So we now have confirmation of a path forward for
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Posted On: 05/01/2019 9:50:49 AM
So we now have confirmation of a path forward for PIII from FDA and are pursuing the same from the EMA. I found a list of things that typically happen for an end of PII meeting with FDA:
◾Develop the End of Phase II briefing package to be sent to FDA in advance of the meeting
◾Request/schedule the End of Phase II meeting
◾Determine meeting objectives and agenda, and script the participants
◾Conduct a meeting rehearsal
◾Attend the meeting and summarize results in formal notes
Next would be the EMA concurrence with a PIII path forward and then set the wheels in motion. To me, the fact that FDA agrees that a PIII trial is warranted based upon the data to date is a significant step here.
Stop and think about this......IPIX has a Phase III ready drug (with FDA concurrence) for an indication that currently has no SOC.
◾Develop the End of Phase II briefing package to be sent to FDA in advance of the meeting
◾Request/schedule the End of Phase II meeting
◾Determine meeting objectives and agenda, and script the participants
◾Conduct a meeting rehearsal
◾Attend the meeting and summarize results in formal notes
Next would be the EMA concurrence with a PIII path forward and then set the wheels in motion. To me, the fact that FDA agrees that a PIII trial is warranted based upon the data to date is a significant step here.
Stop and think about this......IPIX has a Phase III ready drug (with FDA concurrence) for an indication that currently has no SOC.
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