Calypte und die Zeit nach AIDS2004 in Bangkok
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Wertpapier: Calypte Biomedical |
Type Value Conf.
resist. 0.43 2
resist. 0.42 6
resist. 0.40 2
resist. 0.38 6
resist. 0.37 6
resist. 0.36 3
resist. 0.34 2
resist. 0.33 7
resist. 0.32 3
resist. 0.31 3
resist. 0.30 4
supp 0.26 8
supp 0.25 2
supp 0.24 2
supp 0.23 2
supp 0.20 8
PLEASANTON, Calif., March 7, 2005 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (Amex: HIV) today announced a progress report on the Chinese clinical trial program of its rapid HIV-1/2 tests in The Peoples Republic of China (China). The ongoing trials are evaluating the sensitivity and specificity of the Company's three rapid HIV-1/2 Antibody Tests; Blood, Oral Fluid and Urine. The trials are also evaluating the Company's HIV-1 Western Blot supplemental tests in blood and urine.
The Chinese clinical trial program is currently testing approximately 1,500 patients comprised of known HIV antibody positive subjects, high risk subjects, special situation subjects and low risk subjects. It is our understanding that the collection and testing of HIV positive subjects has been completed and the collection and testing of the other subjects commenced immediately after the Chinese New Year. The Company expects to complete sample collection at all trial locations in the coming weeks, with a full statistical analysis available approximately two weeks after the last patient has been enrolled. The results of this program will form the basis to file the required regulatory applications with the Chinese FDA (SFDA).
Dr. Richard George, President and CEO of Calypte said, "It is difficult to predict how long a complex project like this will take. As a result of a delayed start, the Chinese New Year, and bad weather which required that we furnish heaters to the trial sites to maintain the test protocols, the trial will be completed later than we had originally projected. Nonetheless, we are encouraged by the feedback that we have received from the field to date and believe that all 3 of our rapid HIV-1/2 tests will meet the accuracy standards that have been employed by the Chinese SFDA in past rapid HIV test approvals. We await the final statistical report to assess firm conclusions and underscore our confidence."
Dr. George continued, "Based on our understanding of the current Chinese regulatory submission process, we still expect to receive a response from SFDA around mid-2005, which would not alter Calypte's launch of its rapid HIV testing platform in China as originally projected during the second half of 2005. In parallel to the regulatory process, the Company has continued to advance its manufacturing strategy. Based on these efforts we expect to have production available to support the launch into China subsequent to regulatory approval."
There are a reported 840,000 adults and children in China living with HIV/AIDS today, and according to the Bill & Melinda Gates Foundation, China is one of the "next wave" countries where the number of infections is expected to grow to 15 million by 2010. China has recognized this problem and acknowledged its testing gap. The annual AIDS testing level is currently estimated at 1.5% of the population. The Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. Calypte believes that the only effective way to manage such numbers is to utilize trained non-professionals to administer a program based on safe, alternative fluid- oral fluid or urine - testing. There are other focused, and large markets within China where testing is mandated, such as population control, prisons and immigration.
About Calypte Biomedical:
Calypte Biomedical Corporation, headquartered in Pleasanton, California, is a healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 Incidence EIA as well as tests that can determine HIV antibody status without the need for blood. Calypte is engaged in developing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will continue to expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB for the year ended December 31, 2003 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact:
Richard George, President and CEO Tim Clemensen
Phone: (925)730-7200 Rubenstein Investor Relations
email: rgeorge@calypte.com Phone: (212) 843-9337
email: tclemensen@rubensteinir.co
das ist nichts als ein zwischenbericht, in dem nichts neues steht!!!
im gegenteil, die ergebnisse verzögern sich wie so oft...
ihr geht heute noch ins minus....
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...Dr. Richard George, President and CEO of Calypte said, "It is difficult to predict how long a complex project like this will take. As a result of a delayed start, the Chinese New Year, and bad weather which required that we furnish heaters to the trial sites to maintain the test protocols, the trial will be completed later than we had originally projected....
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lächerlich...
eine antwort bez. der zulassung wird es erst mitte 2005 geben...prust...
...Dr. George continued, "Based on our understanding of the current Chinese regulatory submission process, we still expect to receive a response from SFDA around mid-2005,...
das wird sich bestimmt auch wieder verzögern bei caly.
leute, wischt euch mal den sand aus den augen, da kommen dieses jahr keine aufträge mehr. bis dahin werden noch viele aktien ausgegeben werden...oh mann...
das war es dann mal wieder mit dem kursanstieg, gleich geht es wieder runter:
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Well we lied...
We still haven't finished yet, 14 weeks later. Lets blame bad weather and the Chinese New Year.
Is anyone surprised?
Wonder who will be gone by April Fools day?
http://ragingbull.lycos.com/mboard/boards.cgi?board=CYPT&read=66305
I think management said it was lying around here somewhere wasn't it?
Wonder how Tim "the parrot" Clemensen is doing without Tony putting words in his mouth?
Actually the PR almost looks truthful.
Hey we lied earlier. We still aren't finished yet.
The part that looks funny is the "bad weather" and "Chinese New Year" excuses. "Gosh we didn't expect either one of those to happen in China."
Another thing is that the company admits that the tests are not completed and results are not in, but hint that they will be good. Wonder how they can determine that without all the results being in? Sounds like Tony still has a presence, albeit a small one, at HIV.
http://ragingbull.lycos.com/mboard/boards.cgi?board=CYPT&read=66307
1. Magic Johnson is contracted to help brand Calypte
Magic Johnson is one of the most successful businessmen of our time..with strong ties to the media
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Magic sucking a million dollars a year from Calypte and has not joined the Board of Directors as per his contract or made any public service announcements as per his contract.
In fact in his one public appearance in 2004 with HIV officials at AMEX Bell Ringing he did not mention Calypte even once.
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2. Scientists are running the company with strong ties to WHO and CDC
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Of course they haven't even filed for WHO approval yet for any of their rapid tests.
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3. Luc Montagnier who discovered HIV 1 is affiliated with the company another strong tie to CDC
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Hmm missed his name on the HIV Board of Directors or officers list.
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4. They have the only FDA approved Urine Based Test..
Urine will be the choice among Africian natives who do not want ###### or swabs performed
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First they are not even approved to manufacture this urine lab test at this time for anyone at their only US plant in Rockville.
Second as per company SEC filing the Africans would not buy this urine lab test. Wanted to wait for cheaper and quicker rapid test. Also HIV hasn't yet shown why the African or others will pay 150% more to buy their rapid tests either, when and if they are finally approved.
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5. They have the best marketing,packaging and name with the AWARE(tm) brand of HIV tests
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ooh ooh that name is just everywhere isn't it . Too funny.
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6. the market for other STD tests is larger and they already have urine based tests ready to hit the market soon after theri HIV takes hold
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Yep just waiting on that first approval from anywhere.
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7. Certain company executives are former Orasure employees
utilizing their contacts to move Calypte forward
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Yep Calypte got them after Orasure said goodbye.
How desparate they must have been to come to work for Cataldo.
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Der Test soll von Nichtfachleuten ! sicher! ausgeführt werden können ! und zwar mit
Speichel und mit Urinschnelltests !.
TIC TAC TIC TAC
"The Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. Calypte believes that the only effective way to manage such numbers is to utilize trained non-professionals to administer a program based on safe, alternative fluid- oral fluid or urine - testing."
Holder Shares % Out Value* Reported
Stark Offshore Management, LLC 10,000,000 5.91 $3,000,000 4-Mar-05
Thomson Horstmann & Bryant, Inc. 700,000 0.41 $210,000 4-Mar-05
Barclays Bank Plc 420,398 0.25 $126,119 4-Mar-05
M&T Bank 338,300 0.2 $101,490 4-Mar-05
Calpers (California-Public Employees Retirement System) 251,700 0.15 $75,510 4-Mar-05
Citigroup Inc. 14,836 0.01 $4,450 4-Mar-05
Deutsche Bank Aktiengesellschaft 8,500 0.01 $2,550 4-Mar-05
Regent Atlantic Capital, LLC 1,066 0 $319 4-Mar-05
New Star Asset Management Group Ltd 1,000 0 $300 4-Mar-05
UBS Securities LLC 91 0 $27 4-Mar-05
TOP MUTUAL FUND HOLDERS
Holder Shares % Out Value* Reported
MTB Small Cap Growth Fd 3,731,500 2.2 $1,119,450 4-Mar-05
MTB Multi-Cap Growth Fd 3,259,600 1.93 $977,880 4-Mar-05
Massmutual Institutional Fds-Small Company Growth Fund 1,717,000 1.01 $515,100 4-Mar-05
Quantitative Master Series Tr-Extended Market Index Seri 16,300 0.01 $4,890 4-Mar-05
Spartan Extended Market Index Fund 656 0 $196 4-Mar-05
glaubt ihr das im ernst? wenn das keine ente ist, dann werden sie einen bluttest nehmen, der dann nur ca. 1,50$ bzw. weniger kostet...aber da sind ja gottlob schon welche auf dem markt, damit die chinesen nicht mehr auf caly warten müssen...
Adaltis Inc. has received important orders from customers in China to supply a total of 1.5 million HIV rapid tests. Amongst these customers are the Chinese Red Army, as well as several regional Centres for Disease Control (CDC).
"We are extremely pleased to be able to provide high-quality products to assist the Chinese government control the spread of HIV," declared Pierre Larochelle, president and chief executive officer of Adaltis. "These initial orders constitute an important step in the execution of our plan to become a leader in the HIV field in China."
"We are beginning to see the initial results of the substantial sales and marketing efforts of the last several months," stated Dr. Raymond Tong, president and chief executive officer of Adaltis Asia. "Establishing commercial relationships with these reference clients is an excellent entry point to establish our HIV product offering in the Chinese market. With the upcoming launch of our HIV microplate in China in the second half of 2005, we will be able to offer our Chinese customers a more extensive offering for HIV diagnostic testing."
Singapore mulls HIV self-test kits as infections rise
SINGAPORE, March 9 (Reuters) - Singapore said on Wednesday it was studying the use of over-the-counter HIV test kits for early detection following a jump in the number of new cases last year.
"These test kits are easy to use because they test the saliva. This will allow those at risk to test themselves," Senior Minister of State for Health Balaji Sadasivan told parliament.
The number of new HIV/AIDS cases in Singapore rose 28 percent to 311 last year, up from 242 in 2003, he said.
The minister said 90 percent of newly diagnosed patients were male and a third of them were gay men.
Although the wealthy Southeast Asian island has one of Asia's lowest levels of HIV infection, it is tightening defences due to the jump in cases, notably among gays and hetrosexual men who have casual sex.
The government is also studying proposals to make testing of pregnant mothers compulsory.
Sadasivan said 77 percent of pregnant women were now screened for HIV/AIDS and this had saved at least one child from being infected in the last two months.
The minister said it was not clear why the rate of HIV infection had risen sharply among gay men.
An epidemiologist had suggested it might be linked to the annual Nation Party, a predominantly gay party, he said.
Singapore has more than 2,000 HIV/AIDS patients but for every patient diagnosed, there were possibly as many as two to four cases that are undetected, he said.
Singapore could have anywhere between 4,000 and 8,000 undiagnosed HIV patients, the minister said.
Aids activists in Singapore have urged the government to decriminalise homosexuality to help promote AIDS awareness in the community. Under Penal Code section 377A, acts of "gross indecency" between two men are punishable by up to two years in jail.
derzeit muß ich zu allen aidsberichten sagen: schön und gut, aber was wird aus caly? trinity wird da schön verkaufen und orasure wohl auch. hier dei letzten zahlen von orasure. die erlöse werden immer höher und auch orasure hat bald den break-even erreicht. auch sie profitieren wie trinity vom wachsenden markt. nur calys zahlen bleiben grottenschlecht. die meldung ist zwar schon vom 10.02.05 aber bezeichnend für calys wachsendes desaster aufgrund verlorener zeit:
OraSure Announces Record Financial Results
BETHLEHEM, Pa., Feb 10, 2005 (BUSINESS WIRE) -- OraSure Technologies, Inc.
(NASDAQ: OSUR), the market leader in oral fluid diagnostics, today announced
record revenues of $54.0 million and $14.2 million for the year and quarter
ended December 31, 2004, respectively. Full year 2004 revenues represent a 34%
increase from the $40.5 million in revenues recorded for 2003. Revenues for the
quarter ended December 31, 2004 were 20% higher than those for the same period
of 2003.
The Company also reported a net loss of $0.6 million, or $(0.01) per share, for
the full year 2004, and a net loss of $245,000, or $(0.01) per share, for the
fourth quarter of 2004. This compares to a net loss of $1.1 million, or $(0.03)
per share and a profit of $435,000, or $0.01 per share, for the full year and
quarter ended December 31, 2003, respectively.
"We are very pleased with the Company's fourth quarter results leading to a
tenth consecutive quarter of record revenues," said Douglas A. Michels,
President and CEO of OraSure Technologies. "Each of our product lines continued
to experience growth in the fourth quarter with notable gains in Substance Abuse
Testing and Cryosurgical Systems. Our performance in 2004 has put us in position
for great success in 2005 and beyond."
The increase in 2004 full year revenues was primarily the result of increased
sales of the Company's Freeze Off(TM) wart removal product, OraQuick(R) rapid
HIV antibody tests, and Intercept(R) oral fluid drug testing system. These
increases were partially offset by a decline in sales of assays in the insurance
risk assessment market. Product revenues were a record $53.6 million for the
full year 2004 and a record $14.1 million for the quarter ended December 31,
2004, representing increases of 35% and 20%, respectively, over the comparable
2003 periods.
ABBOTT PARK, Ill., and BETHLEHEM, Pa., Feb 14, 2005 /PRNewswire-FirstCall via
COMTEX/ -- Abbott (NYSE: ABT) and OraSure Technologies (Nasdaq: OSUR) today
announced an agreement for the distribution of OraSure Technologies' OraQuick(R)
ADVANCE(TM) rapid antibody test for the detection of antibodies to the Human
Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2). Under the terms of the
distribution agreement, Abbott was appointed as exclusive distributor of the
OraQuick(R) ADVANCE(TM) HIV-1/2 test for hospitals and as a non-exclusive
distributor to physician offices in the United States.
"We believe this agreement will enable us to capitalize on the growing demand
for our new OraQuick(R) ADVANCE(TM) test and help achieve our goal of making
rapid HIV testing available to all who need it," said Douglas A. Michels,
President and CEO of OraSure Technologies. "With the sales and marketing teams
from OraSure and Abbott working together, we will expand the reach of this
product in the United States."
Providing results in as little as 20 minutes, OraQuick(R) ADVANCE(TM) is the
only rapid, point-of-care test for the detection of antibodies to both HIV-1 and
HIV-2 approved by the U.S. Food and Drug Administration (FDA) for use on oral
fluid, finger stick or venipuncture whole blood, and plasma specimens. The test
is also CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waived
for all specimen types except plasma. OraSure commercially launched the
OraQuick(R) ADVANCE(TM) test in October 2004.