Registrational Trial definition
Registrational Trial means, with respect to a given Product, either: (a) a Phase III Clinical Trial with such Product; or (b) a Phase IIb Clinical Trial that, at the time of commencement, is expected to be the basis for initial Regulatory Approval of such Product.
Registrational Trial means a clinical trial of a Company Product that satisfies either of the following ((a) or (b)):
Registrational Trial means, with respect to a given Product, either (i) a Phase III Clinical Trial with such Product or (ii) a Phase IIb Clinical Trial that, at the time of commencement, is expected to be the basis for initial Regulatory Approval of such Product.
Examples of Registrational Trial in a sentence
If the Milestone Event for Initiation of a Phase 2 Trial for a Licensed Product set forth in Section 7.3.1(a) or Section 7.3.1(b) has failed to be achieved and BMS (or any of its Affiliates or Sublicensees) achieves the Initiation of a Registrational Trial, then such Milestone Event shall be deemed achieved and BMS shall pay to Avidity the Milestone Payment corresponding to Initiation of the Phase 2 Trial for a Licensed Product set forth in Section 7.3.1(a) or Section 7.3.1(b), as applicable.
More Definitions of Registrational Trial
Registrational Trial means either:
Registrational Trial means: (a) any Clinical Trial that is intended by Licensor, its Affiliate, or a Subsequent Licensee to be submitted for Regulatory Approval in the Territory; or (b) any Clinical Trial based on an agreement or other statement or guidance from the Regulatory Authority in such country that such Clinical Trial is designed to provide data on which a Regulatory Approval will be principally based.
Registrational Trial means any (a) a Phase 3 Clinical Trial, or (b) other Clinical Trial (or arm thereof) of a pharmaceutical or biologic product, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additional Clinical Trial, to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of the active substance of such product established by a Regulatory Authority in any particular jurisdiction and is intended to support, or otherwise supports, the filing of an MAA in such jurisdiction (including any bridging study meeting the foregoing requirements).
Registrational Trial means a Clinical Trial of a Licensed Product that is designed (at the time the Clinical Trial is Initiated) to obtain (as reasonably determined by BMS) results and data sufficient to support the filing of a Drug Approval Application and identified by BMS as a pivotal registration study in its development plans.
Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals). A Registrational Trial includes any Clinical Trial that satisfies at least one of the following criteria:
Registrational Trial means, with respect to a product, a human clinical trial (regardless of whether such clinical trial is referred to as a “Phase II Clinical Trial”, “Phase IIb Clinical Trial”, “Phase II/III Clinical Trial”, “Phase IIb/III Clinical Trial” or “Phase III Clinical Trial”) for such product, the results of which, together with prior information concerning such product, are determined by the sponsor to be intended to be sufficient to establish that such product is safe and effective for its intended Indication to support the filing of an MAA. [***]
Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals). A Registrational Trial includes any Clinical Trial that satisfies at least one of the following criteria:
(a) It would, based on interactions with a Regulatory Authority or otherwise prior to the initiation of such trial, satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations;
(b) It is designed in a manner to allow for the addition of patients such that it could satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations; or
(c) It is otherwise intended, at the time of initiation to support (either alone or together with another Clinical Trial that would satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations) an application for Regulatory Approval of a new product (or a new indication or intended use for an already approved product).