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 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 either:
Examples of Registrational Trial in a sentence
Initiation Milestone Milestone Event Milestone Payment Initiation of a Registrational Trial for a Contingent Payment Product.
The recommendations in section III.C., Registrational Trial Considerations, apply to drug product development programs for GnRH analogues in advanced prostate cancer for all dosage forms and routes of administration (e.g., tablets, capsules, injectable suspensions, injectable emulsions, subcutaneous implants).
More Definitions of Registrational Trial
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.
Registrational Trial means a clinical trial of a Company Product that satisfies either of the following ((a) or (b)):
Registrational Trial means any (a) Phase 3 Clinical Trial, (b) Clinical Trial that is agreed and designated by a Regulatory Authority to be a pivotal trial or registrational trial sufficient to form the basis for submitting an application for Regulatory Approval of such Product, based on guidance or discussions with such Regulatory Authority; or (c) Clinical Trial subsequently determined to be the basis for submitting an application for Regulatory Approval of such Product.
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 human clinical trial of a compound or product in any country that (a) is a Phase III Clinical Trial or (b) is otherwise intended to provide sufficient efficacy and safety data to support the filing of an MAA that the applicable Regulatory Authority has agreed (as evidenced by definitive written correspondence, which may include meeting minutes, letters, email correspondence or other written correspondence) could serve as the basis for a Regulatory Approval (which may include an accelerated Regulatory Approval) even if such trial is a Phase I Clinical Trial or Phase II Clinical Trial.
Registrational Trial means a controlled study in humans (regardless of whether or not called a “Phase 3 Clinical Trial”) for a product the results of which, together with prior data and information concerning such product, are intended to be sufficient, without any additional Clinical Trial, to meet the evidentiary standard for demonstrating the safety and efficacy of such product established by a Regulatory Authority in any particular jurisdiction, and is intended to be sufficient for filing of a BLA (or similar application in a country outside the U.S.) for such product in patients having the disease or condition being studied.
Registrational Trial means a human Clinical Trial that satisfies at least one of the following criteria (regardless of whether such trial is referred to as a “phase 1 clinical trial”, a “phase 2 clinical trial”, a “phase 2b clinical trial” or a “phase 3 clinical trial”):