How to Prepare for the End-of-Phase 2B Meeting with Regulatory Authorities

Introduction

The End-of-Phase 2B (EOP2B) meeting is a pivotal milestone in clinical drug development. It provides an opportunity for sponsors to align with regulatory agencies—particularly the U.S. FDA—on the adequacy of Phase 2 findings and the readiness to initiate a pivotal Phase 3 trial. The outcome of this meeting often determines whether a development program advances or needs reconfiguration. This tutorial walks through the key steps, documents, and strategies to prepare for a successful EOP2B meeting.

What Is the Purpose of the EOP2B Meeting?

• Evaluate safety and efficacy data from Phase 2
• Discuss dose selection and dosing regimen for Phase 3
• Align on trial design, endpoints, and statistical plan
• Resolve issues related to manufacturing and regulatory filings
• Gain feedback on the overall development plan and Target Product Profile (TPP)

When Should the EOP2B Meeting Be Requested?

• Typically after completing confirmatory dose-ranging Phase 2B study
• Ideally 3–6 months before launching Phase 3
• Request submitted as a formal meeting request to the FDA (Type B meeting)

Meeting Types and Response Timelines (FDA)

Meeting Type	Timeline	Response Time
Type B (EOP2)	Submit request 75 days before desired meeting date	FDA will respond in 14 days
Written responses only	Option if meeting not granted	Within 30 days of request

Key Documents to Prepare for the Meeting

1. Meeting Request Letter

• Specify the objective of the meeting
• Propose format (in-person, teleconference, or written response)
• Suggest preferred dates

2. Briefing Document

Must be submitted at least 1 month before the scheduled meeting. It includes:

• Background and development history
• Phase 2 study designs, results, and interpretation
• Proposed Phase 3 design and statistical plan
• Updated Investigator’s Brochure (IB)
• Specific questions for regulatory feedback

3. Module 2 & 5 Summaries (if requested)

• Summaries of clinical pharmacology, toxicology, and efficacy findings

4. TPP (Target Product Profile)

• Outlines intended use, population, dosing, route, safety profile, and efficacy claims

Questions Typically Addressed in EOP2B Meetings

• Is the proposed dose and schedule appropriate for Phase 3?
• Are the efficacy endpoints acceptable for regulatory approval?
• Is the safety database adequate to support future filing?
• Does the agency agree with the statistical powering assumptions?
• Are additional studies required before Phase 3?

Tips for a Successful EOP2B Meeting

• Engage cross-functional teams early (clinical, regulatory, CMC, biostatistics)
• Prepare clear, concise briefing materials with well-formulated questions
• Include backup slides to support complex issues (PK/PD, subgroup analyses)
• Anticipate regulatory concerns and prepare evidence-based responses
• Clarify roles for each team member during the meeting

EMA and Other Agencies

• EMA does not have a formal “EOP2B” meeting but offers Scientific Advice or Protocol Assistance
• PMDA (Japan) offers Pre-Phase 3 consultation meetings with specific submission packages
• CDSCO (India) requires protocol and safety review by Subject Expert Committees (SECs) prior to Phase 3

After the Meeting

• Submit a meeting summary with minutes and action points
• Revise your Phase 3 protocol or IND/CTA as per feedback
• Document all regulatory guidance decisions in the TMF
• Communicate outcomes with internal stakeholders and partners

Conclusion

The End-of-Phase 2B meeting is a strategic checkpoint that influences the entire late-stage development program. Sponsors who prepare thoroughly—with robust data, clear questions, and proactive risk mitigation strategies—can leverage this meeting to de-risk Phase 3 trials, align globally, and accelerate time to approval. Treat it as more than a regulatory meeting—view it as your opportunity to solidify development strategy with agency collaboration.