I’m not too worried based upon the draft version that was put out for comment. The large institutions that own this company surely have eyes and ears in the medical community and if it wasn’t looking good, I think we would know, if you know what I mean . I think at the very least, Arikayce is included within the confines of FDA approval. My guess is that it will be included as one of three acceptable forms of Amikacin. IV, Inhalable and liposomal. In other words, it will be one of the big three.
https://
www.escmid.org/escmid_newsletter/19_march_2019_escmid_weekly_news/