" the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. "
I put it to you Whytee for the purpose of understanding what the recommendation actually is, if MSB conducted another trial, and it showed no evidence - would MSB be approved.
On the contrary, if MSB provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD, without conducting another trial, would it be approved?
Has MSB provided further evidence of the effectiveness of remestemcel-L for SR-aGVHD ?
1 year survival data 2 year survival data 4 year survival data Control arm statistics provided by CIBMTR that supports MSB's null hypothesis. Control arm statistics compared from Reach 1, Reach 2 and the largest child gvhd study undertaken - that all support the effectiveness of remestemcel-L. Treatment arm statistics from Reach1, Reach 2 and another trial, EAP275 also all supporting the effectiveness of Remestemcel-L. Potency assay data that correlaties with survival outcomes.
What more could they possibly have gotten, by completing another trial, that would be more than, or better than the evidence of efficacy they just added?
MSB Price at posting:
$1.16 Sentiment: Buy Disclosure: Held
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