Why a trial?, page-42

Got remember also that if we had have done a trial, maybe the fda wouldnt have look at those results as they said we couldnt start a trial until the potency assays had been improved, which now seems to be the case.
I note in the CC from Friday Si says this " we have received substantial clarity in how to bring this product to much needed patients", he then goes onto talk about a small very targeted trial in adults, and he seek alignment with the fda on trial design at the type A meeting.
I ask ok what is the substantial clarity the fda have given you on how to bring this product to much needed patients. I note the word substantial.