Pick Today's Price Range Low-High... Just for Fun, page-1119

Clueless as usual I see @cheesepope .... no idea what the Accelerated Approval process entails (obviously) nor the doors the RMAT designation opens


@Hawk70 it is a Pre BLA Submission meeting so it is likely to be all about the BLA data expectations etc and subsequent confirmatory trial protocols (Phase IV) Not sure the activity update on 29th August will be about it as the comments in the prior sentence in the Quarterly mentions Ryoncil / GVHD but who knows with Mesoblast ?


“We are executing on our go-to-market plan to bring Ryoncil to the many children suffering with the devastating disease of acute GVHD. I look forward to an activity update at our full year financials and investor call on August 28th 6.30pm EDT (August 29th 8.30am AEST).”



https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
_{Accelerated Approval Program}








GLTAH