CHF Accelerated Approval !, page-60

Everyone should just read again the below slide. The FDA is looking at this right now, and deciding whether to “invite” Mesoblast to apply for accelerated approval for ischemic diabetic patients with elevated inflammatory biomarkers. It’s a case of treating a patient population where there is significant unmet medical needs whom have a very poor prognosis, and with a treatment that has no known side effects, where efficacy is demonstrated with low “p” values to be much better than standard of care. Or the panel of Cardiologists at the FDA shall recommend another trial and delay the regulatory approval by at least a few years. Given that the current emergency criteria is met, as documented by the FDA, I believe that it’s a case of when and not if for this company. And I firmly believe that this day is coming soon.

After CHF, there shall be Crohns, CLBP, Knees, ARDS, Arteriosclerosis, Adult aGVHD, and a host of other inflammatory diseases which shall be treated with MSC’s. Only 2 weeks ago my elderly mother died from choking (RIP). She had a chronic inflamed oesophagus. The world shall embrace cellular medicine in the next decades, and Mesoblast shall be one of the leaders in this great field of medicine covering inflammatory diseases, with an intellectual property portfolio that covers a huge array of the different indications.