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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: tom pope who wrote (10334)2/7/2004 11:01:41 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
Are two arm studies the norm in Phase II's?

My guess is a healthy majority of Phase II's nowadays have a control arm. A lot also have multiple drug arms, with varying doses.

Proceeding to a Phase III without first running a controlled Phase II is fairly dangerous - that's what PCYC did - they showed good efficacy when compared with a historical database (case control) but then flamed out in the Phase III.

But clearly running a small controlled Phase II is dangerous - chances are you won't show statistical significance and your stock will tank despite your cries that the study wasn't powered to show significance.

Peter