"They need to somehow encourage the use of Rem-L with pediatrics so they can collect this data. It will be easier to encourage this use with an FDA approval rather than another expanded access trial."
SI has hinted collection of this data may only be possible with FDA approval. I suspect Mesoblast's argument will be that they do not have enough product available for an EAP since they will need to supply enough for 400-500 patients, or more. This will then put the ball in the FDA's court to make a decision according to the risks vs benefits.
DYOR, my opinion only
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-740
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