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DewDiligence

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DewDiligence

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Re: DewDiligence post# 93667

Thursday, 07/24/2014 5:53:59 PM

Thursday, July 24, 2014 5:53:59 PM

Post# of 257253
FDA accepts for review NVS’ 351(k) Neupogen-FoB submission:

http://www.novartis.com/newsroom/media-releases/en/2014/1835571.shtml

This is the first 351(k) submission ever accepted by the FDA.

351(k) is the designation for the FoB-approval pathway established in 2010 as part of the ObamaCare legislation (#msg-48581353).

NVS’ Neupogen FoB is already marketed in more than 40 countries under the brand name, Zarzio.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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