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Biotech / Medical : Pharmos (PARS)
PARS 2.700+13.6%Jan 21 4:00 PM EST
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To: NeuroInvestment who wrote (972)1/25/2000 10:04:00 AM
From: Rick Strange  Read Replies (1) of 1386
 
NeuroInvestment,
Does the UCSC study (Marshal et al), showing ICP as the prime predictor of morbidity and outcome, increase the chance that the FDA will accept lowered ICP as the primary end-point for HU-211. How would this affect the trial design (size, duration and follow up)?

Would HU-211 be a candidate for approval, considering TBI has a high morbidity rate and there is no available drug to treat the condition, for approval sans Phase III allowed under the FDA reform rules?
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