Australian newspaper article, page-75

Mesoblast was asked for additional data, and went back to the FDA in January, expecting to be told what more needed to be done on the study front.

“And instead, what they said was ‘no, we’ve thought this through, and you’ve convinced us that the clinical data are very strong’,’’ Prof Itescu said.

“You’ve got enough to get approved for children – go ahead and file, and then consider how to take the product into adults.’’

i know I am going to get shot down for this, but this is a very careless statement to make without the actual approval. This, from the person who only recently lambasted shareholders and the greater investment community for having unrealistic expectations. Well, who sets those expectations when we have direct quotes like this in the newspaper.

Anything less than a drive through on the FDA approval for aGvHD runs a very big risk of a class action IMHO. Sure there are ways to weasel out of it but from a pub test point of view......