Cytodyn Inc (CYDY)

[Bill_ENG]

CD16 and CD17 being required by the FDA for an EUA in the US are not affected by the drug being sold or given an EUA in another Country

If the FDA will not give EUA without a Trial passed without a requisite p-value then that is what the company needs to do

A phase 4 confirmatory trial is usually required by the FDA when a drug is given accelerated approval but has followed all processes including Phase 1, 2 and 3 and submitted a BLA The fact that some factors may not have been measured or tested more thoroughly is what causes that to be required.

The drug gets approved and goes commercial but trends are monitored and the approval can get recinded.

The drug being purchased by another Country or multiple Countries has no bearing on an FDA EUA.

All that will happen if existing LL is bought up, Is that the company gets revenue and gets more financially stable , they would get more consideration in partnership talks with a BP and could get new trials done .

No matter what happens, Cytodyn will have to complete new trials