Just taking a guess on this but its possible the FDA needs clarification on m/m regarding protocol and profile of the patients who would receive the shot(s) vs who wouldnt. Will it be based on a NEWS2 profile ? and if so , how many categories need to show a problem? one ? two ? or? there isnt enough leronlimab to give everyone a shot who is infected obviously so there may be some back and forth between the FDA and Cytodyn for clarity, if its not already in the submission