Cytodyn Inc (CYDY)

[Bill_ENG]

Looks like Nader zigged when he should have zagged.

It doesn't mean LL did not meet standards, means the FDA changed the standard.

Where Nader fails, he should have had the brain Metastases BTD ready to go and submit. What excuse can the FDA give ? What's the SOC there ?

Then while waiting on Brain Mets , prepare MTNBC and resubmit again. Bombard the FDA with results while keeping Brazil trials alive and progressing. The Brazil trials are set up and enrolling very slow and Brazil cases will rise and enrollment will pick up.

This is extremely important, Nader needs to let the Brazil trials fully enroll and not monkey with additional numbers because he can get the enrollment numbers needed in a surge without poisoning the trial data with non trial data.

In my opinion the FDA is allowing non trial data so that when Cytodyn does submit they can be picky and disallow data...that eats up time and gives the FDA plausible deniability.

Nader and his impatience and love of the shortcut will fall into this trap over and over.

The time eating process of setting up the trials , CRO , et all, are done in Brazil, cases are rising and will continue. He needs to not interfere in the process.

He needs to establish foreign markets and enough countries will follow ANVISA that will allow Cytodyn to survive, thrive prove it's power, then he can deal with the FDA from a position of strength with irrefutable data

Jmo