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Biotech / Medical : Biotech Valuation
CRSP 53.33-0.4%Nov 26 3:59 PM EST

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To: Mike McFarland who wrote (1101)5/18/2000 10:32:00 AM
From: RWReeves  Read Replies (2) of 52153
 
Mike, Phase I is mainly a safety trial. You are not looking for efficacy and try for reasonably healthy (i.e. definitely not late stage)patients. Generally the biostatistics are not in place in a PI to allow assessment of response to treatment for anything short of a huge effect and even then it generally only leads directly to PII/III rather than use for approval.

Most trials in all Phases try to treat the least seriously ill patients possible so as to reduce the confusion of "normal" disease progression and adverse events resulting from the treatment. This is never simple.

RWR
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