2024 Here we go again., page-181

I don't think you are saying anything different to what SI is saying.

For Rex-L CHF SI have said that we've done a P3 and now will be doing a second P3, but we are also in the midst of discussions with the FDA around AA. The FDA have not done Mesoblast any favour, nor should it, so it's better to get these thing cleared before the second P3 trial commences on CHF.

So you are correct with you AA statements - I have no issue with this.


But now, humour me this...
My understanding is that MSB will go with plan A for full approval for Ryoncil for Pediatric by answering the CRL item with the new Potency Assay data - if that is successful, then that would be the ideal outcome - that's plan A.

If plan A fails, then MSB will be looking at an AA pathway with the commencement of the Adult GVHD trial - that's plan B.
AA requires a surrogate endpoint to "predict clinical benefit".
What prediction, aren't we beyond that point already - FDA selected a panel to be on ODAC for Ryoncil and they have voted 9-1 on efficacy already.
So why would we need to have a surrogate endpoint to "predict clinical benefit".
Can you give me your thoughts here? As, this is very confusing state we are in.

How can plan B be executed?