That is an absolute and misleading statement to make.
If they are 'not happy' why would they request further evidence to consider the 2mg/kg?
Asking for the complete suite of information that supports the dosage actually sounds encouraging to me. They wouldn't put themselves through this burdensome extra review work if it was going to be clearly a 'No'. Rather, it suggests the collection and review of all available data to support a 'yes'.
Where we at?, page-338
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