Ann: Rexlemestrocel Greatest Benefit in Diabetics and Ischemics, page-288

That is true, I felt that this time last year prior to all the results being released was yet another critical junction in this company's history... and while the market saw those trials as fails.. I didn't, which is why I've stuck around... and from what I can tell.. the FDA have effectively turned both the CLBP and CHF 'failed' trials into successful ones. But I don't think the wider market has quite worked that one out yet.

I don't think Mesoblast are the first or the last biotech to get played by a big pharma... the team Silviu was dealing with may not have had the final say on the matter if my experience with large corporates is true in this instance. So I feel he may have been blindsided along with the rest of us, so without knowing exactly what was said and discussed.. it's obviously tainted Mesoblast's reputation as well his Silviu's... but all he can do now is deliver on his core business and rebuild that trust.

On the LVAD trial, I believe it was fully funded by the investigators so Mesoblast had little to no say in the actual trial design... they simply supplied the product, and there was no cost to Mesoblast financially.. but of course the results of that LVAD trial had again reputational damage, but as you mention some useful data was learned.

On the CLBP call... I admit they could have been clearer and although the market punished the stock price for the CHF trial result announcement.. where they clearly said the primary endpoint was missed.. I preferred that. But I was told that the CLBP announcement was their attempt to learn from feedback received from how they handled the CHF results.. where shareholders and the like complained it was too upfront.. and didn't focus enough on the positives... resulting in a bad market reaction. So they took the other extreme of focusing on the positives for CLBP, which in the end.. was validated by the FDA that they were actually right to focus on the amazing pain results... but that probably was taking it too far in my view. So agree with you there they should have been more upfront there.

But on a lighter note... I found it an interesting thought to compare what happened leading up to the FDA CRL and where we are now leading up to the OTAT outcome. So at around $5 a share, the market expected a positive FDA outcome due to the overwhelming ODAC vote of 9-1. But in hindsight of course, I can now clearly see that the ODAC vote was the red herring.. and that all signs lead to a CRL, that is the clearly combative stance the FDA / OTAT had on potency assays, MOA and manufacturing.. .as well as the question marks over efficacy. But the market ignored that and focused on the ODAC vote.

Compare that to where we are now leading up to the OTAT... I believe the red herring is the Novartis termination of the collaboration.. the market is clearly factoring in the fact that Novartis may have seen or heard about the OTAT meeting, and that is likely to be negative and lead to further delays.. however as articulated in my previous post, the FDA are actually in agreement with Mesoblast on the path forward and the data and process required to address the CRL point on potency assays.

So in hindsight, what we should have done leading up to the CRL we should have focused more on the FDA's guidance/views.. and less on the ODAC result. And my opinion is that in this instance, we should also focus on the FDA's guidance/views and less on Novartis.

Again all of this is just my opinion, and lets see if my way of trying to learn from what happened with the CRL debacle last year.. and trying to better predict the FDA outcome leading up to the OTAT minutes works out... or if we will again have the rug pulled from beneath us.

Goodluck