The phase 3 study hit its primary endpoint and was

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The phase 3 study hit its primary endpoint and was statistically significant, so it should seem that the clinical phase of the study is complete. What is missing and why can't we get the BLA filed?
I've heard everything from dosage justification to RO data, to improper labeling of syringes.

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It wasn't the labeling of syringes the FDA said the manufacturer wasn't listed in the BLA but it was twice. The RO test was not accepted by the FDA which would be part of the basis for dose justification. There are workarounds to that. Yes the clinical phase of the study is complete but the BLA portion of it isn't. That part of the BLA has missing, incomplete and mis-structured data due to Amarex. When Cytodyn is able to access that data the new CRO will have to see if they can fix it.