Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-185

Hi @Sponge,

I had an opportunity some time ago to examine this potential operations cost issue for MSB.

On one analysis, there are 2 broad ways that 'sweet, sweet money' might be a reason for the FDA to "say it appeared sufficient for resubmission if it appeared that it was not approvable" i.e. properly & improperly.

Re the first, MSB holders should be aware of the cost savings for MSB built into the current Prescription Drug User Fee Amendments, viz:



Link here.

IMO, Mesoblast Ltd would not have to shell out to the FDA any "sweet, sweet money" to have any resubmission of the RYONCIL BLA accepted for filing and/ or reviewed fully by the FDA in a new review cycle i.e either because RYONCIL's paediatric indication is covered by an ODD (as it is & has been for some time), or alternatively because MSB has already paid the fee on a BLA that was accepted for filing but not approved by the FDA at the time.

So, then re the second, please do tell all HC:MSB readers in great detail exactly what improper way you might be suggesting that the FDA received "sweet, sweet money" in connection with the recently ASX-announced RYONCIL resubmission, & from whom exactly they received it.

Or you could just withdraw the suggestion. As the animal act it was.

GLTA(LT)H