I will admit that I've sold out about 90% of my holdings today,...

I will admit that I've sold out about 90% of my holdings today, as the medium term investment outlook has changed. I'd be looking to return at least around CR pricing ($3.20).

The wording from the FDA briefing suggests that they will want another trial with a more robust procedure before approving the MSC cells given their strongly risk-adverse opinion on stem cell treatments, and the trial outcomes are not nearly strong enough to suggest overwhelming efficacy that many of us here believed would eventuate.

What remains the saving hope is that Mesoblast's MSCs are very safe and have few in the way of adverse effects. Their focus on procedural rigorousness suggests the FDA will be more likely to use the larger previous trials as opposed to the most recent trials. This suggests that the barriers for even the other indications that are being sought are going to be a much higher hurdle to overcome than we've expected.

People quoting stuff from Mesoblast's own briefing documentation saying that it's effective is meaningless -- obviously Mesoblast are going to say their own product is effective and find some markers which suggest some sort of effect. To be very clear, it doesn't mean that remestemcel-L doesn't work, but that it's going to take at least another three years or so before we can deliver the gold standard evidence supporting approval for paediatric SR-aGVHD and other indications.