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Biotech / Medical : Pharmos (PARS)
PARS 2.700+13.6%Jan 21 4:00 PM EST
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To: Clarksterh who wrote (1362)12/20/2004 1:30:07 PM
From: NeuroInvestment  Read Replies (2) of 1386
 
As part of the post-mortem for dex's TBI trial:
1) The dex used in this trial was not from the new manufacturing plant, and had been passed as bioequivalent to what was used previously. They are looking at batch histories to see if there is anything there, but it doesn't look like it.
2) ICP data hasn't been analyzed yet--it will be part of the larger dataset to be done by the beginning of February. Since the FDA had made it clear that ICP would not be acceptable as a surrogate marker, they focused on anything they thought might be defined as clearly relevant by the FDA.

Their conclusion at the moment seems to be: We thought we understood TBI, we thought our animal models were accurate enough: it looks like neither is the case.

Harry
NeuroInvestment
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