In regards to the blaming of the FDA to willfully delay the trials I have to say that:

-The stated efficacy in mono from our company, was past 10 weeks, but the protocol to my knowledge, did not state to messure the efficacy after 10 weeks

I know there have been solutions how to come by, with longer overlay etc., but I quess its normal that the FDA wants prove in trials for that as well

-For combo: here you have the same, 95% on 525mg was past 10 weeks;
If you go with that, that would mean as well that for some patients (the one with vl failures in the first weeks) our medicine wouldnt work out

So for me it would be understandable, if the FDA says we want to make sure that as much people as possible can get treated with leronlimab, and they know we have the recepter occupancy test and we can figure out which dose suits best

I read here all the time the high efficacy, but people forget it was past 10 weeks, which doesnt count, and thats the reason for the new P3 mono as far as I understand

Despite that, Im sure we will have same or even higher efficacy right from the start when we use the receptor test.