I respectfully disagree. How many times and in every sphere have people thought that it was "in the bag" only to be shocked by an diverse outcome.
If nothing else the FDA must be made aware that their actions will be scrutinized. Big Pharma's lawyer made a cogent argument that the trials were not rigorous enough. That is the "data" the FDA could seize upon to deny approval.
It must be impressed upon the FDA that Rem-L is effective and safe quibbles about the protocols be damned.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-259
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