Yes, they are targeting accelerated approval with a confirmatory trial and will meet with the FDA to discuss pathway forward on the basis of the significance of the p-values achieved and the fact that it was a huge paradigm shift in the treatment of lower back pain. An analyst called it a "watershed moment" for the industry.
MSB and the team are in commercial discussions for partnerships within the USA, but due to the size of the market they want to make sure the alignment is as strategic as possible. Briefly discussed that they may go it alone, although I think SI is just saying that to increase the 000s on any commercial deal and to drive a hard bargain.
Great results again for MSB, and nice to see SI feeling positive and the team upbeat about approval and commercialization.
Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-74
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