REGISTRATION PACKAGE

REGISTRATION PACKAGE. Shall mean: (a) The standard dossier for a NDA for oncology products, the Table of Contents summary of which is attached as EXHIBIT D for illustrative purposes; and (b) As supplemented by data generated from the studies specified by the FDA during Xenova's meeting with the FDA on 25 April, 2001 (and summarized at the end of EXHIBIT D), unless the FDA later determines that any of the studies specified by the FDA during this meeting are ... not required. View More