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