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The part I like the best is:
"During the conference, the company will reaffirm its adjusted 2011 outlook before future special items."
Never ceases to amaze me..
WARRANTS EXPIRE..
Oh I didn't know you went to the meeting. You should have said something.
Oh I didn't know you went to the meeting. You should have said something.
Good try. It's just an accumulative analysis running general searches on the web for cancer studies. It only mentioned HDC as a diagnostic company in a broad list. It mentions GHDX's breast cancer test which is already out as a study. It also referred to ASCO in 2005 so I doubt it was written after 2006. Also the name of the file implies it was put together in Jan'06.
The only interesting part implied an HDC affiliation with Standford.
Appreciate the vigilance!
Dr. Wayne averages 12 Whipple procedures a month. They signed the agreement in Feb. I would think two hundred would be a nice round number needed for analysis but who knows.
"We expect to choose our partner.."
As in more than one party interested? Would be nice if they signed something by December but March is more than reasonable.
Well here's the beauty of the melanoma app. Despite the fact that there is precedence of it being able to diagnose melanoma's with up to a 98% accuracy, it won't have to. It's not going to officially "diagnose" the melanoma. It's purely a "risk assessment". The algorithm will have a great idea of whether or not it is cancerous but it will simply refer consumers to a dermatologist. Even they have been documented as only being 80% accurate in diagnosing a melanoma accurately. The gold standard is the biopsy which will be performed for all "high risk" patients. Hence, the app will never need FDA approval.
The real benefit of the app comes through increasing self-awareness in the population. Consumers will be able to be more proactive about skin monitoring without spending the time or money to see a dermatologist for being too "nervous". There is a broad range between medium and high risk nevi that the app can easily separate. These are the ones that dermatologists won't biopsy but they will recommend to monitor over time. I believe some of the added functions will be a database so that consumers will be able to catalog and decreasing costs to the consumer through minimizing the data transfer. Since there is no guarantee that everyone has an unlimited data plan with their phone company, Dr. Zhang came up with a brilliant way to narrow the amount of data sent to the company.
Don't get me wrong, I am not happy with the delay. Releasing the app for after US summer season would have been perfect timing. But in the end, I would want them to pack the app with all the best features as possible rather than to constantly upgrade people over time. The concept is innovative: Spatial recognition meets the Open Table style of dermatologist referral meets the cell phone. The overhead is incredibly low and the benefit to consumers is strong.
Good point. I was thinking lately that they might try to release the melanoma app in time for Australia's summer. Barnhill did go out of his way to mention general interest coming from there and their population stats regarding melanoma incidences. I do agree that eligibility for the milestone payment isn't big in the short term, but if they release some statistics on the preliminary results or the actual validation study, we are sitting pretty.
In the meantime, we have the 10-Q coming up next week as well the FDA committee decision for MELA. There was a fair amount of enthusiasm regarding pursuing patent infringement if they do receive approval.
I definitely agree with you. I can't see the quick sell either as this will be retirement money for most of the board members. With approx 22 million shares, I doubt Barnhill would sell the bulk of his life's work without being fairly comfortable for the rest of his life.
I can't say I've been here as long as many others here but I am grateful to witness the shift in their revenue generating policies at a time when I got in. Going from small license grants to demanding actual percentages of other companies profits is ballsy but not unrealistic considering the amounts that the bigger companies stand to make. Though a 10 multiplier would be nice, I can't see them settling on that alone. The iPhone app alone could generate 10-20 million dollars a year easily without including the revenue from biopsies. That could equate to a share price of $1.50 by itself.
I have every confidence that everyone from Dr. Barnhill to Dr. Guyon to the new assistant will get as much as they can get!
So true. In theory, these guys are sitting on a gold mine. Contemporary research and methodology are running with SVM's with both arms as it is a tool to make a niche for themselves in the science community. The hard part has been verifying that valid applications of SVM's are accurate and reproducible; But hundreds of published studies have been doing that for the last decade.
I think many people have underestimated how long the process from theory to commercial use takes because of licensing pr's but HDC is nearing the hilltop with the ocean soon in sight. The patent production is solid and the pipeline is impressive in its innovative targets.
Monetization of SVM's is by no means an easy process. It's like trying to sell calculus to a bunch of algebra users. And a better mousetrap is only good if you have mouse problems. But with the growing use of SVM's and its broad applicability, I don't foresee many problems for HDC. A good faith indicator of HDC's revenue potential will be this year's royalty payment from Bruker in the next 10-K. It won't be a lot but it is representative of a growing value of HDC's patents.
$9.41 Q1 2014!
Eh? They patent everything they work on from the process to the results. I hope this can clear things up.
U.S. 7,117,188 Method of Identifying Patterns in Biological Systems and Uses Thereof
U.S. 12/025,724 Biomarkers Upregulated in Prostate Cancer
U.S. 12/242,264 Biomarkers Overexpressed in Prostate Cancer
U.S. 12/327,823 Methods for Screening, Predicting and Monitoring Prostate Cancer
U.S. 12/349,437 Methods for Screening, Predicting and Monitoring Prostate Cancer
Australia 2002253879 Methods of Identifying Patterns in Biological Systems and Uses Thereof
Canada 2,435,254 Method of Identifying Patterns in Biological Systems and Uses Thereof
Europe 1459235 Method of Identifying Patterns in Biological Systems and Uses Thereof
Japan 2002-560076 Method of Identifying Patterns in Biological Systems and Uses Thereof
Europe 1828917 Biomarkers for Screening, Predicting, and Monitoring Prostate Disease
This one was from the same board.
http://www.healingwell.com/community/default.aspx?f=35&m=1890527
Posted 9/3/2010 9:26 AM (GMT -6)
I've taken the same test at the Colorado University Med Ctr for the last 18 months.
Post Edited (Ziggy9) : 9/3/2010 8:50:09 AM (GMT-6)
That puts the start of testing as early as a month after the deal was signed with Abbott in 2009.
Thanks for the nod. TBH I'd be pretty disappointed as well.
Completely understandable considering the time periods. I admit I had a very different timeline when I first read the prostate tissue test study. Until I reread certain sections, it became pretty clear how long it would really take. But now that we're on the cusp of a few validity tests results, growing popularity of SVM usage by academics and the transition to corporate use, I've been feeling a lot more at ease.
Nope. You've posted nothing that was near factual except your absolute obsession with the outstanding shares. It remains questionable as to why you continue to post here rather than just selling off and surreptitiously going away. Other than obvious ulterior motives, "of course".
Actually that was a sarcastic rhetorical question. I really don't care.
Seriously? Really?
No one said it would be now or immediate. Get a grip. All he said was that having an authorization in place makes complete sense and that he didn't think doing a reverse split to uplist to the Nasdaq would be a good idea.
Have you been successful in emailing the transfer agent?
I certainly don't disagree. I admit I wasn't dazzled when Dr. Barnhill started to rehash their position on the urine test. But as the presentation went on, one thing I was impressed by was their methods to patent and protect every step of methodology and research. And considering the growing number of published journal articles using SVM in such a wide array of research, I felt much better knowing the value of the patents will on grow as well.
I'm not entirely sure he would wait a long time before pouncing on a company. In fact, he seemed very enthusiastic about other companies nearing production and distribution. Considering the millions companies have spent into developing a product, I imagine it's in their best in to settle any infringement suits as soon as possible. HDC is quite aware of companies already nearing FDA approval using their technology and receive more and more notices from investors about potential infringement abuses. Though they might issue the occasional cease and desist order, the board seems most vigilant about securing due revenue.
That really is pathetic. The share structure was clearly stated in the proxy vote portion of the meeting by Tom Gallagher. Oh I forgot.. YOU WEREN'T THERE!
If you were, you might have heard the discussion about the share buyback authorization. I suppose that still would not appease your conspiracy theory line of thinking.
It's one of those consolidation periods where anyone attending the meeting and talking to the board is reassured. If there is a further drop in price, I'm certainly gonna take advantage of those who are selling. In the meantime, it is still a waiting game though the uncertainty of "If" is gone.
-Validation of the urine test by Abbott is coming closer (The pre-Christmas timeline is more than reasonable.)
-Quest's own R&D of the urine test will finish when they are thoroughly done, including quality control of the test production. No NDA could have suppressed the sheer optimism and pride in their 4-gene test.
-iPhone app still undergoing negotiations with national lab groups. I would imagine they (perhaps Quest) are playing hardball because of the large infrastructure that's already needed to be in place to maximize revenue potential from the referral base. This would have limited the number of options HDC would approach from the onset.
-Other validation studies probably won't be ready for announcement until next year.
-In the meantime, SVM continues to grow in popularity among academics with more and more research papers released into publication. Companies continue to bolster their own patents on the shoulders of the HDC "fortress". And as those companies who are foolishly close to product approval without talking to HDC are setting themselves up for steeper penalties.
Just the patent portfolio alone couldn't get me to sell any shares. And I imagine anyone who only listened to the Q&A (even if they did not get a chance to talk to some of the officers of the particulars) would also have trouble selling any shares.
Here is one more take on the meeting:
Overall, it was definitely worth the trip. The board members and scientific members were extremely gracious and welcoming. Anything not covered by an NDA was openly explained in a fair amount of detail. Getting a chance to meet a few of the other investors was a good treat and Smith turned out to be the belle of the ball. The general presentation was both a nice review of the company and its pipeline but it also gave a few tidbits not found in any research paper or SEC filing. By far, the best information came from individual conversations before and after the meeting.
One such example is getting Dr. Barnhill's take on the Vermillion settlement which I know is a touchy subject with some posters. Many people have complained that the negotiations were a farce in that HDC came away with such a "small" amount of cash afterwhich VRML shot up to $33. His immediate, frank reply was to say that 1) they didn't think the test would make a huge impact simply because of the population target, 2) they were VERY aware that the VRML was headed towards bankruptcy 3) receiving any type of payment, however "small", would be the first in legally validating the technology. The validation point made complete sense and in retrospect, VRML just passed a quarter where a little over 300 tests were done to date. And they are paying for all their bills through company shares as evidenced by their impressive decline from $32 to $5 and change.
There were plenty more tidbits of information through the Q&A and smaller conversations. Smith is covering most of it on Yahoo and her account is fairly thorough. I'll admit I went to the meeting supportive of the company yet retaining a fair amount of skepticism and doubt. I left far more knowledgeable and reassured that my investment is well placed. Certain products of the pipeline looked to possibly have a far greater impact than I had imagined. The amount and quality of work being pursued by Dr. Zhang and Madyastha is impressive in its continuing innovations. The followthru by their patent lawyer, Ms. Musik, is impressive in itself. Every step of every area of innovation and research is being patented. Their IP portfolio really IS a fortress. The best part is, many others are consistently citing HDC's patents when submitting their own. A funny example given involved a new submission for an SVM patent. The submitter had placed 3 references in the original submission. The patent officer had followed through and added on 13 more, all referencing HDC!
In summary, I really feel we have a strong group of individuals working very hard to bring value to a new company. Our investment is well placed and the current share price is undervalued considering the high reward/ low risk. One last tidbit that I'll finish with was a comment from another attendee on a side conversation he had with Dr. Barnhill. When asked where he thought the company would be in five years, Dr. Barnhill simply said, "Acquired."
NO!
You are seriously off your rocker on this. Quit being so obsessed with the O/S. Just because you called the company on the Friday before their meeting to ask the SAME question AGAIN, doesn't mean that there is a conspiracy because they didn't get back to you. By the way, who else does that? Who calls about a penny stock every week and ask about their number of outstanding shares? The company doesn't even have profits to calculate any type of meaningful fundamental analysis. If you want to find what the O/S is, JUST CALL Gallagher. Out of all the things to research, why in the world would you focus solely on the share structure? Go read a SVM paper and seek help.
LOL! You broke it!
I know, right? Thanks for the insight on the FDA side of things, Zeno!
The irony here is that some people try to paint HDC as Zeno's Arrow; An object defying motion and never going anywhere. Yet the poster ZenosArrow shows how HDC will move from here.
He left the board cause he IS:
R.
Scott
TOBIN!
Dun Dun DAAAAAAAAA
Thanks for checking. I've been thinking the same thing though I too didn't want to get excited for the same reasons.
I was originally content to wait until December for the updates but I am very hopeful that they do it within the next two weeks. My Christmas list is still the same though:
1) validation study results of the urine test:
-"The Company expects to be eligible for the milestone payment by year-end."
That indicates the end of P2 and the completion of the urine study. Based on the results, Abbott would continue with P3 and pick up the costs for the test kits. Quest and Abbott would also continue with the LDT for the urine test as there would be official confirmation that the urine test works. (They would not have tried to market the LDT based on tissue test results from the prior, published study. Besides detecting cancerous cells, if the 4-gene test can distinguish BPH as well as they think, the urine test may only be the beginning:
-"This same set of genes also separated BPH from normal tissue patterns, indicating that BPH is a disease with molecular characteristics of its own. This discovery could be used to develop a new non-invasive diagnostic test for BPH, which does not currently exist, as well as a completely new type of therapy for patients with this disease. This patent-protected gene set was developed in association with an international pharmaceutical company to be used as a surrogate biomarker for their clinical trial evaluating a new BPH drug."
2)The melanoma app:
On the change of tone from quarterly reports, it looks like they have gone on a slight tangent and is developing something just for dermatologists:
-"A beta version of the app for use in clinical settings has been completed and the Company is working on deployments with dermatologists for field testing."
Similar to MELA, if HDC has developed a strong algorithm, it only makes sense to continue and develop a non-invasive tool for dermatologists to diagnose cancerous from non-cancerous cells. Interestingly, MELA has developed a hand-held device for use in the clinic but their might be question as to whether they will receive approval from the FDA because the algorithm may not sufficiently achieve statistical significance.
That's not to say that they stopped working on the risk assessment tool for the general public.
-"A more advanced version of the app with features and a user interface optimized for consumer use is currently in development."
3) Other validity tests:
-"The Company hopes to complete validation of its test for leukemia in 2010."
Its completion would not only lead to another LDT, but also the confirmation that the flow cytometry interpretation product is effective and up for partnership/ sales. I also believe that other huge tests would be the pancreatic and breast cancer tests. I don't expect validation to be completed by next year but a early detection tests will save many lives.
With the increasingly successful use of SVM's in research studies all over the world, it cannot be denied that the method is useless. Though relatively new in its own development, SVM is making its impact felt in the science community. Even if HDC is only able to monetize a small fraction of their intellectual property, we'll all be financially secure. I don't necessarily agree with all of the company's policies or actions, but I believe they are in the right direction on the road to revenue. I only hope we will ALL look back at these times and just be thankful we saw HDC before its success and say "We were there."
Gee tell us what you really think Boba. =D
From what I understand he's a "hand-shaker" in Savannah. He gets around through his venture capital company, charity organization, and served on the board of a hospital and museum. He's one of the early investors HDC. It could be that this is just a reward for his support and friendship. But also keeping the duties of individual board members in mind, he's one of the few non-scientific members they've added in a while. It could imply he'll have in-house duties regarding personnel and quality control. I guess we'll find out.
Heheh. Where did that come from? I believe you're thinking of GenProbe.
LOL. I bet whoever sold that chunk going into closing didn't expect the MM to just pick it all up.
Well thank you for those nice words too.
Good luck to us all! We're gonna do great here. (IMHO)
Ha! you gotta like that! I thought they were gonna present a week after the shareholder meeting. Now they present with Quest the day before the meeting. I am so psyched. It's like going into the river card with the full house nuts. I just hope we don't get one-out'd with a 4-of-a-kind.
Interesting find, Karl. I haven't read this one before. Quest seems to say that they were able to differentiate PCa with BPH but only with a specificity between 91% and 100% depending on exclusion criteria. And yes, Albitar was a co-author on the study which is nice considering an additional marker would be nice to round things out. But there signal gene marker isn't part of the original 4 gene assay and thus not patented by HDC. Also the test is based on tissue samples so the translation to urine is another big step.
Now if you are right, and Quest is doing their own in-house study, it would explain the long delay as they are just trying to either confirm HDC's stats or convert their own finds for use in a urine test. Their sample sizes are really small and it would require for them to repeat it again, except with urine samples, and with at least 5-10x more subjects.
Personally I think if HDC is able to reproduce similar results to their urine test, which they seem so confident they are, they really will be able to replace the PSA as the first test to use for diagnosis and the PSA would be a secondary backup. I guess we'll see when the validity study comes out in the coming weeks.
Um ok..
Tech and Karl suggest that Quest should release news of the test first because their LDT does not require FDA approval.
I say that Quest won't do anything until the urine test is validated by another study. (The first study with it's great results was a tissue test, not a urine test.) Therefore, I think Abbott will talk first because:
HDC said "The Company expects to be eligible for the milestone payment by year-end." That is contingent on completetion of Phase I and Phase II results conducted by HDC. That equals the first release of the validation study using urine.
If those test results are strong, Quest will run with the urine test while Abbott takes over and continues with P3 and 4.
That's about as short as I can make it.
Wait just because they don't need FDA approval doesn't mean that Quest doesn't want a few validation studies before they spend millions to do so. The first and only validation study was a tissue based test. It's accuracy has not been verified using urine. The study only implies in the last sentence of the paper that the same bio-markers might be used in a urine test considering it only took a small amount of cells for a verdict. That's what makes their announcement of the receipt of the milestone payment so key: They will have completed the study and release the results.
"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."
In this way, Quest gets some reassurance that they will spend their money wisely. Unlike other irresponsible companies who release their tests to K-Mart and "Tarjay", they are demonstrating standards at least equal to that of the FDA. I always wondered why everyone was bitching bout Quest when in fact HDC was the one behind the wheel and rubbernecking on the urine test results.
I can't wait to read the results when it will be released "before year's end." Once it's out, Quest really has no excuse to slam on the accelerator and gun it as fast as possible past Abbott.
Heh I noticed that too. I almost posted but realistically Abbott has more to say on the matter before Quest does; And they don't release til a week after the meeting. Also Tobin's last day of work occurs the Friday before to bring on a new era of running Gallagher into the ground.
I pretty much agree. It seems fairly reasonable that we'll have all the PR's prior to the shareholder meeting and the meeting itself will just be a formal review. Now whether we have the PR the morning of, or the weeks before, it would be immaterial. There is plenty of info that needs to be disseminated.
We have a pretty solid consolidation in share price. Breaking .22 or even holding .195 two weeks from now would be a really good sign.
From what I understand is, those phantom shares are exercisable at the current stock price for any of those new warrants. So let's say some douche pushes the stock price to .15. He will be allowed to apply his .30 warrants for example and covert 2 million of those to the current stock price, ie. .15 cents. It's a stupid clause to give him a second change to pick up shares below the warrant price.
As for who exercised those warrants, it is not necessarily Quirk. Read this again.
http://www.sec.gov/Archives/edgar/data/1141788/000118811210001292/t68034a_posam.htm
A few others had the waarrants at the same strike price.
Is it possible you meant the Avia Hotel on Barnard St?
Thanks in advance for the clarification.