Yeah it's blown all my timetables too...not just FDA but also TGA.
I could come up with a few reasons as to why it's late but I'd just guessing...can't do anything about it.
When we last put in our IND it was 7 long months. We are Fast Tracked now so theoretically it shouldn't be quite that long! Also back then it was Covid...
- Mozz
PAR. SP, page-1065
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