Phase II Study Initiation means the first human clinical trial conducted in patients and designed to indicate a statistically significant level of efficacy for product in the desired indication, as well as to obtain some indication of the dosage regimen required; provided, however, with respect to oncology, "Phase II Study Initiation" means the first human clinical trial conducted on a series of patients with the same type and stage of cancer.
Phase II Study Initiation means the first dose administered to the first patient in the first human clinical trial, whether in the United States or outside the United States, intended for submission to the FDA, or the applicable foreign Governmental Authority empowered to grant Regulatory Approval of a BLA, and designed to indicate a statistically significant level of efficacy for or a biomarker therefor for a product in the desired Indication, as well as to obtain some indication of the dosage regimen required.
Phase II Study Initiation means the dosing of the first subject in the first human clinical trial, whether conducted in subjects in the United States or outside the United States, that falls within the definition of a “Phase 2” study in Section 312.21(b) of Title 21 of the U.S. Code of Federal Regulations, as amended from time to time, or the equivalent in any foreign country, and that is a controlled clinical study conducted to evaluate the effectiveness of the subject drug for the desired Indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
Examples of Phase II Study Initiation in a sentence
Phase II Study Initiation [***] Phase III Study Initiation [***] Regulatory Approval in US [***] Regulatory Approval in any of France, Germany, Italy, Spain or the UK [***] Each development event payment shall be paid only once the first time the first Product reaches the applicable Development event, regardless of the number of times such events are reached by the same or another Product.
More Definitions of Phase II Study Initiation
Phase II Study Initiation means the first human clinical trial conducted in patients and designed to indicate a statistically significant level of efficacy for product in the desired indication, as well as to obtain some indication of the dosage regimen required; provided, however, with respect to oncology, “Phase II Study Initiation” means the first human clinical trial conducted on a series of patients with the same type and stage of cancer.
Phase II Study Initiation means the first human clinical trial conducted in patients and designed to indicate a statistically significant level of efficacy for product in the desired indication, as well as to obtain some indication of the dosage regimen required.