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11/06/15 7:04 AM

#170688 RE: Jimmy Joe #170683

Camargo is the specialist and we will all know later the regulatory pathway chosen.

http://www.camargopharma.com/what-is-505b2.aspx


http://regprofessional.com/resources/505(b)(2).pdf

Embeda was approved by the 505(b) pathway

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022321Orig1s016ltr.pdf