Phase 2a Trial definition
Examples of Phase 2a Trial in a sentence
As used herein, “completion of the first Phase 2a Trial in the U.S.” means the completion of all patient dosing for such Phase 2a Trial and the preparation and submission to BMS by Elixir of the preliminary clinical studies report plus the clinical data and tables for such trial.
Such Phase 2a Trial shall have been designed to show statistically powered dose-dependent efficacy as the primary endpoint, as described in Appendix 3.
Promptly after completion of the Ongoing Phase 2a Trial (as defined on Attachment A), METHODIST will or will cause to be delivered to LICENSEE a copy of all documentation and data generated for or from the Ongoing Phase 2a Trial.
In this regard, it is the intent of the parties that at least the initial Clinical Trials will be performed with a DMI-7958-Product which is the same as, or equivalent to, a DMI-7958-Product that has already received Regulatory Approval for uses outside the Field, so that Preclinical Studies and Phase 1 Trials need not be performed, and a Phase 2a Trial of such a DMI-9758-Product can be commenced as soon as practicable after the Effective Date.
DMI and ENHANCE entered into a Letter Of Intent, effective as of January 29, 2003, setting forth terms and conditions whereby the necessary steps can be taken so that a Phase 2a Trial of a DMI-7958-Product can be commenced by March 2003 or as soon as possible thereafter.