Personally, no, the FDA never seems to make a decision speeding up the approval process. It would require breakthough status. Is leronlimab a breakthrough? Well the first possible mono approval, no developed resistance in 830 patients, combo trial with twice the efficacy of past approvals. No SAEs in 15 years. Better safety, better efficacy, lower toxicity, no resistance development. Longer half-life, with once a week dosing. Many of these patient developed resistance by skipping doses, they would allow them to be covered if they forget to take their pills a couple days. Yes, I believe 100% leronlimab is a breakthrough, but will the FDA give it. Who knows with them, I kind of doubt it at this point.

But getting Part 2 done would be a great step.