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prophet_of_profit

07/16/07 4:08 PM

#75 RE: genisi #74

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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genisi

10/02/07 6:20 PM

#117 RE: genisi #74

Here is the direct link (better because Yahoo links sometimes magically expire).
http://www.sec.gov/Archives/edgar/data/1006281/000089109207001770/e27195ex99_2.htm
[c/o DewDiligence]