To: Sherman Chen who wrote (188 ) 10/28/1997 11:24:00 AM From: JanyBlueEyes Respond to of 381
It has been approximately 6 weeks since the FDA gave approval pending labeling. We knew that CALY would have to get additional cashflow from somewhere......so now they have it......let's see what they do with it. The fundamentals remain intact. Let's recap a little: -This is the first and only urine based HIV screening & confirmatory test and they already have worldwide distributors set up (see techstocks.com . The following table summarizes the markets and geographic regions covered by the Company and its distributors for its HIV-1 test. Company.....Geographic Location...............Markets Calypte..........United States.....................12 laboratories serving the life insurance,military, ...............................................................immigration and criminal justice markets Calypte............Canada.............................All Seradyn............United States................. All but the above laboratories. Seradyn............Europe, Latin America.....All .......................Africa, Middle East Otsuka.............Asia, Australia,...............All ......................New Zealand Travenol...........Israel...............................All -from the press release - U.S. FDA Issues "Review Complete" Notice for Urine HIV-1 Confirmation Test 9/18/97 siliconinvestor.com ''We believe that urine sampling is an attractive option to blood sampling in many medical settings, including STD Clinics, anonymous HIV Clinics, hospitals, and doctors' offices . We have also received keen interest in the Urine HIV test from <b.institutional testing sites, such as prisons,'' said Dwaine Ogden, vice president of sales and marketing for Seradyn. ''The availability of a Urine HIV-1 confirmation test, once approved, will make the urine sampling option all the more attractive, and we anticipate a major surge of interest as a result .'' -from siliconinvestor.com .................blood donors may ultimately have to be screened with urine HIV tests . The FDA has required the blood supply to be screened for HIV subtype O,with only 2 confirmed cases having been known to be missed with existing blood tests. With 14 confirmed cases where blood testing missed HIV-1 positives and a urine test revealed HIV-1 positives , strong evidence already exists that combination testing would be more accurate.........Currently, in the US there are 45-50 million blood bank screening tests performed annually . Jane