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labner

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labner

Re: Biobillionair post# 22078

Friday, 11/22/2013 6:35:58 PM

Friday, November 22, 2013 6:35:58 PM

Post# of 426875
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Please look at this, it may help you tremendously in your efforts.

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000AdminCorres.pdf

Wasn't it you that mentioned the switch on 505 (1). If so, you will find e-mails on that issue in the link. also, discussions on NCE from Chowdbury and Coleman, prior to nda acceptance of nda for marine.

Also, find more documentations (hidden deep in the FDA archives)on clinical reviews, statistical reviews, and other related issues by highlighting and right-click the below (both lines) :

APPLICATION NUMBER:
202057Orig1s000
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