Few highlights from broadcast to date.
“ unprecedented “ drop in pain for people in desperate need.
Compared to opiates, significant pain reduction.
looking for accelerated path with FDA
Know functional measures needed to move forward.
P values were significant in reduction change of pain. Self evident. Much stronger . Very positive . Regulators COULD approve straight away.Cannot be ignored by FDA. But might need another study. No alternatives. Could use of opposes hazardous, overdoses doubled. Opioids sparing.
Business focus
Will meet with European regulators to consider path forward
In commercial talks with USA companies.
Might consider going alone.
FANTASTIC
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- Ann: Mesoblast Phase 3 Chronic Low Back Pain Results
Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-46
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