Phase 2b Clinical Trial definition

Phase 2b Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial of the feasibility, safety, dose ranging and efficacy of such product, that is prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Clinical Trial (or foreign equivalent) of such product, as further defined in 21 C.F.R. 312.21(b) or the corresponding regulation in jurisdictions other than the United States. A Phase 2B Clinical Trial shall be deemed initiated upon the dosing of the first patient.

Phase 2b Clinical Trial means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to make a preliminary or qualitative determination of efficacy of a Product in the patients being studied for the dosage regimes indicated in the related Phase 2a Clinical Trial as required under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.

Phase 2b Clinical Trial means a Phase 2 Clinical Trial that is designed in such a way as to provide efficacy and safety information about a Licensed Product that would be reasonably intended to lead to an End-of-Phase 2 (EOP2) meeting with the FDA, or an equivalent meeting with any Regulatory Health Authority, or a subsequent Phase 3 Clinical Trial, even if such EOP2 meeting or Phase 3 Clinical Trial does not occur.

Examples of Phase 2b Clinical Trial in a sentence

• Through March 31, 2019, the Company has received $12.5 million of the 2018 CFF Award and the Company expects the remainder of the 2018 CFF Award will be paid to the Company incrementally upon the achievement of the remaining milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement.

• The Company expects the final $2.5 million remainder of the 2018 CFF Award will be paid to the Company upon the achievement of the last remaining milestone related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement.

• Through June 30, 2019, the Company has received $17.5 million of the 2018 CFF Award and the Company expects the remainder of the 2018 CFF Award will be paid to the Company incrementally upon the achievement of the remaining milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement.

• We Believe the Board Has Deflected Accountability and Has Regularly Shifted Timelines and Missed Milestones With Respect to the Lifting of the Clinical Hold on its Phase 2b Clinical Trial The Company submitted its Investigational New Drug (IND) Application with respect to the use of its Cell-in-a-Box® platform in locally advanced, inoperable pancreatic cancer ("LAPC") almost two years ago in September 2020.

More Definitions of Phase 2b Clinical Trial

Phase 2b Clinical Trial means, with respect to the United States, a clinical trial of a product, designed to support and precede the Initiation of a Phase 3 Clinical Trial program, on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such product in the target patient population over a range of doses and dose regimens, as described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, an equivalent clinical trial.

Phase 2b Clinical Trial means a study of a Licensed Product in the Field in human patients to determine initial efficacy, pharmacological effect, or dose range and/or regimen finding before embarking on Phase 3 Clinical Trial, as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding foreign regulations.

Phase 2b Clinical Trial means a Phase 2 Clinical Trial designed for the purpose of determining the safe and effective dose range prior to initiation of a Phase 3 Clinical Trial.

Phase 2b Clinical Trial means a human clinical trial performed in accordance with the Applicable Laws in patients with a particular disease or condition which is designed to assess the safety, dose ranging and efficacy of a pharmaceutical product to confirm clinical efficacy of a drug and determine the therapeutic dose range and may include such a clinical trial intended to be a Pivotal Trial. Any Phase 2 Clinical Trial of a Product in an indication that is the second Phase 2 Clinical Trial of such Product in such indication shall be deemed to be a Phase 2b Clinical Trial.

Phase 2b Clinical Trial means, as to a particular Licensed Product for an Indication, a Phase 2 Clinical Trial, or the relevant portion thereof, conducted in a sufficient number of patients to generate sufficient data, if successful, to either commence a Phase 3 Clinical Trial of such Licensed Compound for such Indication or file an NDA for such Licensed Product for such Indication.

Phase 2b Clinical Trial means a clinical trial generally consistent with 21 CFR §312.21(b) that is required for receipt of clearance or marketing authorization of a Licensed Product from the applicable Regulatory Authority and which is conducted to assess the optimal manner of use of such a Licensed Product (dose and dose regimens) for a particular indication or indications in patients with the disease or condition under study.

Phase 2b Clinical Trial means a study of a pharmaceutical product in human patients to determine efficacy and statistical trends prior to initiation of Phase 3 pivotal studies. These studies will also evaluate potential doses and dosing regimens to optimize the therapy under investigation.