Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-73

Agree OP- I would even say 3 months is possible.

No Adcom to be held - already approved efficacy with a 9-1 vote

No 483- that is spectacular- Lonza must have blown their socks off. - manufacturing processes approved

All Clinical data to do with phase III trial already reviewed - zero safety concerns.

All the above is at least three months work.

Add in the zeroing in on specific requirements/issues/problems raised by the second CRL , decreases the timeline even further

Three months- even less , to go- to complete the PDUFA process.

Sweet baby Jesus- you would want to be holding for an approval-

No FOMO for moi- locked and loaded



Good luck to all the beautiful people




Reg


Now lets close on a high, last acceptance day - turnover 13,481,022 shares- already over 20,000,000 today xxxxxxxxxxxxxxxxxxxxxxxxxx