Hopefully some of our excellent contributors can help with this.
Fast forward 3 years and NNZ 2591 gets FDA approval for 2-3 of the current conditions, with 1-2 trials in P3.
Are we obliged to run safety trials every time we trial in a new condition or is there a real possibility that safety has been established and we can go straight to a P3/Registration trial?
Does that happen?
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