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Biotech / Medical : Trinity Biotech (TRIBY)

TRIB 0.960

-4.0%

Dec 5 9:30 AM EST

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To: Ron Luhmann who wrote (7319)	10/31/1997 8:04:00 PM
From: nic	Read Replies (1) of 14328

we must be close to Uni-Gold HIV approval by now? Not necessarily - I received this clarification from Olga Fleming at Lippert/Heilshorn & Associates (TRIBY's PR firm): Trinity has ALWAYS stated that the launch of the HIV test in the U.S. will take approximately 18-24 months from its original FDA filing date (December 1996). Why? Because the HIV test is not going through the same FDA approval process as other diagnostic tests, given the nature of the disease. You can agree that the FDA will want to take its time to thoroughly evaluate a one-step HIV test before introducing it to the market. But, the HIV test is being sold to other nations worldwide. Of course this is a conservative (if not worst-case) scenario, but given the FDA's track record it may be risky to speculate on a much speedier process... TRIBY has many other things going for it, but at this point I'm not holding my breath for HIV Uni-Gold FDA approval. - nic

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