Ann: Rexlemestrocel-L Improves LVEF, Preceding Reduction in MACE, page-83

But let me ask you this. What would happen to the company if the FDA finds that the new potency assay isn't actually acceptable, even though the original "approach to the potency assay was reasonable"?


Someone's frantic today


It is funny to read your post and see that you muddy the waters by combining all Mesoblast treatments in it but then pose the above question at the end inferring that the future of the company is solely dependent on the Remestemcel-L potency assay being accepted by the FDA when it submits its BLA for GVHD ?


Rexlemestrocel-L is a totally different product being applied to two very different indications (CHF & CLBP) so if the FDA said no to the Remestemcel-L potency assay then it would have no affect whatsoever on the Rexlemestrocel-L potency assays, which by the way were previously agreed upon years ago prior to the FDA letting Mesoblast undertake the phase 3 DREAM-HF trial, but I am guessing you already knew that ?




We get it after about 20 posts today from you on a stock you don't hold - you don't see the FDA looking at an AA approval pathway for the high-risk HFrEF patients with diabetes and/or myocardial ischemia but I can see why the actual experts in the cardiology field do ... just like with the CR argument you have posed numerous times today, we will see who is right or wrong - the actual cardiology professionals / experts or an anonymous poster on HC ... I am tipping the former but we will see as 2022 unfolds I guess ?