thirty (30) days of receipt of invoice from HDC, and HDC shall make the payment to * for any excess costs within thirty (30) days of receipt of notice from Abbott.
II. Phase 1 (expected duration 1.5 months): Develop an assay for the 4-gene prostate cancer test in prostate cancer cells present in urine.
The objective of this phase of the study is to develop the HDC 4-gene expression assay in urine. The assay may be done in up to four separate RT-PCR reactions or in one or more multiplex groupings. The urine sediment containing the tumor cells, obtained after centrifugation, will be extracted to obtain mRNA. Primers and probes for real time, RT-PCR assays will be developed by HDC for the 4 genes of interest and for 5 potential candidates to serve as the reference (housekeeping) genes. While the B2M was the most stable gene in the preliminary studies, a re-evaluation of all five gene candidates will be required. One or more may be selected as the reference gene(s) for the 4-gene assay. In this first phase of the study, prostate cancer cells obtained from tissue culture will be used, and preparations of tissue culture cells will be spiked into urine containing RNAse enzyme inhibitors.
The collection of patient urine, serum and tissue specimens for both Phase 1 and 2 will be initiated and the specimens properly stored beginning immediately upon IRB approval. This will allow specimen collection to be completed in advance of the start of Phase 2.
Exhibit C - 1
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Phase 1 Feasibility Results Completion Standard:
The successful completion of Phase I will be the demonstration of “Feasibility” for the assay, and will be determined by Abbott in its sole discretion. Feasibility will be demonstrated by showing an ability of the assay to identify prostate cancer as present based on an elevated expression of the genes of interest in prostate cells in urine specimens compared to the background expression levels of the normal epithelial cells, using a cut-off that will have *% sensitivity and *% specificity.
III. Phase 2 (expected duration 2 months): Assess the utility of the 4-gene urine test for prostate cancer detection.
The objective of the Phase 2 validation study is to determine if the assay can detect cancer cells in urine from patients with prostate cancer with a high degree of sensitivity. Urine samples obtained from * patients with prostate cancer will be tested. The testing will be done on urine samples obtained pre and post prostatectomy. Greater than or equal to *% sensitivity on pre-op specimens is expected, with all urine positive patients becoming negative when tested one month post-prostatectomy.
A control group of * non-prostate cancer subjects will be tested in a similar fashion on two specimens collected one month apart. One control group of * subjects will be less than 30 years old and have a serum PSA value less than 1.0 ng/mL and the second control group will have serum PSA value greater than 2.5 ng/mL and less than 10ng/mL and will have had one previous negative biopsy. The HDC 4-gene test developed in Phase 1 will be performed on these patients before the second biopsy is performed. The result of the HDC 4-gene test will then be compared to the result of the second biopsy. Control subjects with low PSA are likely to have no prostatic enlargement, while subjects with PSA values greater than 2.5 ng/mL will likely have some degree of prostatic enlargement (BPH). All of the subjects in the control group with a PSA value less than 1ng/mL are expected to have negative results for the urine gene test. Greater than or equal to *% specificity is expected. Serum PSA testing will be performed on all subjects at each time of a urine collection.
For the * cancer subjects, the Gleason Score will be determined and the total tumor volume obtained from the prostatectomy tissue will be measured. The urine HDC 4-gene score for low grade (Gleason Score), low volume subjects as well as those with high grade, high volume cancers will be compared.
In addition, in the * cancer subjects, cancer cells from the formalin fixed tissue slide will be obtained by micro dissection after being carefully identified by the pathologist, and the assay tissue score will be compared with the respective assay urine score.
Exhibit C - 2
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Phase 2 Results Completion Standard:
The successful completion of Phase 2 will be determined by Abbott in its sole discretion, and will be: (i) the demonstration of performance for the assay of sensitivity greater than or equal to *% and specificity greater than or equal to *%, and (ii) demonstration of informative test results for informative urine specimens collected without DRE (success rate) based on sufficient quantity of tumor mRNA for evaluation of greater than or equal to *%. Specificity will be reported against normal and BPH subjects.
IV. Phase 3 and 4 studies (below) will be initiated only upon the review and acceptance of Phase 1 & 2 as meeting the Result Completion Standards.
Costs and Performance Site for Phase 3 and 4:
Abbott at its sole discretion shall select the institution to perform the Phase 3 and 4 testing. Abbott shall be responsible for negotiating and signing the test performance agreement with the institution selected. Abbott shall be responsible for the costs of the selected institution for the performance of Phase 3 and 4.
V. Phase 3 (expected duration 1 month): Determine if DRE performed prior to collection of urine specimens will increase the sensitivity of prostate cancer detection.
The effect of the digital rectal examination to enhance the detection rate will be assessed using urine samples collected from * prostate cancer patients and * non-cancer patients. This data will determine if a random urine collection will give a 4-gene test result that is equivalent to a post-DRE sample.
Phase 3 Results Completion Standard:
Demonstrate a preferred method of urine specimen collection with a success rate (% informative) of greater than or equal to the success rate reported for competitor’s assays (PCA3, *%)
Phase 4 (expected duration 4 Months): Specificity and Assay Optimization Studies
The optimal reaction conditions for the urine assay will be developed, and detection limits and the inter and intra precision for assay will be established.
Exhibit C - 3
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Stability of the mRNA in urine tumor cells under various storage conditions, i.e. * and * will be determined and optimal urine collection and storage conditions will be defined.
With the optimized assay, a preliminary assessment or test specificity of the 4-gene urine test will be accomplished by a) assessing the interference of leukocytes in urine as a result of inflammation or by blood contamination of the urine sample by spiking negative and positive urine samples with leukocytes and b) assessing the tissue specificity of the assay by a survey of urine samples from * patients with cancer types that could interfere with the assay, such as bladder, kidney and others.
The mRNA or c-DNA from the phase 1-4 validation studies will be stored at -70 degrees C for future use in validating any new RT-PCR platform which might be used in an FDA clearance study.
With the optimized assay, detection of tumors with a range of Gleason scores, stages, and various patient characteristics (age, ethnic characteristic) will be evaluated.
Phase 4 Results Completion Standard:
1) The test should demonstrate no cross-reactivity with cancer types that could interfere with the assay, such as bladder, kidney and others.
2) The test should demonstrate reproducible performance under specimen storage/shipping conditions compatible with standard laboratory workflow.
3) The test should demonstrate utility in a range of patient populations and tumor characteristics (grade, stage) with a sensitivity and specificity each greater than or equal to *%.
FDA Submission Study
To be developed and performed by Abbott after successful completion of the Phase 1 through 4 Studies above.
Exhibit C - 4
I was starting on Abbott's contract earlier tonight but since I'm poor as it is with spelling and grammar it takes me forever to gather stuff and present in a way that most here can both read and understand it. What Chazzy and I did the past few days was I would write with my own style and he would correct the grammar making strides not to change my personality within my posts. I enjoy helping for all the right reasons but it is so hard for me to write in a way that is easily understandable. From what I read earlier today referencing Abbott and HDC I was excited. As for Quest I hope they are not sitting on the test but as you can see from what I wrote about them that they paid us $500k for the initial contract signing and then wanted to have us help them with the development of the test and wanted to pay us $375k but pay it quarterly and they did exactly that. So this sincerely concludes that the Trial studies were completed BEFORE HDC hired Mr. Albitar. Also when we see on MARCH 30th or 31st that Quest paid to us the final development monies this should conclude to you that the testing development has also been completed. I believe what is going to happen is that all this stuff I'm talking about that 99 percent of the people are not seeing or bring into their hands at just where we are really standing is going to hit the financial markets with a huge hammer in the future and catch everyone with surprise and surprise in a way that HDC will be also slam dunking many other powerful press releases that are going to catch everyone for the first time which will send our share price screaming up into hog heaven or what ever that place is where all the big dollars are hiding right now. Hey! it will be about time we get recognized so bring it on in time and as you know and myself we have bleed for far too many years so when all this finally breaks with news we will finally smile from ear to ear instead of some of the past embarrassing smiles where tongue ended up pressured against the dam chalk board while lonely tears dripped from time to time down our cheeks.
For now only as I'm not done with my studies! BUT LOOKIE HERE note bold lettering.
ROYALTIES AND FEES
5.1 Royalties. In partial consideration for the license granted hereunder, during the Royalty Term, LICENSEE shall pay to LICENSOR running royalties equal to * percent (*%) of Net Sales by LICENSEE or its Affiliates. Such royalties shall be due and payable on a quarterly basis and shall be submitted by LICENSEE along with the report as specified in Section 6.1 below.
5.2 License Fee. In partial consideration for the license granted hereunder, within thirty (30) business days of execution of this Agreement, LICENSEE shall pay to LICENSOR an amount equal to * United States Dollars (US$*).
5.3 Milestone Fee. In partial consideration for the license granted hereunder, LICENSEE shall pay to LICENSOR an amount equal to * United States Dollars (US$*) within thirty (30) days of the later of publication of the Validation Study (as defined in Exhibit C, attached hereto) showing statistically significant performance improvement over PCA-3 (“Study Publication”) or First Commercial Sale of the first Licensed Use. The following conditions shall apply to this Section 5.3:
5.3.1. If neither the Study Publication nor the First Commercial Sale occurs, or if the FDA issues its clearance or approval of an IVD Kit (“FDA Clearance”) prior to occurrence of the Study Publication or First Commercial Sale, [color=red]no Milestone Fee shall be due or payable][/color].
5.3.2. If, upon FDA Clearance, the Milestone Fee is determined to have been paid after becoming due and payable during a period of time that occurred between three (3) and six (6) months prior to the date of FDA Clearance, * Dollars ($*) of the Milestone Fee shall be reimbursed to LICENSEE within forty five (45) days of the date of such FDA Clearance.
5.3.3. If, upon FDA Clearance, the Milestone Fee had been paid after becoming due and payable during a period less than three (3) months prior to the date of FDA Clearance, the full Milestone Fee shall be reimbursed to LICENSEE within forty five (45) days of the date of such FDA Clearance.
5.4 Study Fees. In partial consideration for the license granted hereunder, LICENSEE shall reimburse LICENSOR for fees and costs related to the Validation Study of the Licensed Technology, estimated to be approximately * United States Dollars (US$*) plus an amount equal to * percent (*%) of LICENSOR’s overhead to complete the Validation Study, such portion anticipated to be approximately * United States Dollars (US$*), which shall be paid within thirty (30) days of IRB approval of the study protocol and before any steps are taken toward initiation of the study. The cost of support vector machine data analysis and support shall be included in the overhead portion, and shall be provided to LICENSEE.
[By Bob, Quote:...the above underlined area does bother me but I may not have a good understanding of it. Is this a part of development fees? I actually think not but wonder about it? Un-Quote]
5.5 Most Favored Terms. The terms and conditions of this Agreement are not, and shall not be, less favorable than the terms and conditions pursuant to which the Licensed Technology is licensed on a non-exclusive basis to any Third Party. If LICENSOR grants any non-exclusive license to any Third Party on more favorable terms and conditions than those contained herein, this Agreement shall automatically be amended effective as of the date of such other license to contain those more favorable terms and conditions.
5.6 Third Party Licenses. If LICENSEE is required to take a license under any Third Party patents (other than the RT-PCR technology) to use the Licensed Technology, then fifty percent (50%) of any Third Party royalty, payment or other liability for such license (a “Third Party Payment”) may be deducted from the royalty payments due LICENSOR (if applicable) for that specific Licensed Use; provided, however, that the royalty percentage due under this Agreement may not be reduced by more than fifty percent (50%) of such royalty percentage.
ARTICLE 6
ROYALTY REPORTS AND ACCOUNTING
6.1 Reports, Exchange Rates. During the term of this Agreement following the First Commercial Sale of a Licensed Use, LICENSEE shall furnish to LICENSOR a quarterly written report showing in reasonably specific detail, (a) the gross sales of each Licensed Use sold by LICENSEE and its Affiliates during the reporting period and the calculation of Net Sales from such gross sales; (b) the royalties payable in United States dollars, if any, which shall have accrued hereunder based upon Net Sales of each Licensed Use; (c) the withholding taxes, if any, required by law to be deducted in respect of such sales; (d) the date of the First Commercial Sales of each Licensed Use in each country during the reporting period; and (e) the exchange rates used in determining the amount of United States dollars. With respect to sales of Licensed Uses invoiced in United States dollars, the gross sales, Net Sales, and royalties payable shall be expressed in United States dollars. With respect to sales of Licensed Uses invoiced in a currency other than United States dollars, the gross sales, Net Sales and royalties payable shall be expressed in the domestic currency of the Person making the sale together with the United States dollar equivalent of the royalty payable, calculated using the average closing buying rate for such currency quoted in the continental terms method of quoting exchange rates (local currency per US$1) by the Wall Street Journal on the last business day of each month in the calendar quarter prior to the date of payment. Reports shall be due on the sixtieth (60th) day following the close of each reporting period. LICENSEE shall keep and require its Affiliates to keep complete and accurate records in sufficient detail to properly reflect all gross sales and Net Sales and to enable the royalties payable hereunder to be determined.
EXHIBIT C
* Study Design
The designated collaborators include Principal Investigator (*), along with Albitar (Quest) , Barnhill (HDC), potentially Madayastha and Guyon, DGX Scientific Directors and MDACC urologists, pathologist, and a statistician (to be named). In order to assure compliance with FDA Regulations and Guidances and CLIA, the Parties agree to the following:
The parties shall establish an Advisory Committee (“The Committee”) comprised of an equal number of representatives from each party to review and guide the conduct of the study regarding regulatory compliance and to help facilitate issues that may arise from time to time regarding the study. The Committee shall meet in person or by telephone at least 4 times per year or on an ad hoc basis as may be necessary. The Parties shall document in writing any discussions that take place in The Committee and shall generate and sign meeting minutes within two weeks after each meeting. In particular, The Committee shall be responsible for managing the contractual relationship, assuring each collaborator’s compliance to FDA and CLIA regulatory requirements within the scope of this agreement, filtering those communications among the collaborators’ whenever necessary to assure that any communications that could place the independence of the validation study at risk are handled in a compliant manner and to assure LICENSEE’s independent development processes, establishing criteria to objectively evaluate the laboratory developed test, and developing and maintaining timelines and deliverables to meet the project objectives.
LICENSOR shall conduct its activities for the study under the direction of Dr. Barnhill, who shall be primarily responsible for the supervision and administration of LICENSOR’s activities under the study, in accordance with all applicable policies of LICENSOR and shall be the primary contact person at LICENSOR regarding the study.
LICENSEE shall conduct its activities under the study under the direction of Dr. Albitar, who shall be primarily responsible for the supervision and administration of LICENSEE’s activities under the study, in accordance with all applicable policies of LICENSEE and shall be the primary contact person at LICENSEE regarding the study.
[By Bob, Quote:...How in the heck could Dr. Barnhill hire Dr. Albitar if we were still in the studies period. No way in heck. Any move as such would have collapsed any chance of success with our technologies, and I believe it would have actually caused our company to go out of business. As I see it, these entire dealings with Quest and Abbott are our last resort to either ‘make or break’ when it comes to our company. If we can't make a successful stride with either one of the most powerful corporations, then who can we be successful with? I'll answer that again, the answer is no one if this fails!un-quote]
MDA shall conduct its activities under the study under the direction of * as Principal Investigator, who shall be primarily responsible for the supervision and administration of MDA’s activities under the study in accordance with all applicable policies of MDA and shall be the primary contact person at MDA regarding the study.
The Parties agree that each will communicate to its personnel the importance of the independence of Licensee in development of the test and its validation. Therefore, the Parties shall actively monitor their activities and agree to promptly bring to the attention of The Committee any concerns or issues that may arise regarding this topic in order to protect the independence of this developmental and validation process. The Committee will then convene as soon as is practicable to discuss the areas or issues of concern and determine the correct process to follow in order to mitigate, correct or advise the Parties regarding them and how best to proceed in respect to the tenets of the applicable regulatory requirements.
The following patient samples will be collected at * for the study:
A. * men being admitted for prostatectomy. Test the patients urine, and blood pre surgery and subsequent follow-up post prostatectomy (at the first post surgical follow up, about 1 month). Urine will be tested for the levels of expression of the relevant gene markers and housekeeping gene, and an aliquot sent out for PCA-3 determination. Blood will also be collected at the same time for testing pre/post PSA levels or other markers. Prior Biopsy results, and Prostatectomy related Biopsy results as well as other clinical and demographic information including follow up data will be provided by *.
B. * men being admitted for Biopsy. We will try to collect ½ study subjects with serum PSA 2.5 to 4.0 and ½ with serum PSA> 4.0 ng/ml. Collect the patient’s urine, and blood prior to Biopsy. Urine will be tested for the levels of expression of the relevant gene markers, and an aliquot sent out for PCA-3 determination. Blood will be collected at the same time for testing for PSA levels or other markers. Biopsy results, and other clinical, demographic and laboratory data as well as follow-up information will be provided by *.
C. Controls consisting of * Men with <1.0 ng/mL PSA. Test the patients Urine, and blood. Urine will be tested for the levels of expression of the relevant gene markers, and an aliquot sent out for PCA-3 determination. Blood will be collected at the same time for PSA levels or other markers. Clinical, demographic, and other laboratory data as well as follow up data if available will be provided by *.
D. Pre/Post DRE: * men who are candidates for biopsy and agreed to pre/ post DRE urine and blood sampling prior to biopsy. Test the patients pre and post DRE Urine, and blood pre biopsy. Urine Pre and post DRE will be tested for the levels of expression of the relevant gene markers, and an aliquot sent out for PCA-3 determination. Blood will also be collected at the same time for testing PSA levels or other markers. Biopsy results as well as other clinical and demographic information including follow up data will be provided by *.
E. Preclinical Studies: Urine sediments from patients and tissue cultures will be used for preliminary assay development and for selection of the best mRNA preservative.
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I believe our corporation intends to wait this out to a time of maximum impact that it can have on the industry. My guessing along the way is like a broken record as every turn masks a new answer NOPE! a new question! All in all I know we have completed the trial studies. and as is stated in the milestone area 5.3 just maybe we are laying low for many reasons, to finally show in the end our "FIRST COMMERCIAL SALE" announcement which would mean NO milestone fee or even a discussion about it". Barnhill, bring it on as we are weary of all the work we shareholders have been doing these past years. Yes we are tired!
So! In February 2009 we inked a deal with Quest and Abbott. Let me stop right here for a jiffy and look at that again: So this little company of ours (HDVY) had actually inked both super powers, Quest Diagnostics & Abbott Molecular in which one is the world’s largest diagnostics company and the other the largest Pharmaceutical corporation in the world. The fact also remains that we were able to ink these contracts on the same day!! I must sincerely add that I‘m in agreement with others that also feel that Abbott and Quest are working far closer together to bring about this test than I had previously thought. I mean with both Quest and Abbott signing on the very same day, hello.
Quest Diagnostics agreed to pay HDVY a sum of $500,000.00 dollars for the initial contract agreement and to pay $375,000.00 dollars to HDVY for their help in development costs. Our first 10-Q filing indicated that the $500,000.00 initial contract signing payment and also $41,666.000 in development costs was paid in our 1st 10-Q filing. Our 2nd 10-Q filing shows that Quest paid us $124,998.00 dollars and our 3rd 10-Q filing we were paid another $124,998.00 dollars with a balance of $83,338.00 which has actually been paid but we will need to see this in our next filing, which will be out on March 30th or 31st of 2011.
This combined with the previous information which been posted here in our message thread not onlydetermines that the trial studies have been completed but also the development of our product. There is no way Quest would pay us all this money if first the trial studies did not work and then if we could not help them develop/complete the product. So folks! I see happy days ahead of us when viewing facts from our SEC filings. As Chazzy has been saying, our SEC filings have been talking to us but we haven’t been listening.
LuAA21004 is an antidepressant and anxiolytic currently under development by Lundbeck and Takeda for the treatment of major depressive disorder and generalized anxiety disorder. I thought I could find something in patents involving LUAA21004 and SVM or FGM technologies but no, no relation as I can see?
King, it is like this! "Liberty Analytics Co", will do an initiate coverage on many different corporations in many different areas to try and pull your interest in going to their website and subscribe to their service, meaning you pay them money if your wish to be in the know, it is basically that simple!...well that is how me and Bob seez it.
I feel clueless most of the time!.eom
Chazzy, I see it that way to, I may as well have my shares listed in case any 144 requirements, especially if I might need to sell into a run or perhaps just to buy the warrants?
Ou71764, I want you to read the following from Vermillion which goes back to an alliance agreement between Vermillion and Quest as follows.
On July 22, 2005, Vermillion entered into a strategic alliance agreement with Quest pursuant to which the parties have agreed to develop and commercialize up to three diagnostic tests. The term of the agreement was set to end on the earlier of (i) the three-year anniversary of the agreement, which was July 22, 2008, and (ii) the date on which Quest commercializes the three diagnostic tests. On July 21, 2008, Vermillion and Quest amended the strategic alliance agreement to extend the term of the agreement to end on the earlier of (i) September 1, 2008 and (ii) the date on which Quest commercializes the three diagnostic tests. Subsequently on October 24, 2008, Vermillion and Quest amended the strategic alliance agreement to extend the term of the agreement to end on the earlier of (i) September 1, 2009 and (ii) the date on which Quest makes its third development election. To date, Quest has selected only two diagnostic tests, which are peripheral artery disease (“PAD”) blood test (“VASCLIR™”) and ovarian tumor triage test (“OVA1™”), to commercialize. Vermillion’s major initiatives are currently aimed at commercializing these diagnostic tests, both within the context of its strategic alliance agreement with Quest as well as markets in which Quest does not participate, to the extent permitted under the strategic alliance agreement.
Ou71764 now I want you to look at the following which I pulled from a different area within Vermillions filings. Now remember we were looking for one type of filings from Quest and a 510K filing from Abbott. Now I'm no doubt NOT the smartest man on the block which is as said but look deeply here and look.............Vermillion NOT Quest or NOT Abbott filed their 510K application with the FDA referencing the OVA1 test in June of 2008 and the FDA cleared the test on 9/11/2009.
My questions are firstly if it takes basically 15 months to get FDA clearance after the 510K is filed then how long will it take us to get in a position so we are able to do our 510K filing? Now really listen closely? we all know that we have an easier route to take than doing any 510K application filing yet why in the World (even with Quest backing Vermillion with money guarantees) did they not go the easier route or was it not available in 2008. Next!! if there is any political BS going on to slow up our debut/test will Quest now FORCE us to follow suite and push us towards the slower filing which of course we all know is a 510K application.
I sincerely do hope a few here with the market/business related knowledge can weed through my post and see just how deadly the plate may or may not be. I sure wish that LTDcoverage would post about this concern but if it is too hard to understand my writings then I would no doubt need to explain this over the phone but I must tell you I have far more concerns about this post here and translated thoughts to this than of course Mr. Quirk's warrants.
Don, yes they did reverse their stock, it was a 1:10 on 2/15/08. eom
I do like the idea that our prostate test having far more potential and we need something as such in order to be able to fall back on real income. Actually we are a threat to the PSA testing community? Has anyone thought about this area and could Quest be forced to sit on the test and delay things?