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