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Biotech / Medical : Novoste (novt)
NOVT 128.97-1.5%3:59 PM EST
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To: Zantac who wrote (50)3/13/1999 8:48:00 PM
From: Todd Hubbard  Read Replies (3) of 100
 
The question is why the study needed to be more highly powered with the additional 300 patients. Wasn't the original study only for 1000 patients in the first place? To increase the number of patients by a third suggests that the clinical differences were not as great as those seen in the Phase II studies or that a large portion of the early patients were excluded. I also wondered about the recommendation for longer anti-platlet treatment (from 14 to 60 days). Does anyone know what the reported adverse events history has been?

Taken together, it makes me wonder if the Phase III trials have been going as well as the original Phase II studies -- we've all seen that before.
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