Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-477

Hopefully someone can help on this

for the questions around manufacturing raised in FDA paper.

can someone with scientific, manufacturing or research background explain
why can't the questions raised by FDA be answeif red based on manufacturing processes used in Japan or what Lonzo is planning or doing?

can't the existing manufacturing process answer it including results from actual use of the drug/stem cell in Japan from patients there sincd it is approved there and sold?

comments from someone with experience and knowledge in manufacturing processes used in Japan and by Lonoz to answer some of questions will be appericated