Well it seems worth the company meeting with the FDA to discuss the results and explore potential approval pathways. I guess you don't do something like that unless the results are compelling.
"Mesoblast will meet with the FDA to discuss the results from this trial together with the earlier randomized controlled trial of MPC + HA, and potential approval pathways for rexlemestrocel-L + HA as treatment for durable reduction in CLBP due to DDD with opioid sparing activity."
Well done MSB. Great news.
Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-27
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