CT Medic, why will we not have a HIV BLA this year

CT Medic, why will we not have a HIV BLA this year? Isn’t it a simple matter of answering their questions regarding our filing - two items? The 700mg data from the S/C trial answers dosage issue. The needle problem can be solved by simply shipping Leronlimab without any needle - buy your own FDA approved needles or go have it administered in a clinic. Why would we have to wait until next year to receive approval? The FDA already said they had no problem with the safety and efficacy of Leron in that trial...