Cytodyn Inc (CYDY)

[Bill_ENG]

You do understand that a rolling review is when a company is allowed to submit a BLA in its various sections as a company completes each section. This is instead of submitting the entire BLA at once.

People think that the FDA is reviewing each piece as it is received and accepting, but this is not necessarily the case, the FDA will not accept the BLA until after the whole thing has been submitted and it still takes a while to hear back about acceptance and then get a PDUFA date. After that point and after the BLA has been reviewed they can still get a CRL or an FDA approval.

jmo