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Biotech / Medical : Gliatech (GLIA)
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To: Torben Noerup Nielsen who wrote (1700)8/29/2000 11:38:28 AM
From: Bill Tomko  Read Replies (1) of 2001
 
I spoke to GLIA IR and tried to get some clarification.
ADCON-L was approved mostly upon European data and the interium US clinical studies with a promise to complete the clinical studies and submit a supplemental PMA. WHich was done in I beleive 1998. The FDA came in to audit the filing this June 2000. The 483 relates to the supplemental PMA filing. At no time did the FDA mention pulling the prodcut from the market.

I INFERRED that the 483 MAY be JUST ONE of many reasons this merger was terminated. I strongly urged them to hold a CC at the ealiest possible time,explain the 483 and come clean on why the merger fell apart.
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