SPEAKER 1: Liposomal amikacin has been approved by FDA after converted study. I've been PI at Miami VA for this study. This study was multi-national, multi-centric study, including United States, Japan, Europe, and rest of the world, and included more than 200 patients. And those patients receive conventional treatment, plus liposomal amikacin. And compared with 104 patients without liposomal amikacin.

Both groups been treated at least for six months with conventional therapy. As discussed, as macrolide, plus rifampin, plus ethambutol, and fades with continuation of sputum positivity after six months. And then follow-up for at least six months. And interestingly, after four months in the group that liposomal amikacin was given, almost 30% converted sputum. But in control group that just use conventional treatment, less than 10%, and exactly 8.9%, converted to sputum. And that was statistically significant between two groups.

This result has been published with American Thoracic Society Journal in 2018. And based off this data, FDA granted to this company to market medication that right now we have access and we have been using for our patients.