A reading of that by this non-lawyer makes it look like the FDA is the defendant.
If anyone really thinks that MSB is vulnerable here please join the dots and don't apply innuendo.
"The FDA briefing documents stated that it is “unclear” whether the study results supporting Mesoblast’s application are “relevant” to the proposed indication for use."
So the FDA doesn't say that MSB has misdirected anyone, just that the FDA can't see the relevance of the provided study results. So what? They've just been piled on by a 9 to 1 majority that should have clarified their vision.
Can't say I'm worried by this fishing expedition.
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