the thing i'm still trying to understand is this.

the thing i'm still trying to understand is this. We provided all of the requested info regarding the safety of LL to the FDA (to prove that the death in question was not related to our drug). The hold was based on safety - and nothing else. Assuming they reviewed that data - and it proved LL did not in fact cause the death, the hold has to be lifted, right?

I mean, the fact that they they pivoted to our plans in HIV, vs the safety issue itself, suggests that they must not have further concerns over safety - otherwise, their follow up would be more safety-related questions. So the hold has the be lifted. Fine if they want to say "the hold is lifted - please provide this additional data". How is that not the outcome?

Honestly though, i'm not overly bothered by this.......Serenity Now, Serenity Now.......