"That is along the lines of the Canadian regulator"
In the USA, with their regulator, that's the FDA, the closest to that is what they call a Phase IV trial. Post conditional release where people who have been treated and meet the previous trial criteria have their response and other data collected. The FDA then requires that data within a specified time frame to consider full release.
I would expect Mesoblast would receive full revenues, the product has been conditionally released to all people in need.
And that is if the FDA needs more patient data, that is not what was asked for it would seem.
"That is along the lines of the Canadian regulator"In the USA,...
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