GvHD in children has no current treatment, and mortality approaching 90%. That fits the purpose of the accelerated approval program - which is used when a product would normally require another trial, but there is unmet need.
Accelerated approval requires post sale confirmatory phase 4 trial - which is what the company said it is asking for, and they would conduct it in adults.
So unless the FDA want to go against their own program advice, and the panel of experts they asked for advice from given they have almost no experience in Stems....Mesoblast will get what they are asking for.
the above is my opinion, which will be proven wrong or right " in short order "
MSB Price at posting:
$1.48 Sentiment: Buy Disclosure: Held
(20min delay)