Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-366

Tobias,

I've normally found the IR guy (Paul Hughes quite accommodating). The trial failed its primary endpoint as other posters have pointed out, by it including significance 'though'' 24 months - it was just over 0.05 at 6 months, but well under at 12 and 24. I am no trial expert and understand the FDA may have been insistent, but it would have been nice for them to explain (or an analyst to ask) why they had a six month review (the only where significance was not met) in a pathogenisis that evolves over years and is never going to show significant improvements at the six month mark

I will not be popular for saying it, and perhaps the FDA was the culprit with trial discussions, but having a six month end point in a chronic degenerative disc disease trial seems absurdly optimistic and onerous to a regulatory trial in my opinion. Whilst MSB has certainly been the brunt of some unfortunate circumstances and decisions in its trials, I am getting very tired of the clear suggestions of efficacy, but failure of endpoints for regulatory purposes. At $2.60 MSB is a clear buy and why I am still in, but I for one understand your disappointment with some of the communication. I made the point in the past to Paul (that he did not disagree) that any trial failures should be readily and clearly explained to investors - CHF did include all of the MACE endpoints as pre-specified but it was not immediately obvious. I'd give MSB a C+ on this one at best....another buying opportunity for the long run. The treatments work, but patients and investors will alas have to wait longer for commercial availability.