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DewDiligence

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DewDiligence

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Re: genisi post# 71486

Wednesday, 01/14/2009 9:45:36 PM

Wednesday, January 14, 2009 9:45:36 PM

Post# of 257628
SGP – Asenapine approval sounds like a fait accompli inasmuch as the FDA does not put proposed labeling in a CRL if there are consequential issues outstanding.

http://finance.yahoo.com/news/US-FDA-Issues-Complete-prnews-14055997.html

The action letter includes proposed labeling for both indications and a request for supplemental data from the existing asenapine database.

This appears to be yet another licensing screw-up by PFE.


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