Mesoblast Company Update - Webcast and Forward Thoughts, page-40

I was honestly of the opinion the FDA would push it through due to the unmet need and severity of AGVHD
in children. The only thing to be taken from this result is purely statistical evidence of efficacy.

An extremely crap result and a very controversial one I have found after speaking to some medical and money market professionals.


At the end of the day if your a short term holder the market confidence has gone down but believe me the only reason is due to lack of a large patient cohort. I will not defend the FDA on this however this is a long running protocol, significant numbers in trials. Not to mention ryoncil being essentially a stem cell derived product.

Ryoncil will be a world first. I go over confidant, and that's just how it is. A treatment of this kind will go through more hurdles then anything we have previously seen. even if it's a historic first rejection.