The FDA has 30 days to respond to IND submissions. The IND submission for Angelmans was 1st September. So, this coming Friday, 1st October, is 30 days. Assuming the response is positive, Neuren only then needs to await Ethics Committee approval to commence the trials in Australia in 3 hospitals. I have no feel for this timing, but would suggest it's probably in line with IND approval timelines.
Neuren stated on the 1st September that it is "preparing to commence the Phase 2 trial upon the approval of both applications". Assuming they have prepared well, could we be commencing a Phase 2 trial in Angelmans next week.....? Food for thought.
Ann: Angelman IND and Ethics applications submitted for NNZ-2591, page-8
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