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DewDiligence

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DewDiligence

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Re: DewDiligence post# 193253

Wednesday, 07/08/2015 7:35:27 PM

Wednesday, July 08, 2015 7:35:27 PM

Post# of 257285
EGRX addendum—Evidently 505b2 applications without priority review still get a 10-month review (counting from the submission date, not from the FDA’s acceptance date). EGRX submitted the Bivalirudin NDA on 5/20/15 (#msg-113852714) and announced today (on the CF webcast) that the PDUFA date is 3/20/16.

(EGRX didn't PR the FDA's acceptance of the NDA, but they might do that tomorrow morning.)

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

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