Replies to post #159726 on Cytodyn Inc (CYDY)

[LifeLongLearner]

Just to add to B52T38’s question, it was my understanding that other countries don’t require RO for approval.

Is that true?

[misiu143]

B52T38 , I hope you don't mind that I will try to answer your question for today..

Receptor Occupancy Test will be very important for combo if we be using with patients all 3 doses of Leronlimab , 350 mg , 525 mg and 700 mg.

We know now that density of CCR5 is different in every patients , so some patients may need different dose ..


The problem with this request for combo is that FDA told us , probably over a year ago they want us to use only 700 mg dose for combo patients..

With this information I don't know why months ago they added ROT as a part of BLA. This test will not help if we already on the highest dose.
Yes some patients maybe ok with lower dose , but FDA want to approve , they said 700 mg.

So who knows what they really want...Maybe now they want to approve all doses depending on density test , actually this will be a proper medicine , but why to add 3 years after study finished.
They should approve now with 700 mg or 350 mg , efficacy was 81% , and then work on ROT , but no..

All IMO.