Regenerative medicine company Mesoblast says it will seek to engage with the powerful US regulator despite mixed results from its highly anticipated phase III trial into back pain using its rexlemestrocel-L drug.Crucially, it wants to discuss with the Food and Drug Administration “if there is an accelerated path” for the drug as an opiate-sparing treatment for patients with degenerative disc disease.The company said that when looked at together, the outcomes of pain and function in the trials were not significantly improved by the therapy. This disappointed some Mesoblast watchers, who were asking further questions about why the results were delayed from their expected release last year
this sums it all up.
Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-385
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