Think of it this way. When a BLA is submitted it contains a LOT of information in a lot of specific formats. Amarex did such a poor job of compiling and reporting on the safety components of that information that three independent auditing groups said the BLA wouldn't be able to be approved. We know it's not Samsung, and we know it's not efficacy holding us back. It's incomplete, poorly done, or completely missing information that Amarex was supposed to have taken care of for all that money we paid them. The kinds of reports, databases, and results that one would want to sift through to look for any additional signals of adverse events should one or two questionable events pop up, which is exactly what happened. Now, instead of handing over your well executed and catalogued safety information you're handing them over a bag full of crumpled up receipts that Amarex handed over and the FDA is like, "This isn't how this works. You need to properly gather all the information you should have already had, and once we have that and it lines up with what you're telling us you're good."

This is also why Cyrus is waiting to complete this before fully tackling Nash. It's not on hold but we don't have bulletproof safety information to share. At least we didn't until Cyrus started the process properly. It's taking a lot of time because it was a lot of fucked up. They had to gather information from trials that happened many, many years ago.

I don't think there's a ton left they can nitpick about once this last submission is complete. And I think they're asking for an HIV plan because we have ongoing HIV plans with cure and long term dosing, but also because any plan they had submitted in the past is probably garbage because Amarex was involved.

That being said, if they come back with more and this drags out more than another month or two I'll be screaming sabotage like everyone else.