Just a question about FDA time requirement for the p3 trials .
Is there a time requirement for the FDA to respond to PAR submission for the p3 trials ?
I think it was mooted some time ago as being a 3 month period after submission by PAR
The PAR submission was 19 May I think so that makes it approx 16 days short of the 3 months at present .
Any comments ?
FDA decision timeline for phase 3 trials
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