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

To: EagleC who wrote (7828)	1/16/1998 10:00:00 PM
From: AgAuUSA	Respond to of 14328

biz.yahoo.com

To: EagleC who wrote (7828)	1/16/1998 10:23:00 PM
From: Keiko	Respond to of 14328

Mark, Every time I ask Trinity about the status of the Uni-gold HIV test I seem I get the same answer phrased as follows: 1 ) the FDA has responded to our initial request. 2 ) The FDA continues to request additional sera from SE Asia or Sub-Saharan Africa 3 ) The FDA has requested " type O...type H subtypes of the HIV virus from Bangledesh and Boro Boro for further " studies " As I have mentioned before, Trinity has submitted to the mandatory FDA regulatory proctoscope although they still have not made any appearance in Dublin. The Clark facility is ISO approved as is the UK plant. Trinity currently produces the Uni-gold HIV test in Dublin and they are searching for much larger quarters to house an expanding work-force. I presume they will attempt ISO approval at any new location possibly in anticipation of the US FDA inspection team When and if we ever see HIV FDA approval it will truly be a surprise. It is a very simple and fool-proof POC test and that's what makes the approval process so agonizing and tedious to all the folks involved. Our resident FDA guru ( Greg ) may enlighten us on this subject.

To: EagleC who wrote (7828)	1/18/1998 11:31:00 AM
From: Keiko	Respond to of 14328

< Just in time for Happy Hour > O'McGuire, Hopefully, you have recovered from shrinking all those brain cells. Friday was rather interesting heh, now if we can see some follow-through on Tuesday or do we see more games from our friends the market manipulators ? Regarding your question on the approval process for the Uni-gold HIV which was filed in Dec 96. If memory serves my correctly, Trinity has decided to go for a PMA approval since the test is targeted for use in a Clinical setting ( Doctors Office ) rather than the OTC which would simply require a 501k filing. PMA filings require a higher level of study from the FDA and are more time consuming. The reason for this approach IMHO ? Once Trinity gains FDA approval for the HIV serum & plasma test they might ask for approval of the Saliva based Uni-gold PLUS they are now selling the Uni-gold Hepatitis world-wide.( The next logical test for FDA approval since SKB is very invovled with Hep markets world - wide The next logical step of course would be the OTC markets in the US Also , remember , the Uni-gold HIV & Uni-gold Hepatitis B is now selling in the International markets....ie...South Africa....Malaysia....Saudia Arabia..Egypt and Guatemala Great time to visit the Olde Sod !......exchange rate now leaning towards our side of the pond . ( up from 65 pennies last year )Guiness Stout at bargain prices. dna.lth.se