Investigation of Mesoblast Limited (MESO) on Behalf of Investors, page-47

ah it seems the FDA reject the biomarkers as that proof.

It is an important point as In the FDA view, the Phase 3 was not designed well and older trials actually pointed to failure. Perhaps a single arm study would have been approved with better historical data and not so much weighted argument in use of surrogate endpoints to prove MOA?

There has been a good point raised on here about how the consistency issue come out of nowhere.

This is more than regulatory risk.

This is platform risk that to me, and I am very happy to be corrected as I own MSB with an unrealised haircut, when has this been articulated clearly by the company?

Are their biomarrker surrogates valid or just post hoc affirmation to add weight to what now seems like a claytons Phase III success for aGVHD?