End of public hearing session.Commencement of Questions to the...

End of public hearing session.
Commencement of Questions to the committee and panel discussions.

Initial Discussion: Discussion of the adequacy of the potency assayestablished by the Applicant for remestemcel

*long pause before anybody asks a questions, things are a bit awkward*

Question arises as to how MOA can be measured
*question is finally asked, Steve sweats a bit thinking the question is forhim, redirected to MSB*
SI handles question like a champion - points to some graphs, examples ofmeasures, supports information with so much evidence. TNFR correlation,biomarker MAGIC scores, and T cells.

Ex: 18-32% Day 28 response, versus 61% response for those treated by theproduct.

*slide person can't keep up with SI*
I won't put in too much from SI, just the overall consensus, as we have allread the information already I'm sure.

"Dr Robey, are you happy with the response?"
Dr Robey: Yes. Thank you.

"Does anybody have any questions? Dr Morrisson?"

Dr Morrisson:

The Mesoblast mechanism is likely complex is also well taken.

This involves effects on multiple cell typesand multiple cytokines.

It's tough because most of the data related tomechanism the basics members performed in culture.

It's a lot harder to do these extremities.

We have much less data on what these areactually

doing in vivo.

There's reason to believe there isheterogeneity in the product.

With such a complex mechanism of action, thereare real concerns about knowing how tom easure potency and predict