Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-16

A bit different to what SI supposedly said to the journo at The Australian Newspaper recently but hey at least the BLA is finally resubmitted ?   A 2 month review would confirm the FDA is eager to get the treatment on the market IMO..... if we get a 6 month review (although an answer can come sooner) I won't be as enthused.  I would also temper your expectations in relation to the share price reaction off the back of this announcement as it is only the lodgement stage ... nothing to see here until the FDA issue a PDUFA date and / or approval.


"appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SRaGVHD"


Now get on with the CHF indication and accompanying partnership deal where the real money is $$$