A better way of understanding protocol changes wit

A better way of understanding protocol changes with the FDA would be to parse out an FDA approval to proceed with the study from subsequent amendments to protocol, which are not uncommon and often pretty minor; the FDA portal for protocol submission is versioning each and every change introduced by the sponsor. I would regard the inclusion and exclusion criteria along with Leronlimab treatment protocol as pivotal to have been under deep scrutiny to get to final approval by the FDA. The oncologist however is going to react to the clinical picture which emerges and if there surfaces an opening to add a PD-L1 inhibitor based on lab results they are probably not going to hesitate to do so unless it was specifically called out as an exclusion in the study. I suspect this would be considered a more minor change to the protocol and it would simply be adjusted by the study sponsor on the FDA portal with no subsequent objection by the FDA. The key thing is that Cytodyn added the lab to the study so that analysis of subgroups that might include PD-L1+ patients treated with Leronlimab and a PD-L1 blocker added in response to lab data can be scrutinized further as far as outcomes. Remember this is a phase 2 “exploratory” trial which is not just probing impact on defined primary and secondary endpoints but trying to lend additional credence to clinical impact by fleshing out the details related to purported mechanism of action.