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genisi

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genisi

Re: ghmm post# 143161

Tuesday, 06/05/2012 3:54:56 AM

Tuesday, June 05, 2012 3:54:56 AM

Post# of 253527

It seems there are some concerns about the results and what they have to show for approval.

I haven't heard the call either but think I found the problem after looking at the two tables here:

http://services.corporate-ir.net/SEC.Enhanced/SecCapsule.aspx?c=142125&fid=8226167

Efficacy Results came from 612 patients while Most Common Adverse Events data came from 832 patients, meaning efficacy analysis wasn't done on ITT population. No idea if the FDA will accept their analysis.
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