As per the above graphic showing the EOP2 meeting protocol set out by the FDA
- Neuren would already have submitted a written request letter for EOP2
- Within 14 days of that , the sponsor (Neuren) would be notified in writing that the EOP2 meeting has been granted by FDA
- Neuren would then have 20 days to submit their EOP2 package to FDA (50 days prior to meeting)
- Within 70 days of the meeting being granted by FDA - the EOP2 meeting takes place
- FDA releases official minutes of the EOP2 meeting within 30 days post meeting
Going by this timeline I'm assuming Neuren has submitted their EOP2 package (trial data etc. etc.) & know that the meeting will take place within 50 days & that date falls within September 2024 as they have advised.
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- End of Phase 2 Meeting with FDA - September 2024
As per the above graphic showing the EOP2 meeting protocol set...
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