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Biotech / Medical : Trinity Biotech (TRIBY) -- Ignore unavailable to you. Want to Upgrade?

To: nic who wrote (7321)	11/1/1997 10:23:00 AM
From: David M Gambs	Read Replies (1) \| Respond to of 14328

nic, all; Federal law requires the FDA to complete their process for approval/disapproval within 12 months. The FDA has been very slow, taking between 18 & 24 months to accomplish what is supposed to take no more than 12 months. A recent statement from the FDA indicates that they now have their process down to 12 to 18 months. Late December 1997 will be twelve months since the UNI-Gold HIV test was submitted. We may be looking at June 1998 as an approval time frame. Regards, dmg