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Biotech / Medical : Pharmos (PARS)
PARS 2.700+13.6%Jan 21 4:00 PM EST
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To: Ron who wrote (1132)4/13/2000 7:46:00 PM
From: NeuroInvestment  Read Replies (1) of 1386
 
The FDA accurately reasons that hospitals/practitioners will ultimately buy and use HU211 on the basis of believing that it will improve patient outcome. So they want Pharmos to prove that such is actually the case, rather than using a surrogate endpoint. I am not defending the FDA, I personally believe that the connection between ICP and clinical outcome is pretty clear, and the fact that ICP is so much more easily measured than vaguely defined 'clinical outcome' makes it a much simpler trial to run. But that's the CNS Division of the FDA for you. They will never let little things like patient care stand in the way of scientific rigor. NeuroInvestment (www.neuroinvestment.com)
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