Cytodyn Inc (CYDY)

[Bill_ENG]

You are correct .

It is much better to take an extra three months or even more to ensure the BLA is submitted correctly.

Seems like NPs newest addition either spotted some weakness or at the least, advised Cytodyn on being more precise and bringing in someone to vet the clinical portion before submission.

When you get one chance to hit the bullseye every 1 1/2 years you have to make the shot count.

Getting someone who has actual experience submitting each module is the best chance of approval. Those modules will each require different experts.

The FDA BLA rejection rate has gone over 50% since the Alzheimer's debacle, it used to be below 20% . Another point, it actually might be better to wait till FDA leadership is solidified before submitting.

Having good or better than good results in Brazil would change the perception of Cytodyn as a " easy to kill upstart".

Jmo