It is fair to question why the FDA allowed mesoblast at their...

It is fair to question why the FDA allowed mesoblast at their own expense, to operate an EAP exclusively for children 12 and under….using Ryoncil….a novel therapy that DID achieve PE, DID achieve exceptional phase 3 trial data….that DID receive ODAC 9-1 support for approval…..that DID consistently achieve survival rates far in excess of their own approved SOC Jakafi ……was not restricted by either clinical hold or partial clinical hold throughout the 1-4 years of operation …..I could go on with other positives ….but despite this overwhelming evidence..,received another CRL…..?????? Very hard to comprehend on a fair playing field.