To travel to Kano, Pfizer needed the U.S. Food and Drug Administration's (FDA) authorization to export Trovan. On 15 March 1996, Pfizer informed the FDA of its intent to conduct the Kano study. (Compl. P 108.) Thereafter, Pfizer obtained a 20 March letter from the Nigerian government and a 28 March letter from IDH's ethics committee permitting Pfizer to export Trovan to Kano. (Compl. P 108.) Although both letters predate Pfizer's departure for Kano, plaintiffs allege that no IDH ethics committee existed as of 28 March 1996 and that the 28 March letter was back-dated in response to a 1997 FDA audit. (Compl. PP 132-33.) Pfizer,