Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-144

“only news all year” he says … I guess that confirms you’re still in denial about all the positive CHF news including the FDA Accelerated Approval pathway recommendation in March … lol




UNITED STATES FOOD & DRUG ADMINISTRATION (FDA) SUPPORTS ACCELERATED APPROVAL PATHWAY FOR REXLEMESTROCEL-L IN END-STAGE HEART FAILURE PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD)


Melbourne, Australia; March 11 and New York, USA; March 10, 2024: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor® under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.