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Biotech / Medical : Gliatech (GLIA)
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To: scaram(o)uche who wrote (1813)10/16/2000 8:21:32 PM
From: scaram(o)uche  Read Replies (1) of 2001
 
(continued)

Gliatech has addressed the internal systems (SOPs and resources) in
order to enhance Good Clinical Practice (GCP) compliance. We have performed
additional reviews based on the current observations and added new SOPs that
address many of the specific concerns that were raised in the Form FDA 483. We
are currently in the process of comprehensively assessing the systems and
resources for managing Gliatech clinical studies, as well as the re-training of
all employees involved in clinical studies in GCPs. We believe that the above
actions will enhance the existing procedures and further improve the manner in
which we conduct clinical trials.

(snip)

[ I believe, but do not guarantee, that these excerpts pretty much cover the guts of the disclosure. Please do your own research and homework. ]
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