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Biotech / Medical : Pharmos (PARS)

PARS 2.700

+13.6%

Jan 21 4:00 PM EST

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To: gfp927z who wrote (1333)	12/2/2004 12:19:18 PM
From: Clarksterh	of 1386

If the Phase 3 results are equally compelling (of course that's always the big "if"), how could the FDA not approve such a drug, considering the current lack of treatments, and the drug's excellent safety profile? Wouldn't a 6 month 45% GOS improvement favoring Dex over placebo easily be sufficient for approval? Well, that is a simple question: The FDA would have to approve it as long as there are no irregularities. More stringent CT criteria in the Phase 3 to confirm frontal lobe trauma. I believe this to be true, but I have never seen a thorough discussion/confirmation of it and don't yet know enough about the terms used. Did you run across such a discussion/confirmation? I think that this is likely to be an important point - even the GCS 7 and 8 patients in the Phase III are actually sicker than the GCS patients in the Phase II. Clark

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