Replies to post #75992 on Cytodyn Inc (CYDY)

[Pctwst]

So the BLA has been submitted it just needs a data set update at the request of FDA to be considered complete? Is that the correct interpretation?

[Borel Fields]

Thanks for highlighting this OUTSTANDING news from the FDA.

It says they have finished their first look at the filing (which was made when stated), and that all they need are a few database adjustments, expected in under a week, after which it will be considered not only FILED, but COMPLETE!

The FDA could have (and often does) say a filing is inadequate and ask for more studies.

With the promised PDUFA, they should give us a DATE for an advisory meeting and for APPROVAL.

Again, thanks for highlighting the OUTSTANDING news.