easiest answer, watch R & D Day video (below) from you tube in addition to listening to the 51 capital audio interview with paul rennie (link below)... long story short... meticulous planning, adding additional value, and extra efforts to ensure covid doesn't impact phase three.... and possibly some requirements from FDA also..
https://open.spotify.com/episode/4YU9bcK4kNHLh3O3Jh18lF
We just submitted an IND - So now what?, page-17
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