Oh it's reality you want .... here you go:
1. 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)
for a multi billion dollar blockbuster indication.
2. Mesoblast have a Pre BLA meeting scheduled with the FDA following the Type B meeting held with FDA on February 21, 2024 whereby the FDA were happy enough with the data from the phase 3 DREAM-HF the LVAD trials to support an Accelerated Approval (AA) pathway.
(You do understand what a BLA submission is for don't you ?)
3. Mesoblast secured a multi billion dollar partnership deal for CHF over a decade ago
prior to the data from the DREAM-HF phase 3 trial data - you know the same data that the FDA said supports an AA pathway after their Type B meeting.... can you imagine what a CHF partnership deal looks like now with an RMAT Designation and the FDA supporting an AA pathway for same with the Pre BLA meeting happening in the near future?
https://www.genengnews.com/topics/translational-medicine/cephalon-shells-out-350m-to-commercialize-mesoblast-stem-cell-therapies/#:~:text=Cephalon is paying Mesoblast $130,adult stem cell technology platform.
Cephalon Shells Out $350M to Commercialize Mesoblast Stem Cell Therapies
Deal includes $130 million up front and a $220 million equity payment for a 19.99% stake in Aussie firm.
Cephalon is paying Mesoblast $130 million up front and will make a $220 million equity investment in the Australian firm as part of a collaboration to develop and commercialize adult mesenchymal precursor stem cell (MPC) therapies based on Mesoblast’s adult stem cell technology platform.
I could go on but clearly facts are wasted on you as you have a very limited understanding on what the FDA process is or what the developments mean for the company .... I can wait as I didn't invest in Mesoblast for sr-GVHD so if it gets approved it is just a bonus - the CHF indication is where the money is no matter what naysayers like yourself post on HC .... enjoy your day
(20min delay)