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reads,
<<< Tim Clemenensen said that the delisting condition on the loan foreclosure had been "expunged." >>>
That is just a comment from a poster. You care ? Not factual. Show evidence for it.
<<< when the CEO's salary alone is now running more than the total sales of the company. >>>
Who cares ? Hundreds of biotech companies pay salaries to a CEO without being profitable. Name biotech companies which are not profitable and have CEOs working without salary.
<<< and lets face it, this company needs ALL the positive input ...>>>
The company needs nothing. Why ? The company executes the business plan and that's it.
Yes it is a buying opportunity
<<< This is a buying oppt (IMO). >>>
I also don't understand why people complain about low number of sales. The company even announced recently that there will be no significant sales throughout the whole year 2006. The most recent projection of Calypte does say so.
There are hundreds of listed biotechs which burn money (and are well respected). Being not profitable is not bad per se but could be part of a development process. Serious people who are invested in this company do not expect sales this summer but in the future. The only relevant issue to discuss is whether there will be sales in the future or not.
Cal
bloodhound99, you're reads from Yahoo board, right ?
I guess the moderator will remove my post soon from this board according to the rules of ihub (which is ok) but I think it is nonetheless worth posting it.
Why have you stopped posting on Yahoo ? Did it get boring over there ?
How pathetic !
Cal
bloodhound99,
the idea that Marr wants to take over Calypte soon is pure speculation (frequently shopped on other message boards) but nobody has ever provided any serious evidence why they should/would do so.
What would it help if they fully owned Calypte ?
Cal
Thanks to all those who posted recently !
Just wanna let you know that this board is a very good one. I really appreciated the messages during the last couple of days. Thanks to coin and sower for running it. And it seems that there are much more people who read this board than people posting here.
For the default clause, just another thought:
Why should Marr take the losses of Calypte and put it onto their own balance sheet? They have control anyway?
Good luck
Cal
Thanks coin!
coinstarz,
I asked myself why they voluntarily made this delisting move.
Does this make any difference or does this have any advantage ?
My thought was it is possibly about timing, it gets them quicker again on some other exchange ?!
----------------
"... to withdraw its common stock from listing on the Amex effective as soon as practicable ..." ???
Following a required notice period, Calypte's common stock will no longer be listed on the Amex. At that time, the Company expects that its common stock will trade on the NASD Over the Counter Bulletin Board. The Company is in the process of obtaining a new trading symbol.
----------------
They want to be listed at least somewhere when sFDA approval occurs. The worst thing would be big news when listed nowhere at this specific moment.
Does somebody else know this ?
Thanks
Cal
sower, I can not really see too why the AMEX delisting will make a huge difference. Well I admit I'm not very familiar with the various exchanges but my believe is that at the end of the day the fundamental story and the commercial success decides.
It also wouldn't make sense if Roger Gale moved to a dead company from London to Portland just a few months ago. He has sure also considered delisting when he signed the contract.
Anyway, I hope that the company can give us something positive with the next CC and offers clear honest info about the financial situation after this financing event and the delisting. We have to be patient again.
The response from the sFDA should be next now which finally could mean something really positive.
Good luck
Cal
sower, obviously you are right.
Some people don't like to own a delisted stock.
The question is now for me if delisting changes the fundamental picture significantly.
Will it become now even more difficult to raise money ?
How will Marr react to it ?
We need news from China soon, that's for sure.
Cal
I'm surprised
that the stock price is strongly affected by this delisting. I must admit that I haven't expected it. It will be interesting to see how we go on from here the next couple of days.
<<< where is everyone? >>>
rcgold44,
I guess everybody is right there and waiting. We will see what happens next week with AMEX and news with sFDA are also pending.
When everything is said we can just wait.
Good luck
Cal
flashlight,
I believe that the company will be successful in the future and I would also not be surprised if Calypte stays listed at AMEX at least for another limited extension. It is not unlikely imo.
But I'm also aware that this is a high risk investment. It is a penny stock and there are good reasons why this is so. Nevertheless I'm invested here because I'm interested in high growth potential, something I can not find in a low risk stock.
So Calypte could be removed from AMEX beginning next week. It is possible. Nobody knows at the moment. But even in this case I don't think at all that this will seal the fate of the company. Everything depends on the companies ability to create some revenues in the medium term. We have seen recently that the company is indeed getting some sales. The product seems to find a demand, it is competitive and the price is acceptable. THe management with the new business plan has proved imo that it can get it done. Financially the company is low on cash which is the most important risk but this is how penny stocks look like (either before they falter or break through the wall).
I'm not posting here and elsewhere in order to lure others into this stock or influence the pps according to my own personal interest.
Good luck
Cal
two more months
<<< We will have to wait two more months for the Chinese FDA news >>>
Hey coin,
you meant until final decision but not until the first notice of sFDA, don't you ? Or do have more info ?
Thanks
Cal
I forget to mention approvals in Kenya and South Africa, haven't I ?
sower,
I think Calypte has collected at least some good arguments during the last couple of months for the AMEX issue (financing, firm deal and first significant sales for oral test, the USAID waiver list for the blood test). Arguments they have not had in February and March when they met with AMEX and the deadline for listing/delisting was set. Hopefully sFDA will respond also with something positive until month's end.
The question will be if AMEX looks strictly on the self-imposed rules or if they see this rather as a political or business decision. I think they like to keep as many companies as possible as long as those companies have some promise and do not ruin the reputation of AMEX more than necessary. I don't think that Calypte can be filed into the latter category.
Anyway, AMEX listing does not matter really (to me), it is important that the company is progressing and executing successfully the business plan. Since Roger is at the helm the company did very well in collecting the necessary milestones. Every piece takes its time but there is constant solid progress now. This is about getting the pieces together, one after the other.
Cal
News: Important for marketing blood rapid test
<<< This progress will hold hope of additional sales this year; however, the oral test has greater potential for sales. >>>
sower,
I believe too that this could lead to some sales because it clears one of the most important obstacles for the company in terms of getting sales from the rapid blood test in African countries. They need to have the test on this list otherwise most of the funded deals can not occur.
Btw as I remember there have been several reports or comments that the blood test performs better than most other established blood tests available.
It is good to have this progress.
Now I'm thrilled to see what the sFDA will reply soon and how the AMEX issue turns out. I have not given up hope that Calypte stays at the AMEX.
Cal
NEWS !!! Blood test approved USAID waiver list
LAKE OSWEGO, Ore., July 20 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV; the "Company"), medical diagnostic tests manufacturer for the professional point of care (PRO) and over the counter (OTC) segments of the market primarily for the detection of antibodies to the human immunodeficiency virus (HIV) announced today that its Aware(TM) BSP HIV-1/2 Rapid test is now approved for addition to the USAID waiver list, that is, the Acquisition & Assistance Policy Directive (AAPD 05-01) which permits this blood test to be used in USAID funded projects.
USAID provides assistance in four regions of the world: Sub-Saharan Africa; Asia and the Near East; Latin America and the Caribbean and Europe and Eurasia and has funded almost $6 billion since the inception of its HIV/AIDS program in 1986, more than any other public or private organization. USAID currently has HIV/AIDS programs in nearly 100 countries worldwide. USAID has delegated the task of evaluating HIV tests and deciding if data generated by that evaluation is sufficient to support that test being added to the waiver list to the Centers for Disease Control and Prevention ("CDC"). The CDC GAP Laboratory Support Team completed the interim validation of the Aware(TM) BSP HIV-1/2 Rapid test. The test met the requirements specific for USAID Waiver and CDC recommended it for inclusion in the waiver list. USAID has confirmed that the kit is so approved.
Roger I. Gale, Chairman and Chief Executive Officer of Calypte noted, "Only those assays meeting stringent performance criteria are placed on the USAID waiver list. This approval for the waiver list means that our product can now be used by USAID, the largest potential customer in the world. It is an additional validation of our rapid products as we expand our reach worldwide. As we continue to focus on humanitarian efforts, such as the announced roll out of MineSeeker's African HIV/AIDS testing initiative, being on the USAID waiver list is expected to enhance our credibility and facilitate our involvement in further humanitarian programs."
Mr. Gale continued, "At the same time, we have authorized an evaluation of our Aware(TM) OMT HIV-1/2 Rapid test for the USAID waiver list. Specimens are being collected over the summer and I estimate that the process can be completed towards the end of the year. The Aware(TM) OMT HIV-1/2 Rapid test is our single use, point-of-care aid in the clinical diagnosis of HIV infection that uses human oral fluid specimens to give results in less than 20 minutes. This test may also be used as a component of a multi-test rapid algorithm in conjunction with other approved HIV antibody assays."
poorme,
the stock price is probably affected by the open AMEX issue. There will be soon a decision whether the company will stay listed at AMEX or not (end of month).
I personally believe that this AMEX issue is quite insignificant when compared to the ongoing commercialization process. I don't know how the markets feels about AMEX listing, I myself at least do not base my investment decision on this listing decision, I believe that the company will be commercially successful soon which is the only important issue to me.
Also I don't want to risk waiting at the sidelines when approval in China happens. The latter is very well possible now every day.
Good luck
Cal
"Glad to see Yahoo HIV board down anyway"
I agree because I always tend to get into these "discussions" on the Yahoo board when absurd negative comments are posted there.
I think all those you understand the fundamentals/potential of the company as well as the recent progress won't miss this board.
We are getting closer to success in China with every day passing by.
And from this SA contract we have finally evidence that this is not about potential but real business. There is a market for the oral test of Calypte even if the price might be a bit higher than for a blood test.
Cal
imo whole deal of 5 million tests likely
<<< Mr. Mike Kendrick, founder of MineSeeker, stated, "The intended first order of 1 million tests is part of a larger MineSeeker initiative to deliver 5 million HIV oral fluid rapid tests to Africa. The purchase of the initial 1 million Aware(TM) HIV-1/2 oral swab rapid tests will be donated to NGOs for distribution in the field or sold, at cost." >>>
Who can deliver oral tests in Africa ? Only Calypte and Orasure but Calypte has a much better price and why changing the company when the first 1 million delivery is ok ?
I think (my speculation) that Calypte will get the whole deal of 5 million tests in the future.
Cal
There is a new article in SCIENCE which is one of the most significant scientific magazines around.
It is about a recommendation of mandatory testing of the HIV high risk groups in China.
No free access to a copy
but I think this illustrates the importance of the problem and the market potential of the oral test in China)
Science 9 June 2006:
Vol. 312. no. 5779, pp. 1475 - 1476
DOI: 10.1126/science.1120682
Policy Forum
PUBLIC HEALTH:
HIV Testing in China
Zunyou Wu,1,2 Xinhua Sun,3 Sheena G. Sullivan,1,4 Roger Detels2*
Active testing for HIV among high-risk groups in China, although controversial, is in the best interests of public health.
1National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 100050, PR China. 2School of Public Health, University of California at Los Angeles, Los Angeles, CA 90095, USA. 3Division of AIDS, Department of Disease Prevention and Control, Ministry of Health, Beijing, 100044, PR China. 4Centre for Human Genetics, Edith Cowan University, Joondalup, Perth, WA 6207, Australia.
*Author for correspondence. E-mail: detels@ucla.edu
Agree Que, pps holds up nicely
seems that those people who are curently holding shares know why they still do so.
In fact, the 1stQ results are not brilliant and there is nothing sensational but who expected anything different this time.
We are awaiting more important things to become clear soon (financing, approval process in China). This will be the time to draw rather general conclusions about our future prospects. Let's hope the company gets a fair money deal soon. It won't be easy though this could be a perfect turnaround opportunity now.
I'm looking forward to get more info about why Roger Gale took the helm. It makes sense because a company having a monthly burn rate of 500K cannot spend lots of cash for a CEO but it is surprising nonetheless considering his background. He takes quite a risk personally.
I also feel threse days that a strategic move, buyout or merger could be a wild-card for the investor.
Cal
Hi que, many thanks, very helpful info:
Most remarkable to me is:
"The CDC plans to recommend that, pending revision of state and local laws requiring written informed consent -- a process that could take years -- HIV testing be offered to everyone ages 13 to 64. The test would be bundled with routine screening tests such as those for cholesterol and blood glucose as a normal part of care in doctors' offices, clinics, hospitals and emergency rooms."
So how is OTC sales and signing "informed-consent documents" before testing fitting to each other. It seems that getting OTC testing cleared by FDA is only one aspect of starting OTC sales. This sounds like a lot more laws have to changed as well which could require even more time. Is this correct here or have I missed something ?
"While the CDC stops short of recommending any specific test product, routine tests are enabled by the advent of rapid, inexpensive HIV tests such as OraSure Technologies Inc.'s OraQuick rapid HIV antibody test, which takes 20 minutes to determine if a person is infected with HIV. The test price ranges from $11 to $17 depending on the quantity ordered."
I don't get how $11 at minimum can be named inexpensive. Seems like OSUR was ghostwriting this article one more time again.
Based on this article I would say that US OTC is a long-term thing which is especially bad for OSUR which has a very important near-term focus on this and is in danger of creating currently false expectations. It is not too bad for Calypte because they get extra time to work on FDA and other basic approval things in the meantime and can reduce its "US regulatory handicap" in this way before things really heat up.
Calypte must be very focused to China and Africa in the short-term anyway (they cannot hit all markets at the same time realistically - my personal opinion) because they would have problems to pursue every opportunity at the same time.
The big cows (markets) to milk within the next one or two years are China/Africa markets and not US OTC. So Calypte's focus looks quite ok for the moment.
Some quick thoughts
Cal
Absolutely,
he has a long successful career already and a reputation to lose so he must be very confident.
Apart from that he moves from Europe to Oregon which is quite a decision too privately. He seems to be convinced that this will a long-term thing for him.
And Calypte is not an unknown adventure for him at this stage. He had nine months to understand what is going on with this company and what the job will require.
Will be interesting to listen to him on the next CC.
Thanks sower for clarifying this issue
your picture is more accurate and my expectation is probably too optimistic.
Roger Gales becomes CEO, takes permanent position
Say what you will but this company always surprises us
-----------------------------------------------------------------------------
Calypte Appoints Roger I. Gale as President and CEO
Monday May 8, 7:30 am ET
LAKE OSWEGO, Ore., May 8 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV - News; the "Company"), medical diagnostic tests manufacturer for the professional point of care (PRO) and over the counter (OTC) segments of the market primarily for the detection of antibodies to the human immunodeficiency virus (HIV), announced today that Mr. Roger I. Gale, Chairman of the Board since November 2004, has been appointed President and Chief Executive Officer. Mr. Gale will relocate to the Company's corporate offices in Portland, Oregon.
He has held the position of interim CEO since October 2005. Mr. Gale will dedicate his full attention to Calypte and has concurrently resigned his position as Executive Chairman of WaveCrest Group Enterprises Limited ("WaveCrest"), an International Communications Services Provider.
Mr. Gale is one of two Directors originally appointed to Calypte's Board pursuant to an August 2003 agreement between the Company and Marr Technologies BV ("Marr"), the Company's largest stockholder and strategic/joint venture partner. He brings not only the knowledge of Calypte he has gained over the past one and a half years, but also his proven effectiveness in building and maintaining the company's strategic relationship with Marr.
Mr. Gale commented, "I am honored to lead the Company at this critical juncture. As Chairman, I have directed Calypte's transition from a lab-based diagnostic company to a lean, point of care diagnostic testing company. We are entering new markets in both the professional sectors and, for the first time, the Over-the-Counter or OTC markets. We now have approvals in parts of Africa, Southeast Asia and the Middle East, and are expanding that reach on a steady basis. We have worked hard to position ourselves in China, which is currently the largest potential market for HIV/AIDS testing. Marr has been a strong partner for us in China, and is not only assisting us in monitoring the Chinese FDA approval process, which we expect to conclude this year, but has already assisted us in establishing a sales and marketing plan for our Joint Venture to take full advantage of the vast opportunities that China has to offer."
Mr. Gale continued, "As we continue to implement our strategy for China, we have the opportunity to monetize the multi-million dollar investment that we have made in intellectual property rights. We have begun the initial steps to launch what will ultimately be an HIV-1/2 OTC OMT (Oral Fluid) test in the U.S., as well as a line of other diagnostic tests that detect a variety of other Sexually Transmitted Diseases. We are also seeking to secure a facility in the Portland area in which we would bring together the staff in our R&D and corporate headquarters, adding manufacturing capability for these new products. We expect to bring this facility on line with the objective of initiating the U.S. FDA approval process by year-end -- without any disruption to our current international plans.
Mr. Gale's background includes considerable international experience. Since October 2001, Mr. Gale has served as Executive Chairman of the Board of Directors of WaveCrest. From 1999 to 2001, he was Chairman and co-founder of End2End Wireless Limited, a UK wireless access services provider. From 1996 to 1998 he was Chief Executive of the OPIC-guaranteed AIG-Brunswick Millennium Fund based in Russia. In addition, he has held senior positions with the Asian Development Bank (ADB, Manila) and the International Finance Corporation (IFC), the private sector arm of the World Bank in Washington, D.C. He serves as a Director and as Chairman of the Audit Committee of Mechel Steel Group, (NYSE: MTL - News). Mr. Gale holds a Master of Economics degree from the University of New England, Australia, and a Higher National Diploma from the Royal Agricultural College, Cirencester, England.
The Company will release its first quarter 2006 financial results on May 15, 2006 and will schedule a conference call at that time.
A key to understand Calypte's business approach
This is info from Linda. It is worth getting posted here again:
Oral testing is clearly preferred by patients/people in lesser developed countries which will lead health care institutions (not all of them but some) to prefer Calypte's oral test over rapid blood tests, even at higher prices.
--------------------------------------
Nitika Pant Pai, Rajnish Joshi, Archana Wankhade, Sandeep Dogra, Madhukar Pai,
Deepak K Mendiratta, Pratibha Narang, SP Kalantri, Jacqueline P Tulsky, Arthur L Reingold
University of California at Berkeley and San Francisco, Mahatma Gandhi Institute of Medical Sciences, Sevagram, India
Background:The OraQuick Advance® HIV1/2 test, using oral mucosal transudate samples, has not been adequately evaluated in rural India. We conducted a cross sectional study in patients at high risk for HIV infection, attending a rural hospital in Central India. Our objective was to determine the acceptability, feasibility and preference of the study participants for HIV tests (rapid oral, rapid finger prick, ELISA and Western Blot).
In this preliminary report, we present the results of the first 150 participants.
Methods: Participants were administered two rapid tests in parallel, and blood was drawn for ELISA and Western Blot concurrently. Face to face interviews using questionnaires were conducted to assess acceptability, pretest and posttest experience, test preferences, and feasibility.
Results: All the participants accepted testing after pretest counseling. A majority (78% of 150) favored oral tests to blood-based tests (finger prick and venepuncture). We questioned participants on discomfort experienced with various tests. 4% of the participants reported discomfort (itching, pain) with oral rapid test; 42% of the participants reported pain, bleeding, and fear of blood with finger prick rapid tests; 24% of the participants reported fear of blood draw, pain on repeat punctures, bleeding, swelling and pressure with use of tourniquet with venepunctures. A majority (66%) of the participants preferred the oral rapid test over blood-based tests. For re-testing, 78% of the participants preferred oral rapid tests. With respect to the timing of test results, a majority (66%) desired results in two weeks, and 17% desired results in one hour.
Conclusions: From this preliminary data, it appears that oral fluid testing is culturally acceptable and is the preferred option in the rural Indian population we studied. Similar studies are needed in different regions of India to determine cultural acceptability, patient preference and feasibility for various HIV testing alternatives.
Presenter: Nitika Pant Pai, MD, MPH Email: nitika@berkeley.edu
Institution: University of California, Berkeley
Ted's comment in CC
Hi sower,
I think it was professional by Ted not to get into a lengthy discussion about how and when sFDA could respond. And he wanted to make that very clear before anybody could have started a phantom discussion in the CC.
The company might have a certain expectation (we don't really know) but at the end of the day they don't know it too and they cannot really influence it at this stage.
They said the normal case is a 100 days period and hopefully all those people from the message boards have understood that the company has not expressed the expectation that they will have clearance in 100 days.
Just like to add that this was not a "promise" by the company like some clowns from other message boards always want to make the rest of us believe in order to ruin the credibility of the company's management. The management currently in place never gave a promise, it made (and makes) forward-looking statements and offer plans (which can change in the future).
Now, I have to admit that I'm more optimistic than you as far as market clearance in China is concerned. I think sFDA will respond in May and the response will be positive (probably not perfectly positive but it will become clear in May that clearance will occur and refusal won't). The HIV story is a political issue in China and so the authorities know they have to do something about it. It is not the usual foreign company only trying to make money on the backs of Chinese people. Calypte will give something important to China.
However I'm less optimistic than you as far as the financing is concerned. I think it will be quite tough. Calypte will sure get their money but I don't expect a deal with great conditions at this stage.
Let's see how it turns out.
Cal
Hi sower,
my feeling was generally that the company should not have any idea how the sFDA feedback will be.
However, it was a bit strange how during the last Q&A session somebody asked what the company expects or if they have any idea already how the feedback could be:
-----(your transcript)-----
Brian Davidson: Yah, it’s important, a hundred days from February. And then I was going to ask, Chris, is there any historical precedent? Does anybody have a sense as to whether you are going to have a strong probability of getting comments?
Ted Gwin, CFO: Let me answer that question. From the experience from the Epitope days with the oral fluid test, if the US FDA is any indication, we expect to have additional comments and questions come back and their going to be asking for additional data. That’s our preliminary guess, we have no indication at this time, how it’s going to turn out. And they have no reason to respond at all until that hundred day clock has run out.
---------------------------
You cant't see it from the transcript but my impression from the audio was that Ted Gwin jumped in pretty quickly like someone trying to disrupt any more disclosure or discussion about this.
Just my impression, could be totally wrong but probably they could indeed have more distinct info or expectations. We will see.
I'm very interested in the financing, especially in the question who is putting money on the table this time.
Is it Marr again, at least Marr (because nobody else with deep pockets likes the story ?) or is there somebody new who believes that the compabny will make it finally. This gives us an impression how the markets feel about Calypte at this stage.
coinstarz mentioned in just the message before your message that the fianncing won't be easy so let's hope they can arrange this again.
Good luck
Cal
Hi coinstarz,
thanks for this info. I was wondering whether you have discussed the upcoming financing with Tim too (oh, you sure have).
Could you give us some insight about how Tim commented on the present activities related to raising more money. Could it happen soon or is it difficult for the company this time to attract further investors?
Thanks
Cal
CC: clear info with balanced realistic description
This is what a CC is all about. We know now where we stand and even more important where we not stand. I like what Roger brings to this company.
I really liked it though we have learned that it once again takes probably more time than expected (and obviously more funding too). So everyone is reminded to take off the rose-colored glasses for the moment in case this hasn't happen already.
However, it might be worth thinking about why a company with 16 people (right?) will soon have a manufacturing facility in place that has a capacity of 10 Million tests per month (not per year, it is 120 Million tests per year only for the Chinese market).
We are just one approval decision away from it.
How many prisoners has China ?
How many students start at China's universities every year ?
There are many interesting aspects to discuss. Stay tuned and keep faith.
Cal
Kenya: another chance to stay alive through 2006
The company needs one contract from Kenya until summer and this would be a big relief as far as financing is concerned.
2006 is the critical year for the company, there can be no doubt that sales numbers will be there in 2007 and the upcoming years (China, Africa, BED, ...) but I feel that 2006 is the bottle neck.
If the company makes it through 2006 we can keep our shares for several years and enjoy the view on how the commercial potential slowly but steadily unfolds.
Good luck
Cal
Brandnew article about Calypte's oral test
(Dedicated to Sower for running this board):
These are essentials of the publication from Toby Gottfried and Ronald Mink published in a journal called Expert. Rev. Mol. Diagn, 139-144 (2006). (www. future drugs.com). The article is not freely accessible online.
This publication relates to the results of the Chinese trials (year 2005) which were used for the filing to the sFDA. The article also describes the results from trials done in Thailand. The results are excellent as it was published by the company some time ago so I don't repeat it here again. Nevertheless, the following additional aspects have been especially interesting to me:
1506 persons have been tested in this trial. 109 of them have been infected with Hepatitis C virus, 60 persons have had other diseases. 37 persons who were known HIV positive and receiving antiretroviral therapy were also tested.
First of all Calypte's oral test has thoroughly tested in terms of cross-reactivity with Hepatitis. From the 109 Hepatitis positive persons tested, all 109 have been identified correctly as HIV negative. There was no false positive with the rapid OMT test of Calypte. I personally find this remarkable because it seems that Oraquick, the only other commercial oral HIV test marketed by OSUR, seems to produce some false positives with Hepatitis-infected persons.
Calypte's test also worked equally well with persons on antiretroviral treatment. I would not have completely excluded that the testing of such patients is more difficult because they might have lower virus levels and thus lower antibody titer. Just my uneducated speculation (which could be naive) but in any case the test worked very well with these patients too.
Additional remarks apart from the trial results which I found remarkable:
1) A long-disputed topic: The price of Calypte's oral test. The article clearly states that the price of the oral test is competitive. The following two statements are cited from the publication:
"The cost per test for rapid tests [relates to all blood rapid test on the market] is slightly higher than ELISAs falling in the US$ 0.24-1.27 price range". [...]
"The Calypte AWARE HIV-1/2 OMT is an economical test, selling well within the cost range of rapid tests above."
2) "The ability to test for HIV without the need for a blood sample has been demonstrated to significantly increase voluntary testing rates."
Interesting to me because this is frequently mentioned but I don't have a lot of info that indeed prove this. The article refers to another publication which gives good data. It is a study done in Uganda with the former Calypte urine EIA (now Maxim). One result was that 14.3% more subjects provided urine than blood. There is another remark from a survey of 180 women in a New York family planning clinic: 21 % of those women declined HIV testing cited reluctance to have a blood draw as a reason for their refusal.
The reference is Sex. Transm. Dis, vol 26 (10) 1999, p. 590-592
3) "In sub-Saharan Africa only 75% of the blood is screened for HIV antibodies due to cost". Simply amazing to me. This published in the journal called Transfusion, vol. 45, Feb. 2005 page 133ff (no free access):
4) "There is an unknown window period for development of oral fluid HIV antibodies."
It is known that it takes months after the infection with HIV until the antibody appears in the blood stream of the infected person. That is the reason why the typical HIV blood test can detect infection only months after the infection has actually occurred. The article states that nobody knows if the antibody appears in oral fluid earlier, later or at about the same time than in the blood stream. Nevertheless, the trials with the oral test revealed that this is no problem as all infections detected from blood by the reference tests have been also detected with Calypte's oral test.
5) "The recent successful performance of AWARE HIV-1/2 OMT with oral fluid specimens, which cover the broad range of HIV subtypes in the develping world along with the inexpensive dipstick format, make it an attractive alternative to fingerstick whole blood." (cited from the publication)
I like to add for comparison the following sentence from an another reference which features the oral test of OSUR (Oraquick).
The reference is Expert. Rev. Mol. Diagn. 4(5), 587-591 (2004), (no free access online access):
"Despite the simplicity of the OraQuick ADVANCE Rapid HIV-1/2 test, the cost is relatively high, presenting a challenge to its widespread use in resource-limited settings." No further comments except that this might illustrate why OSUR is quite active in marketing the test in USA, and also focuses its additional efforts on markets like Europe, Singapur, Korea but not on developing world markets and also not China.
6) My personal highlight of this article:
"The adaptation of a successful rapid test platform to sample types other than blood and infectious diseases, such as tuberculosis and malaria, is the future trend in point-of-care testing. Although urine as a specimen in HIV testing is now FDA approved as the Maxim HIV-1 urine EIA and Urine HIV-1 Western Blot (previously Calypte Biomedical products), the development of a highly sensitive urine HIV-1/2 Rapid test is proving to be challenging. Among the many advantages for urine as a test sample are greater sample stability (even at high temeratures) than any other sample and abroader test menu range for HIV-related conditions, such as pregnancy, sexually transmitted diseases, abuse of drugs and general urinalysis."
and
"Curbing the transmission of tuberculosis and malaria in Africa is now receiving the attention of international funding organizations"
I always wondered why the company seems to prefer the urine over the oral test. At first sight it seems easier to draw an oral sample than an urine sample, isn' it? Now this is probably the reason. With urine, a full menu of diseases can be monitored after drawing only one sample. Great, an integrated rapid test platform for all relevant diseases. I remember from one of sower's transcripts wherein Dr George once said that there are even bigger markets than HIV detection Calypte is targeting in the long run. This is probably one the long term strategies we heard before when Dr George resigned. My speculation here.
Painfully establishing all these distribution and sales channels in the third world could even pay off bigger in the future when the company could one day market such an integrated rapid test platform. Now lets only hope they reach profitibility in 2006 and go on with these plans.
Hope the company keeps the fire burning.
Good luck.
Cal
OSUR update: discussion with FDA about OTC test
http://biz.yahoo.com/bw/060309/20060309005461.html?.v=1
Coinstarz look at this:
http://www.nasdaq.com/reference/inet.stm?&symbol=hiv&selected=hiv
At 10.40 am this shows an usual ratio of buy/sell orders (410:27). Don't really know what it means but looks good.
Cal
P.S.: The link is probably updated already when you read this message
coinstarz this sounds reasonable
Approval in China can happen very soon. It is reasonable to assume that it may even happen until end of March which would be a great day for every long but also every daytrader because this should move the pps very significantly. Therefore I would expect that there will be a larger number of traders buying in in the second half of March (after the delisting issue is clarified -in either way- and the approval starts to look imminent). Normally the market anticipates such an event some time before it actually happens so this stock should move several weeks before. We don't see this already.
Why? The possible AMEX delisting might be the reason although I don't feel such an event would be as negative as the approval would be positive. There is probably a lot of money waiting to get invested soon after March 13.
Just a thought
Cal
Question to Board: AMEX delisting already priced in now ?
Your thoughts ?
Cal
100 share blocks
Someone mentioned earlier that bigger buyers are doing this in order to mask the size of their trades.
Cal
coinstarz
it looks to me that the company has very thoroughly prepared the filing to the sFDA. Getting the filing accepted within days after submitting it is unusual and indicates that the authorities have been involved. We also know that Dr. Mink have been in China in October (or November?) probably to deal with several issues but the filing was sure a topic too.
You touched an important point:
But we never know what the political issue going to come out with HIV.
If a foreign company goes to China in order to make profits there, China will be reluctant to open the door until there is no extra advantage for the country. That is why most companies form joint ventures otherwise they get discriminated in terms of business.
In Calypte's case there is obviously a huge advantage for China, the disease is threatening the country in general so I would expect that the approval process should be very smooth.
Another question in the future will be the copying of the oral test. It will be tough to protect the intellectual property rights of such a test. But I don't think that this should be our concern at this stage.
Cal
coinstarz - expedited review
I was a bit surprised that expedited review was discussed earlier by the company in CCs but actually not touched in the PR.
Typically a company won't be shy of announcing expedited review when it is granted (it is a positive). One could even speculate that it would be good practise to announce it because it is a material event (just my opinion) and will affect investors' decisions.
So one conclusion could be that Calypte has not received priority review (or not yet, I don't know).
However, the company also took its time to announce the filing to the sFDA recently. I think they announced it almost two weeks after it actually occurred. So I would not be surprised if they have indeed expedited review (or some status effectively equivalent) but have not told us yet. One possible reason for not mentioning it, is the realistic expectation that approval will be received soon.
It seems that the company is now very cautious when announcing info publically, which is a change to earlier times. Possibly this is due to the confusion that built up after Roger Gale indicated twice a CC without doing it afterwards. People might have phoned the company for weeks and complained about it.
This leads also to the question whether there is significant progress on other fields which has not been made public yet. We don't know.
Cal