Ann: MSB Q2 Financial Results and Operational Highlights, page-5

missed the first half of this investor call, did I miss anything?

But the back end of presentation and Q&A very positive and insighful investor call going on at the moment... great Q&A... OTAT and CBER interaction has been very collaborative post CRL, with Mesoblast being told exactly what the FDA want to see before approval and Silviu has said they have exactly that in hand.

Singapore manufacturing site was not inspected in the first review process, but Mesoblsat expect the review timeline (max 6 months) to be driven by inspection of that facility.

New data submission will be evaluated as part of resubmission, so next step is resubmission. No additional OTAT meeting requried prior to resubmission.

Dr Rose demonstrating his experience as a surgeon already talking about ulcerative colitis and crohn's colitis... as well as MACE outcomes of CHF patients and obviously has a strong understanding of the history of our clinical trials. CLBP trial discussion sounds very positive, with Mesoblast going above and beyond what FDA require in pain reduction i.e. 50% MSB threshold vs 30% FDA approvable.

MACE outcomes was the phase 2 and initial phase 3 primary endpoint, but was changed by Teva at the back end of the phase 3 trial. MACE outcome achieved in our phase 3 was 'remarkable'. FDA asked what would be the patient population that would result in the greatest public health benefit.

Mesoblast were 'staggered' by the effect size achieved in CHF phase 3 trial, especially in the ischemic and diabetic patient population. FDA didn't want to look at subjective patient populations such as Class II or Class III. Next step is a formal meeting with the FDA. Very tight lipped on whether another trial is needed.

Jason Kolbert giving Dr Rose raps referencing his part interactions with him as a former CEO and Board member... now CMO at MSB.

ulcerative colitis and crohn's colitis pivotal trial is likely to be small because control patients will perform so poorly. control in first 12 patients did not respond at all. Whereas treated had 100% response.

Current colitis phase 2 may not need 48 patients and may be stopped early. Investigator may conclude that results are so positive that they recommend stopping the phase 2 and going straight to pivotal trial. With the data to date, if that continues for one more read-out, it sounds very highly likely.

Tanu Jain is still calling in, through Petra Capital now, nice to know she is still advising a new investor base on Mesoblast.