Not a big fan of the FDA but the BLA issues were self induced . 4 out of 5 BLAs are approved; ours wasn't. and it wasn't because of any FDA bias. If the BLA didnt have so many flaws , LL would be in the market today as an HIV drug. The CRO blew it and management didn't manage the CRO. We were always assured that the Cytodyn team wasn't stretched too thin back then but it turns out that probably wasnt the case.