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Biotech / Medical : Trinity Biotech (TRIBY)

TRIB 0.734

-0.9%

Jan 9 3:59 PM EST

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To: PAR who wrote (3008)	11/14/1996 4:37:00 PM
From: gbull	of 14328

Hi, Paula and Others: Spoke with someone at the FDA - Medical Devices division trying to hunt up information and hit the wall. They only publish 510(k) information on submittals that have been approved. No information on pending submittals or preliminary discussions between companies and the FDA are released to the public. You can get 510(k) specific reports by the Freedom of Information act, but get this: If the report has already been released you can get it in a month. If it has not been released, it can take 1-2 years. Deep Breath. All in all, as the man at FDA suggested in his first response, ask the company for the information, Trinity has informed us much better than our government ever will. Which, I have forgotten the submittals at this point. Has anything been submitted and/or approved at the FDA by Trinity? What is supposed to be submitted? Are the Longs out there? This should be allowable information to be dispersed. Yes? No? At least a summary of what has been done is allowable. GB in TN

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