Mesoblast and Big Pharma...., page-8

I think that most people who work in pediatrics (along with most of the rest of us) don't particularly like the idea of not giving children the best chance at life they can give them especially if they are directly involved. A 2 arm trial usually involves the use of a placebo, i.e. nil treatment above the best standard of care. In this instance at the time of the trial starting that means a high death rate, around 65-80% or higher depending on the areas of the body affected.

Remestemcel-L already had a fairly good response rate at the time the single arm P3 trial started, around 70% survival using the same measure based on the results from the long running Expanded Access Protocol (EAP) treatment available at the time.

I suspect those intimately involved with the P3 trial had no desire to expose children to a rather lower survival rate than what they could get outside of the trial under the EAP.

I don't believe the dissenting panel member worked with pediatric cases, but if what you report is accurate, fine it was a principle thing. Where possible P3 trials should be at least Placebo controlled but there are times when there are or need to be, exceptions to rules. A work around with a group of children who received the best international standard of care were provided as a control group. The difference in survival at 180 days is quite stark, in favour of remestemcel-L.

Perhaps you should review the materials provided to the ODAC panel, i.e. DYOR. I believe full recordings of both sessions are available too.