Ann: Appointment of Dr Howie McKibbon as CEO, page-54

Mesoblast's rejection is a lot different. After having their FDA approval rejected 2 years ago, the FDA requested MSB do further trials. MSB chose to ignore that advice but rather resubmitted their application with additional data from elsewhere. That wasn't enough to change the FDA's mind, so they rejected it, again.

BOT on the other hand have submitted an application for a drug already approved by the PMDA (the Japanese FDA equivalent), where the FDA have completed a mid-cycle review without issue, where nearly two years of use in Japan has caused no concern, and the FDA are discussing labelling choices with BOT.

However, technically, anybody who says the FDA could reject BOT's application is correct. It's just that the likelihood of that is minimal to almost non-existent.