Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-59

Mesoblast appear to be inferring that they have the data required to link potency with in vivo activity...which is the remaining bugbear of OTAT. We have already seen peer reviewed research regarding ST2 biomarkers and MAP scores for sr aGVHD. They obviously have a whole new dataset but have chosen to release the new data, as protocol would normally dictate, at the time of BLA resubmission.
The obvious question is : Why would they resubmit a BLA if they had any doubts that they could not achieve the requisite standard of proof?
The statement appears to also suggest that OTAT believes our outstanding CMC issues from the issued CRL have been addressed in a “reasonable” way…….I am afraid OTAT do not get more descriptive than that…..but it’s a great tick in the box.
Now we will need to see if/how this unlocks the opportunity for a further Covid ARDS trial ?

With CMC and safety modules apparently successfully navigated….we are just left with the new data on efficacy. I believe the Company is quietly confident that considerable progress has been made and I am am inclined to think approval mid year ...although there still remains the possibility of a PDUFA date in the next quarter if Peter Marks wants to bring events to a speedier conclusion. With OMICRON in full blast you would think these nerds would have the common sense to fast track the crap out of this therapy !

Happy New Year to all.

OP

Please do not rely on the accuracy of any facts or opinions expressed in the above post when making an investment decision.