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DewDiligence

05/22/12 12:58 PM

#142375 RE: DewDiligence #117585

FDA briefing docs blast PFE’s tafamidis for familial amyloid polyneuropathy:

http://in.reuters.com/article/2012/05/22/us-fda-pfizer-idINBRE84L0ON20120522

The FDA issued an RTF letter on this NDA in Apr 2011 (#msg-61705863) and PFE then resubmitted. Despite the troubles with the FDA, tafamidis is approved in the EU under the brand name, Vyndaqel. PFE acquired tafamidis in the 2010 deal for private company, FoldRx (#msg-53934948).

All told, this is not a needle-moving program for PFE under any circumstances.