What is the main purpose of an end-of-Phase 2 meeting between the IND sponsor and the FDA?

The main purpose of an end-of-Phase 2 meeting between the IND sponsor and the FDA is to evaluate the pivotal study design. This meeting typically occurs after the completion of Phase 2 clinical trials, where the sponsor presents the data collected thus far. The FDA provides guidance on the design of the upcoming Phase 3 trials, including considerations for endpoints, sample sizes, and overall study design to ensure that it adequately addresses regulatory requirements and provides sufficient evidence for efficacy and safety.

In this context, evaluating the pivotal study design is crucial because Phase 3 trials are intended to confirm the effectiveness of the drug and further assess its safety in a larger population. Hence, receiving feedback at this stage helps to increase the likelihood of a successful submission for approval.

The other options, while relevant to different aspects of drug development and regulatory processes, do not capture the primary focus of the end-of-Phase 2 meeting, which is centered around the design of pivotal studies leading into Phase 3. Product distribution channels, finalizing the product label, and setting timelines for clinical trials are important considerations, but they do not represent the core objective of this specific meeting.