Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-539

Aloha,

"I cant believe that SI has been blindsided by these questions."

I think you're right.

And, after a bit more reading, I want to correct a comment of mine above. I thought our document was prepared "hand in hand" with the FDA. That isn't the case. FDA had our document, probably for weeks, and has stitched us up.

Why do that?

I don't think it was to make a pr*ck tease out of the whole process.

I think it was to set the bar very high, as everyone keeps saying for the "paradigm shift" and not only for us but for all those who follow including competitors (a good thing).

In the Eli Lilly Adcom I referred to, they filed an Addendum document. I expect Mesoblast to do the same. I think Silviu will be shocked and feel somewhat betrayed, and it will be crisis management time. No doubt from Melbourne to New York they are running around like blue flies, getting their shed together. Remember these guys have much more to lose than any of us.

The Addendum is needed so that the Committee members have time before the meeting to properly consider what will (hopefully) be a very detailed and compelling rebuttal of the FDA criticisms.

GLTAH!