In regards to needing to get more data to comply w

In regards to needing to get more data to comply with any concerns the fda(or other regulatory entity) might have, it shouldn't be a scramble to obtain due to the fact that "all cause mortality at day xx" (be it day 30 or 42 or 60, etc) would fall under the catagory of SAE which are reported to the sponsor and the fda as they occur. The only difference being the data is unblinded now which can be compared/correlated to either treatment or control arm of the study.