RE:RE:Everyone should just take a step back and calm down.Hurt, Is there any recourse with the FDA, maybe in the form of an appeals process seeking a parallel trial, expedited trial or lesser/limited indication? I am not well versed in the apparent "all or nothing" nature of this BLA. There was significant discussion around the "surgery unable and unwilling". Are those people essentially SOL with no option available? Everything points to the dreaded "binary event" but I think that the circus act and race to $0 is a lot more dramatic than the facts on the ground. Last question, why did the CRL mention a second trial to establish safety? Were we not told that the safety factor was a non issue and the BLA was an efficacy driven application?