Replies to post #38076 on Cytodyn Inc (CYDY)

[Bored Lawyer]

This was my understanding as well.

CYDY previously announced that the FDA would permit rolling submission. In other words, CYDY could submit the BLA in pieces, but the FDA would only review the BLA once CYDY submitted the full BLA.

I take this morning's PR to mean that the FDA has, in addition to permitting rolling submission, told CYDY that it will review portions of the BLA as it is submitted.

If correct, this is obviously helpful to CYDY, because it should shorten the overall time to approval.