Hi @Barman76re your question on matrices, yes, that's so. Even...

Hi @Barman76

re your question on matrices, yes, that's so. Even the FDA were obliged to acknowledge & accept that Mesoblast has been following its own published Guidances on potency assay form and structure.

This from the ODAC AM Session (p.77, Steve Bauer PhD, Branch Chief, CTTB OTAT):

" ....Our [i.e. FDA] potency guidance included the use of multiple potency assays also called the Matrix approach. Because of the product's biological complexity, one assay may not be sufficient to measure potency. In this situation, we consider the use of multiple complementary assays that measure different product attributes associated with quality consistency and stability. Such matrix assays can consist of combinations of biological assays, or biological and analytical, or analytical assays alone. They also can have a quantitative or qualitative readout, however, a qualitative assay should be accompanied by one or more quantitative assays.

The applicant's [i.e. Mesoblast's] potency and activity test for TNFR1 and IL-2R alpha constitute such a matrix approach to potency testing."

However, its now becoming apparent (to me) that there are many other assays than release assays that are available to satisfy the FDA's remaining 'characterization' itches.

All good, IMO

Cheers