Cytodyn Inc (CYDY)

[misiu143]

That is exactly right C-20

We finished our combo pivotal study in HIV , in February of 2018 , with 81% efficacy and not one serious side effect. So why was that not enough for FDA approval ????
FDA never questioned the 81% number..after they evaluate the study they said , you probably will do even better with 525 and 700 mg..

Why we needed to do better ??

The other 2 drugs approved for this group of patients ..

--Maraviroc with severe side effects , black box warning for liver injury , and 45% efficacy ..
--Ibalizumab , IV treatment every 2 weeks with 43% efficacy , and some serious side effects..

So why not..???
Well , I have my theory why not..

Gilead study for the same group of patients , capcid inhibitor was only in phase one.
FDA needed to slow us down , so they requested at this time 24 weeks long studies with 525 and 700 mg..

By now Gilead applied already for approval of their capcid inhibitor..

Yes , that what is happening..

And all this is IMO only..



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