Any thoughts of whether "Big Pharma" has had some sort of influence here. Protecting their monopolies. Making any new development that rival their cash cows difficult to be approved.
The fact that a curve ball was thrown past the 11 hour does not fit with the due process and the FDA should be held accountable if objectives and requirements are not clearly laid out on the table prior to or during the submission (can you sue the FDA or claim compensation?).
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