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Alias Born 05/28/2007

Re: genisi post# 74

Monday, 07/16/2007 4:08:26 PM

Monday, July 16, 2007 4:08:26 PM

Post# of 4054
Can you explain the "phase 3" slide?

QUOTE
======================================
Multi-center world wide study: efficacy
and safety in untreated patients with
significant symptoms of Gaucher Disease.

Protocol outline reviewed by FDA:
randomized, double blind, parallel groups,
dose-ranging study.

Measurable efficacy end point.
======================================

I could only see the half-life measurement in their p-1 study (no p-value, though). Is T/2 considered as EFFICACY end-point?

If not, what is the end point of the P-3 trial?


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