IMO application to an ACTIV trial would require a end of phase 2 meeting with the FDA.
End of Phase 2 (EOP2) Meetings What is the Purpose of the End of Phase 2 Meeting with the FDA
Following your Phase 2 clinical trials, you will need to review and obtain agreement from the FDA on your study designs for Phase 3. This is the purpose of the End of Phase 2 (EOP2) Meeting with FDA, in which you’ll need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
During this meeting, FDA will determine whether it’s safe to proceed to Phase 3. They will evaluate your Phase 3 plans and protocols along with your existing studies to assess effectiveness, and they’ll note if any additional information is necessary to support the marketing application. The End of Phase 2 Meeting is a critical milestone in your development program, so it’s important to prepare in order to make sure you leave with plenty of helpful feedback. Who is Eligible for an End of Phase 2 Meeting?
The EOP2 Meeting with the FDA is typically for Investigational New Drugs (INDs) which involve new molecular entities or major new uses of marketed drugs. However, a Sponsor of any IND may request an EOP2 Meeting with FDA in preparation for Phase 3. When Should the End of Phase 2 Meeting occur?
As the name implies, the EOP2 Meeting should occur at the end of Phase 2 clinical trials. Furthermore, the meeting should occur before serious resource commitments are made towards Phase 3. However, the EOP2 Meeting should not delay the transition from Phase 2 to Phase 3, which is why planning and preparation are critical. Preparation for End of Phase 2 Meeting
To move you to the next clinical trial phase, ProPharma Group will diligently work with you to prepare for the EOP2 Meeting. With your input, our experts will:
Develop the EOP2 briefing package to be sent to FDA in advance of the meeting Request the EOP2 Meeting Determine meeting objectives and agenda and script the participants Conduct a meeting rehearsal at our offices in Washington, DC Attend the meeting with you and summarize results in formal notes Conduct a debriefing session to discuss the accomplishment of meeting objectives and finalize meeting minutes to be sent to the FDA
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