The label expansion will be a supplemental BLA or sBLA. This will likely result in a faster approval as it would only be an extension of the combo approval (once approved).

I’ll admit I’m not very knowledgeable about the off-label use and both Fine and Misiu are in similar thoughts that off-label use could be significant, so I’m probably misunderstanding something. I don’t understand this as I see a conflict between insurance payment approval and doctors diagnosing patients as combo eligible (R2+) to be eligible for off-label use. I could be wrong, but IMO seems pretty risky for a doctor to prescribe someone for combo to have them throw away the HAART drugs and use it as mono therapy in order to get insurance to pay for it. If it is common for insurance to approve payments for such mono treatment before approval as off-label that would resolve this conflict, but I don’t think that is likely.