definiens: means an Investigational New Drug application as defined in 21 C.F.R. 312 and any versions thereof governing the FDA as may be amende d from time to time . means, with respect to a Product, such Product ’s in terference with a gene to affect a specific primary endpoint of a pathophysiologic state, regar dless of etiology . For purposes of clarity, if an Indication was not included in a particular NDA ( or any foreign counterpart or equivalent section ) for a Product but is included in a subsequ ent NDA ( or abbreviated NDA or supplemental NDA ) for such Product, such Indication is presumptively a separate and distinct from all other Indications for such Pr oduct . means with respect to a clinical study, the initial dosing of the first pat ient in such study . means an Institutional Review Board as defined in 2 1 C.F.R. 56 as may be amended from time to time, or its applicable foreign equivalent