Cytodyn Inc (CYDY)

[misiu143]

Latane , - I have only one question here ..

With 350 mg of Leronlimab our efficacy is 81%
Compare to approved
45% with Maraviroc
And 43% Ibalizumab ..

Why FDA told us February 2019 they want us to go to 700 mg , and we will need only safety profile of 50 patients for 24 weeks ,
And now they want not only entire over 500 patients in our monotherapy , patients with 350 , 525 and 700 mg dose .but now they want both .safety and efficacy profile ,
and now also occupancy test for patients who will be only on one dose , 700 mg ..

And Receptor Occupancy Test all together was introduced sometimes about June-July 2019...

At this point I will just go back to FDA and insist to approve us with 350 and we will play with different dose later .,

All imo as always ..