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DewDiligence

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DewDiligence

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Re: genisi post# 150838

Tuesday, 11/27/2012 8:53:26 AM

Tuesday, November 27, 2012 8:53:26 AM

Post# of 252449
What is GIVN referring to in this paragraph on the COLON 2 application?

http://finance.yahoo.com/news/given-imaging-submits-pillcam-r-060000245.html

Based on guidance provided by the FDA, Given Imaging has submitted its PillCam COLON 2 application through a direct de novo pathway. Under new guidelines specified by the FDA Safety and Innovation Act (FDASIA) of 2012, the Company believes that the direct de novo pathway may expedite the regulatory approval process by a few months.

Emphasis added.

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

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