Da bin Ich nicht allein , so wie du mit Leuten wie Roy the Toy und den anderen nicht allein bist....muhahahah
Yahoo Board:
June 27, 05 Quarterly Report Excerpt
by: bruzzones2000 (49/F/California)
From the Quarterly Report 6/27/05:
Rapid Tests We expect that our future revenues will be derived primarily from the sale of our HIV-1/2 rapid tests. Our focus for 2005 is on commercializing our HIV-1/2 rapid tests, INITIALLY IN A DIP-STICK-FORMAT AND PRODUCED IN THAILAND, from which we believe we can source certain African and southeast Asian markets. WE PLAN TO SUPPLY THE CHINESE MARKET WITH PRODUCT MANUFACTURED LOCALLY IN CONJUNCTION WITH OUR CHINESE JOINT VENTURE OPERATION. Commencement of rapid test sales is contingent upon the successful completion of clinical trials followed by the required regulatory approvals. While we are unable to predict with certainty the level of rapid test revenues in 2005, WE ARE TARGETING SALES IN OUR INITIAL MARKETS OF AFRICA, CHINA AND PARTS OF THE SOUTHEAST ASIA DURING HTE SECOND HALF OF 2005 as we complete the commercialization of our tests, develop our distribution network and familiarize potential customers with the availability and efficacy of our tests.
In China, we have completed the clinical trials on our HIV rapid tests that were conducted by the National Center for AIDS/STD Control and Prevention of the Chinese CDC. The trials involved approximately 1,500 subjects. We are still awaiting a final report on the performance of our HIV-1/2 rapid tests and the serum and urine Western Blot supplemental tests that were included in the clinical trials. WE EXPECT TO USE THIS DATA TO SUBMIT OUR APPLICATION FOR PRODUCT APPROVAL TO THE CHINESE FDA IN THE SECOND QUARTER OF 2005. In parallel with the regulatory approval process, we have continued to advance our manufacturing strategy. We expect to have production available to support a commercial product launch in China subsequent to regulatory approval DURING THE SECOND HALF OF 2005. There are several large markets in China, including a recently announced commitment by the Chinese government TO OFFER VOLUNTARY HIV TESTING TO ITS ENTIRE 1.36 BILLION POPULATION. With trained non-professionals and a safe, non-invasive alternative fluid - oral fluid or urine - testing program employing the products currently involved in the clinical trial, we expect strong demand for our products. Beijing Calypte, our joint venture with Marr, will manage the Chinese rapid test product launch.
We have SUCCESSLY COMPLETED THE REGULATORY APPROVAL PROCESS FOR OUR BLOOD, ORAL FLUID AND URINE RAPID TESTS IN UGANDA. We have completed clinical trials of our rapid blood test in South Africa and are awaiting the final results of the trials there. We anticipate commencing clinical trials of our oral fluid and urine rapid tests in South Africa shortly. We will complete the regulatory approval processes in South Africa as soon as possible upon receipt of the clinical trial results. We also expect to begin additional trials during 2005 in several other African countries. While there are different regulations and customs in each foreign country, we are finalizing or have established distribution relationships in several countries that will be part of these next trials and we believe that the regulatory process can generally be completed within IN A FEW MONTHS.
Gruß
C.O |
Thread abonnieren
