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Packt Caly 1$ ??? o. T.
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öffnest, dann schaffst Du es sofort auf die Ignore-Liste!
J
J
total egal, wenn man fett dran verdient, oder?
total eagl, wenn er mich mit dem Müll andauernd nervt oder?
also maul hier nicht rum ;-)) Oder gönnste uns das nicht?
mit? Is nur n mouse click
dann besser geht? Komische Argumente, aber was soll,s. Klick Dich durch ;-)))
Calypte and World Health Organization Reach Agreement to Accelerate Review Of HIV EIA and Western Blot Evaluations Phase 2 No Longer Required
TUESDAY, AUGUST 26, 2003 9:49 AM
- PR Newswire
ALAMEDA, Calif., Aug 26, 2003 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CYPT), the developer and marketer of the only two FDA approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA approved serum HIV-1 antibody Western blot supplemental test, announced that it has reached an agreement with WHO that additional evaluation of the Calypte HIV-1 Urine EIA screening tests and its Cmabrigde Biotech Urine Western Blot supplemental test is not required. In light of the successful results achieved in Phase 1 trials and the significant costs, and resources that would be required to implement Phase 2 trials, the WHO has agreed to formulate an opinion on the urine algorithm that takes into account the results of its already conducted Phase I evaluation as well as accumulated data from other trials and evaluations performed around the world.
Calypte has agreed to compile a dossier of data related to other trials from around the world and provide it to WHO for its critical review. Pending WHO's favorable review, the Company expects WHO to issue an opinion on the urine EIA / Western Blot algorithm that acknowledges its utility in those settings where appropriate laboratory facilities and personnel are available.
"This agreement is an important step in bringing the lengthy WHO evaluation process to closure. While a favorable opinion from WHO is of obvious importance to Calypte, it is of equal importance to all of those countries that strictly model their HIV policies according to the WHO's recommendations. To date, those countries have been prevented from offering the urine alternative to their citizens because the WHO has not yet issued a statement deeming the urine approach acceptable. Pending WHO's favorable review of the data, we look forward to bringing the benefits of urine testing, such as enhanced safety and patient appeal, to areas where these benefits have not been available before", said Jay Oyakawa, President of Calypte.
Tony Cataldo, Executive Chairman of Calypte added, "We appreciate WHO's flexibility in this matter, and we are confident that our world-wide data combined with WHO's own data will give the agency a sound basis upon which to issue a favorable opinion. We are also in discussion with WHO regarding their evaluation of the Company's rapid tests for HIV."
TUESDAY, AUGUST 26, 2003 9:49 AM
- PR Newswire
ALAMEDA, Calif., Aug 26, 2003 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CYPT), the developer and marketer of the only two FDA approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA approved serum HIV-1 antibody Western blot supplemental test, announced that it has reached an agreement with WHO that additional evaluation of the Calypte HIV-1 Urine EIA screening tests and its Cmabrigde Biotech Urine Western Blot supplemental test is not required. In light of the successful results achieved in Phase 1 trials and the significant costs, and resources that would be required to implement Phase 2 trials, the WHO has agreed to formulate an opinion on the urine algorithm that takes into account the results of its already conducted Phase I evaluation as well as accumulated data from other trials and evaluations performed around the world.
Calypte has agreed to compile a dossier of data related to other trials from around the world and provide it to WHO for its critical review. Pending WHO's favorable review, the Company expects WHO to issue an opinion on the urine EIA / Western Blot algorithm that acknowledges its utility in those settings where appropriate laboratory facilities and personnel are available.
"This agreement is an important step in bringing the lengthy WHO evaluation process to closure. While a favorable opinion from WHO is of obvious importance to Calypte, it is of equal importance to all of those countries that strictly model their HIV policies according to the WHO's recommendations. To date, those countries have been prevented from offering the urine alternative to their citizens because the WHO has not yet issued a statement deeming the urine approach acceptable. Pending WHO's favorable review of the data, we look forward to bringing the benefits of urine testing, such as enhanced safety and patient appeal, to areas where these benefits have not been available before", said Jay Oyakawa, President of Calypte.
Tony Cataldo, Executive Chairman of Calypte added, "We appreciate WHO's flexibility in this matter, and we are confident that our world-wide data combined with WHO's own data will give the agency a sound basis upon which to issue a favorable opinion. We are also in discussion with WHO regarding their evaluation of the Company's rapid tests for HIV."
Pack den Knilch mit ein, wird gleich im See versenkt ;-)))
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