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DewDiligence

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DewDiligence

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Re: DewDiligence post# 213941

Thursday, 09/28/2017 5:31:08 PM

Thursday, September 28, 2017 5:31:08 PM

Post# of 257266
CHRS/MNTA—Addendum re Humira-FoB settlement:

Unlike MNTA, CHRS acknowledges that the existing formulation of its Humira FOB infringes ABBV's US patents. CHRS is therefore developing a new Humira-FoB formulation and will submit its 351(k) application when the reformulation work is done.

How will the FDA handle a 351(k) application where the phase-3 data pertain to a different formulation? I don't know. As a MNTA (but not a CHRS) shareholder, I'm glad I don't have this concern.

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

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