an RTF letter, which would definitely require disclosure by RVNC
I posted something similar either here or the bv board. However you would think the converse would also be true that acceptance of the sBLA constitutes a material event. However I don't think I have seen an RTF on an sBLA/NDA (at least for any of the companies I followed over the years), so the baseline expectation of acceptance might make such disclosure not particularly material and they can sit on an acceptance longer before issuing a PR about it