Calypte und die Zeit nach AIDS2004 in Bangkok
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By: joenrw
01 Dec 2004, 05:18 AM EST
Msg. 63626 of 63629
(This msg. is a reply to 63625 by jonas.grumby.)
Jump to msg. #
of course, that will create big contracts for TRINITY....
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Trinty ist nicht schlecht, aber du hast ja keine von dieser Firma und schreibst immer wieder wie gut diese sind und zockst immer in Augrid herum !.
noch ist das spiel nicht ganz vorbei, wenngleich die chancen mit jedem tag sinken...
und da wären wir wieder beim unterschied: keiner ist gegen abzocke gefeit. jedoch muß man diese irgendwann auch erkennen und dann auch handeln.
einsicht und selbstkritik ist jedenfalls bei diesem haufen hier nicht gegeben...
Calypte Biomedical Initiates China Clinical Trials of Rapid Test Platform
PLEASANTON, Calif., Dec. 1 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that it has initiated a clinical trial program of its rapid HIV-1/2 test platform and HIV-1 Western blot supplemental tests in The Peoples Republic of China (China). The trial will evaluate the sensitivity and specificity of the Company's three rapid HIV 1/2 antibody tests: blood, oral fluid and urine. The trial will also evaluate the Company's HIV-1 Western Blot supplemental tests in blood and urine.
Dr. Richard George, President and CEO of Calypte said, "The initiation of the Chinese clinical trial program represents an important milestone in the development of our rapid test platform. We are testing approximately 1,500 patients and expect to complete the data collection by the end of this year."
The clinical trial program in China will evaluate the subjects using no less than 7 locations that will perform the rapid HIV 1/2 tests and using at least 3 laboratories that will perform the HIV-1 Western Blot supplemental tests. The trial is expected to take four to six weeks to enroll the desired 1,500 subjects. The Company expects a full statistical analysis to be available approximately two weeks after the last patient has been enrolled.
Dr. George continued, "In accordance with company policy, we will not provide interim data on assay performance in this clinical trial. However, we will release the performance results when the trials have been completed and certified by our Chinese contractor. Our objective is to file the required regulatory applications with the Chinese FDA (SFDA) in early 2005. Based on our understanding of the current Chinese regulatory submission process, we expect to receive a response from SFDA by approximately mid-2005. We also expect to have production from our manufacturing plant available by that time to support the launch into China, contingent upon regulatory approval, in the second half of 2005. We expect to have an initial production capacity of over 30 million tests per year for the Chinese market."
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 who would be able to execute such a program based on safe, alternative fluid testing -- oral fluid or urine -- HIV 1/2 tests. 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.
Mit Sicherheit bringt das auch wieder nichts !!!!!.
WÜRDE JOELU SCHREIBEN oder?
und das beste ist das: ...We also expect to have production from our manufacturing plant available by that time to support the launch into China, contingent upon regulatory approval, in the second half of 2005. ...
also erst 2 häfte 2005 werden erste umsätze kommen...muhahahahahahhahahaa....
sagt mal lucky und standing...ihr 2 vollblut-rechtschreibexperten...was glaubt ihr, wann ihr wieder unter 0,25$ seid???? muahahahhahahahaa
heute noch im minus???