Replies to post #122522 on 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 ..

[Saltz]

If Nader says by end of year, it will fall into Spring 2021 as Rabbit said. To me it’s just mind boggling that the most important goal has been kicked to the curb. The focus is on S/C trial interim, enrollment, and most probably completion of trial.

We are staring at a fork in the road. Either we succeed w the S/C trial or we don’t. This is feast or famine. I’m fully aware of our countless potential indications however getting to trial results will be dependent on the S/C outcome.

Either future $ will be a very taxing situation that will handcuff progress or we will be the darling in the Covid therapeutic space w many options.

It’s really a very simple binary predicament for CYDY and SH’s. Could be a walk off home run or a strike out.