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Biotech / Medical : Trinity Biotech (TRIBY)
TRIB 0.900-4.3%Dec 19 3:54 PM EST
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To: Rob LeVine who wrote (9954)8/4/1998 11:24:00 AM
From: Ron Luhmann  Read Replies (1) of 14328
 
mornin' Tribites ... the FDA has their own site at www.fda.gov
some good info about the Food & Drug Modernization Act (FDAMA)1977
it gives some required approval limits for certain types of submissions

my wife works for a small biotech company in San Diego (they make a personally worn digital cardiac monitor) she recently went to a two-day FDA sponsored workshop for accelerating submission
approval times.

Unigold HIV was submitted 19 Dec '96 as an FDA PMA (Premarket Approval) submission for their unique "Unigold" technology. Timeframe that was put out then was 18-24 months for approval process due to it being "new" technology and the severity of HIV/AIDS infection.
Ronan said in the last conf call he expected the 510(K) submission for Unigold Strep A to be approved in less than 120 days. A 510(K) submission for approval is used when equivalent technology has already been submitted (Unigold HIV)...the FDMA ACT of '97 puts limits on approval times for the FDA and there are several types of 510(K) submission including a 510(K) "special" that is approved in 30 days or less .

I'm posting this for those who didn't know the difference in submissions. Based on what Ronan said and that a 510(K) is based on previously submitted equivalent technology, I'm taking that to mean the HIV Unigold technology previously submitted (HIV) will be approved before the Strep A is. Those who know any more about the process please correct any errors...looking fwd to a "Merry Christmas"...Ron

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