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The Holder

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The Holder

Re: FSU1UF2 post# 10654

Sunday, 03/01/2009 7:12:26 PM

Sunday, March 01, 2009 7:12:26 PM

Post# of 58465
I think this is the appeal you're looking for.

http://www.medicalnewstoday.com/articles/133015.php

The PR is dated December 15th, 2008. I don't think anyone is exactly clear on when the appeal was officially submitted. Genta was to meet, formally, with FDA leadership to understand the issues associated with the NDA (reason(s) for non-approval) and address those issues prior to submitting the appeal.

I think the appeal was probably submited late January, early February.
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