2024 Here we go again., page-286

"Dr, Itescu also said that they have supplied more than enough data to support this second potency assay review.


To be fair he said similar about the last BLA submission ..... and if the FDA want to wait for the adult GVHD trial where will that leave the partnership negotiations on other indications as the current depressed share price will likely tank further ?


If the last two FDA announcements in relation to the CHF indication combined with the DREAM-HF phase 3 trial data and the LVAD phase 2 data isn't enough to command a buy in of $1.00 per share then I would be surprised - time to get a big pharma third party involved in this AA process IMO and subsequently provide some market confidence through the involvement of an 'outside' party ....


...... an announcement signifying the FDA support an AA pathway for a blockbuster indication on any other biotech on the ASX would have sent their share price rocketing - tells you where the market perception is with Mesoblast based on past FDA experiences IMO (sadly)


GLTAH