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Post# of 426864
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Biobillionair

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Biobillionair

Re: Biobillionair post# 22285

Saturday, 11/30/2013 10:23:16 AM

Saturday, November 30, 2013 10:23:16 AM

Post# of 426864
This is an example of an expanded label "supplement approval" letter, it goes into detail about the changes. Amarin's "supplement approval" letter is very vague and refers 9-19 sNDA. More than one governmental agency designed this letter.

The example:

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022128s002ltr.pdf

-----------------
Peace out..... this could be very good or could mean nothing...only those with 9-19 sNDA knowledge know what's up.
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