December 10......was how many days after the AdCom??? You call to ask these questions related to the chemistry, and the manufacturing NOW??? On what do you base the "priority" review, then? Without knowing the most miniscule details of things like chemistry and manufacturing process, you wait until 70 days or so until PDUFA to ask more questions??? The homework assignment isn't even done. Let alone the exam material. Good thing no one is grading the FDA on the integrity of their system. "F" :(