I definitely think FDA have set a high bar for stem cell...

I definitely think FDA have set a high bar for stem cell approval, in large part because of the unproven and unethical use by a plethora of back room stem cell companies in the past 10 years. FDA also, in my opinion, let Mesoblast know that the bar is high, and the pre ODAC guidance document was a shot over the bow that I wish I’d paid more attention to. I think they were pissed off, that’s how it reads to me now.
Mesoblasts single arm study is compelling, and clearly swayed the ODAC group, however, we should listen to the two things that FDA have made very clear.
They want RCT data ( even though that is not an ethical approach in children), and they also want more clarity on Chemistry, Manufacturing and controls (CMC) - and the relationship of TNFR1 to outcome measurements. FDA have told Mesoblast that they are not satisfied with either of these things.
There is a possibility that we may get approval for less than 12 yo SRaGVHD patients with an RCT in adults, but I’m not convinced FDA are going to budge on their position. Positive results in Covid ARDS RCT, may provide more sway, and I’m more confident we’ll have that at the 60% readout than the 45% readout.
expecting topsyturvey share price for next 2 months.
We may be surprised earlier with good results from the MIS trials before then.