Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-260

Dealmin, “it was a stretch by OP to assume something similar was not in place.”

@dachopper


I think something has been lost in translation. I am sure Mesoblast has everything in hand to offer alternative potency assays to the FDA for other conditions with multi factorial mechanisms (which is why I suggested Mesoblast has been aware of this for some time). I was merely pointing out that for steroid refractory aGVHD I believe Mesoblast has a potency assay whose relevance has been shown to be central to a largely T cell mediated disease. For CHF, Meso might choose to propose supplemental assays to the FDA which reflects other activity (such as M1/M2 macrophage based conversion for example ? ARDS might have a potency assay that reflects activity in the lungs ?) We will no doubt be informed in due course although the IP will be closely guarded, as competitors lacking comprehensive phase 3 clinical data of their own might be desperate to find validated potency assays acceptable to the FDA.
I believe the current potency assays used may be very applicable for multiple indications and have specific relevance to various IBD related diseases.
I am encouraged by current feedback from the Cleveland Clinic on using bone marrow MSCS for treatment refractory Crohn’s and UC patients not to mention peri annal fistulas.. and I see the prospects for adult sr aGVHD as a shoe in if MESO commit to a further RCT in adult patients.

In my opinion the next FDA convened meeting on CHF will be one to watch ! The Company has recently had to focus on the BLA resubmission to date but they are extremely aware of the potential for accelerated approval pathway in a narrow patient category such as LVADS. Watch this space ! OP


Please do not rely on the opinions expressed in the above post when making an investment decision. I am not medically qualified,